Amgen And UCB Announce Positive Top-Line Results From Phase 3 Study Evaluating Romosozumab In Men With Osteoporosis

Amgen and UCB announced positive top-line results for romosozumab from the pivotal Phase 3 placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis (BRIDGE). These data showed the BRIDGE study met the primary endpoint, demonstrating a statistically significant increase in bone mineral density (BMD) at the lumbar spine (as assessed by dual energy x-ray absorptiometry) in men with osteoporosis treated with romosozumab compared with placebo at 12 months.

All secondary endpoints comparing romosozumab with placebo were also met. Patients receiving romosozumab experienced a statistically significant increase in BMD at the femoral neck and total hip at 12 months and a statistically significant increase in BMD at the lumbar spine, femoral neck, and total hip at six months, compared with those receiving placebo.

Romosozumab is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the protein sclerostin, and has a dual effect on bone, both increasing bone formation and decreasing bone breakdown. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab. 

PFIZER TO PRESENT NEW DATA ON INVESTIGATIONAL TOFACITINIB AT THE 11TH CONGRESS OF ECCO

Pfizer Inc announced today that seven abstracts reporting on new research for tofacitinib in ulcerative colitis (UC) and Crohn’s disease will be presented at the 11th Congress of ECCO, which will be held March 16-19 in Amsterdam, The Netherlands. Among the abstracts are detailed results from two pivotal Phase 3 studies from the Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) program. Tofacitinib is being studied as an investigational treatment for adult patients with moderate to severe active UC.

The full list of abstracts to be presented at the 11th Congress of ECCO follows:

Ulcerative Colitis

1. Efficacy and safety of oral tofacitinib as induction therapy in patients with moderate to severe ulcerative colitis: results from two phase 3 randomized controlled trials (OP019, Friday, March 18, 15:40 - 15:50)

2. Improvement in patient-reported outcomes in two phase 3 studies of tofacitinib in patients with moderately to severely active ulcerative colitis (P369, Friday, March 18, 12:20 - 13:20)

3. Tofacitinib plasma concentration monitoring is not needed for optimization of induction therapy in moderate to severe ulcerative colitis: results of pooled exposure-response analyses of phase 3 induction studies (DOP071, Friday, March 18, 18:54 - 19:01)

Crohn’s Disease

4. Efficacy and safety of oral tofacitinib for maintenance therapy in patients with moderate to severe Crohn’s disease: results of a phase 2b randomized placebo-controlled trial (OP021, Friday, March 18, 17:10 - 17:20)

5. Efficacy and safety of oral tofacitinib for induction therapy in patients with moderate to severe Crohn’s disease: results of a phase 2b randomized placebo-controlled trial (OP022, Friday, March 18, 17:20 - 17:30)

6. Effects of oral tofacitinib on patient-reported outcomes in patients with moderate to severe Crohn’s disease: results of two phase 2b randomized placebo-controlled trials (DOP053, Friday, March 18, 18:54 - 19:01)

7. Tofacitinib pharmacokinetics and durability of drug exposure in moderate to severe Crohn’s disease patients in phase 2 induction and maintenance studies (P428, Friday, March 18, 12:20 - 13:20)

Baxter Enrolls First Patient in U.S. Clinical Trial for VIVIA Investigational Home Hemodialysis System

 

Baxter International Inc announced enrollment of the first patient in a U.S. clinical trial for VIVIA, an investigational home hemodialysis (HD) system being developed by Baxter and DEKA Research & Development Corporation.

The trial is designed to study more frequent, extended duration nocturnal home HD therapy (High Dose HD), which will be performed in dialysis facilities as well as the home setting. The study is assessing safety of the product and adequacy of dialysis.

The VIVIA investigational home hemodialysis system includes an integrated water purification module, safety sensors and one-button fluid infusion. The investigational system also features SHARESOURCE, Baxter’s two-way connectivity platform that allows physicians and nurses to monitor patients’ historical treatment results remotely.

GSK seeking Expanded Indication for FluLaval Quadrivalent in US

GSK announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for FLULAVAL^® QUADRIVALENT (Influenza Vaccine). This vaccine is currently approved for active immunisation against influenza A subtype viruses and type B viruses, in persons three years of age and older.  The submission seeks an expanded indication for children six months through 35 months of age. With this approval, providers would be able to use the same dose of FLULAVAL^® QUADRIVALENT (15 ug of hemagglutinin per virus strain in 0.5 mL) to cover all eligible persons from six months and up.

