Aurinia Pharmaceuticals Completes Analysis of First Seven Patients in AURION Study in LN- Aurinia Pharmaceuticals (AUPH) announced that it has completed an analysis of the first 7 patients to complete 24 weeks in its open-label AURION study. At 24 weeks 57% (n=4/7) of patients continued to be in complete remission as measured by a urinary protein creatinine ratio of ≤ 0.5mg/mg, eGFR within 20% of baseline and concomitant steroid dose of < 5mg/day.
Galena Tumbles After Late Stage Study of NeuVax Discontinued- Galena BioPharma (GALE) shares dropped more than 80% on Wednesday after the company announced that it has discontinued its Phase 3 PRESENT Study evaluating NeuVax (nelipepimut-S) to prevent breast cancer recurrence in the adjuvant setting. The decision was taken based on recommendation