The sBLA application is based on one Phase III pivotal study and three supportive clinical studies conducted in children six months through 35 months of age.

FluLaval^® Quadrivalent was first approved in 2013 in the U.S. for the prevention of influenza disease in people three years of age and older. In addition, it is also approved in two other countries, Canada (as FluLaval^® Tetra) and Mexico (as FluZactal^® Tetra), for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine in people six months of age and older.

Novartis announces efficacy of Cosentyx in ankylosing spondylitis patients

Novartis announced that the results of the MEASURE 1 and MEASURE 2 Phase III studies for Cosentyx® (secukinumab) in ankylosing spondylitis (AS) were published in the New England Journal of Medicine (NEJM). These pivotal studies demonstrated significant clinical improvements with Cosentyx versus placebo in the signs and symptoms of active AS - a long-term, painful and debilitating inflammation of the spine. Collectively the studies form the largest clinical trial program ever conducted in AS, involving 590 patients.

 

In both studies, the primary endpoint was the proportion of patients with at least 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) response criteria at week 16 with Cosentyx 150 mg. ASAS 20 response rates with Cosentyx 150 mg vs placebo at Week 16 were 60.8% (vs 28.7%, p<0.001) for MEASURE 1 and 61.1% (vs 28.4%, p<0.001) for MEASURE 2[2]. The studies enrolled anti-tumor necrosis factor (anti-TNF) naïve patients and patients who had previously failed anti-TNF therapy, with clinical benefits demonstrated across the trial populations.

Clinical improvements were seen as early as Week 1 and were sustained throughout the studies, with up to 77% of patients achieving an ASAS 20 response at the end of Week 52. Efficacy assessments, except those at Week 16, were exploratory endpoints.

Cosentyx is the first IL-17A inhibitor to demonstrate efficacy in Phase III AS studies and was recently approved in Europe to treat active AS in adults who have responded inadequately to conventional therapy, such as non-steroidal anti-inflammatory drugs (NSAIDs). New treatment options are needed for patients who do not achieve an adequate response to NSAIDs or anti-TNFs, with up to 40% of patients not responding sufficiently to the latter.

GeNeuro Launches Phase IIb study “CHANGE-MS”

GeNeuro SA, a pioneer of new therapies for neurology and autoimmune disorders, announced that it has initiated its planned Phase IIb study “CHANGE-MS” (Clinical trial assessing the HERV-W Env ANtagonist GNbAC1 for Efficacy in Multiple Sclerosis) with its lead antibody GNbAC1 in Relapsing-Remitting Multiple Sclerosis (RRMS). The study plans to enroll 260 patients in 68 clinical centers in the European Union and Eastern Europe. Preliminary results are expected by the end of 2017.

The aim of the Phase IIb study is to demonstrate on RRMS patients the clinical benefit of GNbAC1 in neutralizing the MSRV-Env protein, which has been identified as a potential key factor fueling the inflammatory and neurodegenerative components of MS. Efficacy will be based on multiple brain magnetic resonance imaging scans, with an initial endpoint analysis after 6 months followed by a 6-month extension. By targeting MSRV-Env, GeNeuro aims to bring to patients a safe and effective treatment for both relapsing-remitting and progressive forms of the disease without hampering the patient’s immune system.

GeNeuro was created in 2006 by Eclosion, the Geneva life sciences accelerator, as a spin-off of Institut Mérieux of France. It develops first-in-class therapies against diseases associated with the expression of pathogenic proteins of human endogenous retroviral origin (HERV). GeNeuro’s lead product, GNbAC1, is a therapeutic antibody that targets MSRV-Env, a protein expressed in Multiple Sclerosis (MS) lesions from an early stage, which has been shown to be both pro-inflammatory and an inhibitor of remyelination, the two major drivers of MS progression.

The Multiple Sclerosis associated retrovirus (MSRV) is normally latent in the genome of individuals, but it can be re-activated by viral infections and other co-factors to express a pathogenic protein, MSRV-Env. MSRV-Env provides a missing link between the observation that viral infections are associated with the onset of the disease and expression of the pathogenic factor (the MSRV-Env protein), which can then explain the inflammatory and demyelinating characteristics of MS.

Novo Nordisk completes fourth phase 3a trial with semaglutide

Novo Nordisk announced the headline results from the fourth phase 3a trial for semaglutide, SUSTAIN2. Semaglutide is a new GLP-1 analogue administered subcutaneously once weekly. The double-blinded trial investigated the efficacy and safety of 0.5 mg and 1.0 mg semaglutide compared with 100 mg sitagliptin, a once-daily DPP-IV inhibitor, after 56 weeks of treatment in 1,231 people with type 2 diabetes, where both drugs were added on to metformin, thiazolidinedione (TZD) or a combination of metformin/TZD. 

The trial successfully achieved its objective by demonstrating that from a mean baseline HbA1c of 8.1%, people treated with 0.5 mg or 1.0 mg semaglutide achieved a statistically significant and superior improvement in HbA1c of 1.3% and 1.6% respectively, compared to an improvement in HbA1cof 0.5% with 100 mg sitagliptin.

69% of the people treated with 0.5 mg semaglutide and 78% of the people treated with 1.0 mg semaglutide achieved the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) treatment target of HbA1c below 7% compared with 36% of the people treated with 100 mg sitagliptin.

Furthermore, from a mean baseline body weight of 89 kg, people treated with 0.5 mg and 1.0 mg semaglutide experienced a statistically significant and superior weight loss of 4.3 kg and 6.1 kg respectively, compared with a weight loss of 1.9 kg for people treated with 100 mg sitagliptin.

In the trial, semaglutide appeared to have a safe and well-tolerated profile. The most common adverse event was nausea which diminished over time. Nausea was reported by 18% of the people treated with 0.5 mg semaglutide and by 18% of the people treated with 1.0 mg semaglutide, compared with 7% of people treated with 100 mg sitagliptin. The discontinuation rate due to adverse events was 8% and 10% for people treated with 0.5 mg semaglutide and 1.0 mg semaglutide respectively, compared to 3% for people treated with 100 mg sitagliptin.

Boehringer Ingelheim Started safety of OFEV Study

Boehringer Ingelheim announces the initiation of clinical trial, a new 12 week study to assess the safety, tolerability and pharmacokinetics of add-on treatment with pirfenidone to background therapy with OFEV in patients with idiopathic pulmonary fibrosis (IPF). The trial’s primary endpoint is the percentage of patients with on-treatment gastrointestinal (GI) adverse events from baseline to week 12.

IPF is a rare condition that causes thickening and scarring of the lung tissue over time, a process known as fibrosis. This fibrosis limits the amount of oxygen that can be delivered to the major organs and also causes difficulty breathing. The median survival of IPF patients following diagnosis is just 2-3 years, underlining the importance of early and accurate diagnosis and the vital role of treatments that can help to slow disease progression.

Merck Decides Not to Pursue Evofosfamide

Merck  announced that it is not planning to file for approval of evofosfamide in advanced soft tissue sarcoma and advanced pancreatic adenocarcinoma. The decision was made in light of the results from two Phase III studies of evofosfamide in combination with chemotherapy in these two types of cancer, as reported by Threshold Pharmaceuticals Inc. today. Merck will now be redeploying its resources into high-profile future products, such as avelumab* and all other priority programs in oncology, immuno-oncology and immunology.

Merck’s pharmaceutical pipeline is focusing on oncology, immuno-oncology and immunology. In immuno-oncology, Merck, together with Pfizer, is researching avelumab, an investigational anti-PD-L1 antibody, in more than 15 tumor types.

Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug of a bis-alkylating agent that is preferentially activated under severe tumor hypoxic conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

AbbVie released PHASE 1 Clinical Data of VENETOCLAX

AbbVie announced the online publication of new data in the New England Journal of Medicine (NEJM) showing some patients with relapsed/refractory chronic lymphocytic leukemia (CLL) treated with venetoclax experienced a response, including complete responses. The article reports data from Arm A of the study, in which all patients had relapsed CLL and more than one-third were refractory to their last treatment. Venetoclax is an investigational, first-in-class, B-cell lymphoma-2 (BCL-2) inhibitor being developed and commercialized by AbbVie and Genentech and Roche.

In arm A of the M12-175 study, venetoclax had an overall response rate of 79 percent (n=92/116) and complete response in 20 percent of patients. Serious adverse events (AEs) occurring in ≥ 2 percent of patients were febrile neutropenia, pneumonia, immune thrombocytopenia, tumor lysis syndrome, diarrhea, fluid overload, hyperglycemia, prostate cancer, pyrexia, upper respiratory tract infection, and viral upper respiratory tract infection. Grade 3 or 4 AEs occurring in ≥ 2 percentof patients were diarrhea, nausea, neutropenia, fatigue, anemia, thrombocytopenia, vomiting and hyperglycemia.

CLL is a typically slow-progressing cancer of the bone marrow and blood in which the bone marrow makes too many lymphocytes, a type of white blood cell.  Approximately 3-10 percent of CLL patients have 17p deletion at diagnosis. The 17p deletion mutation is a genomic alteration in which a part of chromosome 17 is absent.

Venetoclax is an investigational oral BCL-2 inhibitor being evaluated for the treatment of patients with various cancer types. The BCL-2 protein prevents apoptosis of some cells, including lymphocytes, and can be over expressed in some cancer types. Venetoclax is designed to selectively inhibit the function of the BCL-2 protein. Venetoclax is being developed in collaboration with Genentech and Roche. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory CLL, along with studies in several other cancers. Venetoclax is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.

EISAI TO PRESENT LATEST DATA ON FYCOMPA

Eisai Co., Ltd announced that the latest data on its in-house developed AMPA receptor antagonist Fycompa® (perampanel hydrate, “perampanel”) will be presented at the 69th American Epilepsy Society (AES) Annual Meeting to be held from December 4 to 8 in Philadelphia in the United States.

For this year's AES meeting, poster presentations will be given on 22 abstracts with highlights including additional and pooled analyses on the results of global Phase III clinical studies on primary generalized tonic-clonic (PGTC) seizures in patients with generalized epilepsy (Study 332) and on partial-onset epilepsy (Study 304, Study 305, Study 306), as well as the results of a Phase III clinical study on partial-onset epilepsy conducted in Asia including Japan. Furthermore, the overall results of Study 332, Study 304 and Study 306 were published in the major scientific journal Neurology, while the overall results of Study 305 were published in the specialist epilepsy journal Epilepsia.

Perampanel is a first-in-class antiepileptic drug (AED) discovered and developed by Eisai. With epileptic seizures being primarily mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.

Allergan and Gedeon Richter Plc. to Present Data on VRAYLAR

Allergan plc and Gedeon Richter Plc. announced they will present data on VRAYLAR (cariprazine) in patients with schizophrenia during the 54^th  American College of Neuropsychopharmacology (ACNP) Annual Meeting.

Data to be presented include additional analyses of cariprazine for the potential treatment of predominant negative symptoms in patients with schizophrenia. Also presented will be data investigating the metabolic safety profile of cariprazine and its impact on long-term schizophrenia relapse prevention.   

VRAYLAR is an oral, once daily atypical antipsychotic approved for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder, with a recommended dose range of 3 to 6 mg/day and for the treatment of schizophrenia in adults, with a recommended dose range of 1.5 to 6 mg/day. The safety and efficacy of VRAYLAR was studied in a clinical trial program of more than 2,700 patients with these conditions.

 Vraylar acts as a partial agonist at the dopamine D₃ and D₂ receptors. At antipsychotic doses, Vraylar shows high brain occupancy of  both D₃ and D₂  receptors in schizophrenia patients. Vraylar is also a high affinity partial agonist at serotonin 5-HT_1A receptors. In addition, Vraylar acts as an antagonist with high affinity at 5-HT_2B receptors and moderate affinity at 5-HT_2A and histamine H₁ receptors . Vraylar shows lower binding affinity to the serotonin 5-HT_2C and α_1A- adrenergic receptors and has no appreciable affinity for cholinergic muscarinic receptors. VRAYLAR was discovered and co-developed by Gedeon Richter Plc and is licensed to Actavis, now Allergan, in the U.S. and Canada.

Astellas and Ironwood Present Top - Line Data from Phase III IBS - C Trial

Astellas Pharma and Ironwood Pharmaceuticals announced that the Phase III clinical trial of Linaclotide conducted in Japan in adults with irritable bowel syndrome with constipation met its primary endpoints. Astellas expects to submit a New Drug Application to Ministry of Health, Labor and Welfare in Japan in 2016.

Linaclotide is a guanylate cyclase-C agonist currently approved in the United States for the treatment of adults with IBS-C and chronic idiopathic constipation. It is also approved for adults with IBS-C or CIC in more than 30 other countries.

For more details visit: PHASE III OF IBS-C TRIAL

Novartis presents new data on advanced breast cancer

Novartis will present data that highlight advancements in targeted combination therapy research, and underscore the company's continued commitment to bringing innovative treatments to patients living with advanced breast cancer at the 2015 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), December 8-12. Novartis will present 55 abstracts showcasing key real-world data from Afinitor® (everolimus), Tykerb® (lapatinib) and several investigational compounds in advanced breast cancer.

Because BKM120 (buparlisib), LEE011 (ribociclib), BYL719 (alpelisib) and LA-EP2006 are investigational compounds, the safety and efficacy profiles have not yet been fully established. Access to these investigational compounds is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the compound. Because of the uncertainty of the outcome/results of the clinical trials, there is no guarantee that BKM120, LEE011, BYL719 and LA-EP2006 will ever be commercially available anywhere in the world.

Amgen to Present IMLYGIC Data

Amgen announced that the Company will present eight IMLYGIC (talimogene laherparepvec) abstracts, including data from the Phase 3 trial and new data from its Phase 1b combination trial with Merck's anti-PD-1 therapy, at the 12^th International Congress of the Society for Melanoma Research (SMR), to be held on Nov. 18-21 in San Francisco. 

The Phase 1b data on IMLYGIC in combination with an investigational use of Merck's anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), in patients with unresectable metastatic melanoma has been accepted as a late-breaking abstract.

IMLYGIC is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. IMLYGIC replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. IMLYGIC then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response. However, the exact mechanism of action is unknown.

 

IMLYGIC is the first oncolytic viral therapy approved by the FDA based on therapeutic benefit demonstrated in a pivotal study. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.

AbbVie Announces Phase 2 Studies ABT-493

AbbVie announced data from the SURVEYOR studies of its investigational HCV regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, that show high rates of sustained virologic response at 12 weeks post-treatment (SVR₁₂) in non-cirrhotic patients with chronic hepatitis C virus (HCV) infection. After 12 weeks of treatment, SVR₁₂ rates achieved were 97-100 percent in genotype 1 (GT1), 96-100 percent in genotype 2 (GT2) and 83-94 percent in genotype 3 (GT3) patients.These data are being presented at The Liver Meeting^® 2015, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco. 

Separately, in a late-breaking presentation of the SURVEYOR-I study, data show non-cirrhotic GT1 chronic HCV patients who received a shorter duration of treatment for 8 weeks with ABT-493 and ABT-530 achieved a SVR₁₂ rate of 97 percent.

^{SURVEYOR-I and SURVEYOR-II are ongoing Phase 2 clinical studies that evaluate the safety and efficacy of ABT-493 and ABT-530, with or without ribavirin (RBV), for 8 to 12 weeks. These data presented at AASLD include non-cirrhotic patients with GT1, GT2 and GT3 chronic HCV infection. Data in additional patient populations (genotypes 4-6) will be presented at future meetings.} 

GSK announces positive results of Benlysta

GSK announced results from the BLISS-SC Phase III pivotal study in patients with active, autoantibody-positive systemic lupus erythematosus (SLE). These results, which are being presented at the American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting, showed that Benlysta^® (belimumab) 200mg administered weekly via subcutaneous injection plus standard of care (SoC), showed significantly greater reductions in disease activity compared to placebo plus SoC.

BLISS-SC builds on a robust clinical trial programme for belimumab, which is the largest conducted in SLE to date. BLISS-SC is a Phase III, multi-centre, randomised, double-blind, placebo-controlled, 52-week study to evaluate the efficacy and safety of belimumab administered subcutaneously to patients with active, autoantibody-positive SLE who are receiving standard therapy. The primary efficacy endpoint is the SRI response rate at Week 52.

Benlysta is the first medicine specifically developed and approved for SLE in over 50 years. It is a human monoclonal antibody that selectively targets B-lymphocyte stimulator (BLyS), an important factor in the survival of B cells

Pfizer to Present New Data on Eliquis

Bristol Myers Squibb and Pfizer announced that 22 abstracts will be presented at the American Heart Association (AHA) Scientific Sessions 2015, to be held November 7-11 in Orlando, Florida. The new data, including four oral presentations, contribute to the Bristol-Myers Squibb and Pfizer Alliance’s research in nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE) in patients treated with Eliquis. Abstracts include new data analyses from the pivotal Phase 3 study, ARISTOTLE, as well as a number of real-world data analyses.

Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquisdecreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the U.S. based on efficacy and safety data from seven Phase 3 clinical trials. Eliquis is a prescription medicine indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF); for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE, following initial therapy.

Novartis presents new two year data for Cosentyx

Novartis announced new results for Cosentyx^® (secukinumab) showing no further progression in joint damage in 84% of patients with psoriatic arthritis (PsA). In addition, Cosentyx maintained a treatment response in joint and skin disease, physical function and quality of life in patients over two years of treatment. These results from the extension phase of the FUTURE 1 study were presented at the 2015 Annual Meeting of the American College of Rheumatology (ACR) in San Francisco, United States. Cosentyx is the first of a new class of medicines called interleukin-17A (IL-17A) inhibitors to demonstrate efficacy in Phase III studies in PsA - a life-long inflammatory disease that affects the skin and joints. If not treated effectively, it can lead to irreversible joint damage and disability caused by years of inflammation.

New medicines with an alternative way of working are needed as many patients do not achieve an adequate response from current treatments, such as disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatories or anti-tumor necrosis factor (anti-TNF) therapies. Many patients do not respond to or tolerate these therapies, with approximately 45% of PsA patients dissatisfied with their treatments.

ViiV Healthcare announces Results of HIV drug Regimen

ViiV Healthcare announced that the Phase IIb study LATTE 2 (NCT02120352) met its primary endpoint at 32 weeks.  These results show that the investigational, long acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) were comparable in maintaining viral suppression rates to a three drug oral regimen of investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs). The 32 week results of LATTE 2 will be presented at a forthcoming scientific conference. ViiV Healthcare and Janssen Sciences Ireland UC (Janssen) are collaborating to conduct LATTE 2.

Viral suppression rates (plasma HIV-1 RNA <50 c/ml by FDA snapshot analysis) for patients at 32 weeks receiving two drug maintenance therapy with investigational long acting cabotegravir (CAB LA) and long acting rilpivirine (RPV LA) dosed every 8 weeks (Q8W, 95%) or every 4 weeks (Q4W, 94%) were comparable to the rate observed in patients continuing with a three drug oral regimen of investigational CAB + NRTIs (91%).

Patients switching to CAB LA and RPV LA administered Q4W reported more adverse events (AEs) leading to withdrawal (5%; n=6) compared with those receiving an injection Q8W (2%; n=2) or who continued on oral CAB + NRTIs (2%, n=1). The most common adverse event (AE) reported by patients was injection site pain (93% of injection recipients). Two patients in the Q8W arm (none in the Q4W arm) withdrew for injection intolerance. Two patients met protocol defined virologic failure criteria, Q8W (n=1), oral (n=1); neither patient had evidence of resistance at failure.

Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and analogue of dolutegravir (Tivicay®). Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV and is currently being evaluated as a once-daily oral tablet formulation and as a LA nanosuspension formulation for intramuscular (IM) injection.

Rilpivirine is a once daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of human immunodeficiency virus (HIV‑1) infection in combination with other antiretroviral agents in antiretroviral treatment-naïve adult patients with a viral load ≤ 100,000 HIV RNA copies/mL. Rilpivirine was developed by Janssen. Rilpivirine is approved in US and EU as EDURANT® as a single agent tablet dosed at 25mg taken once a day. The overall safety profile of rilpivirine is based on Phase III clinical studies. Rilpivirine is also available in the United States (US) and the European Union as part of a once daily fixed dose antiretroviral combination with Gilead Sciences Inc’s tenofovir and emtricitabine. This combination, known as COMPLERA® (US) or EVIPLERA®.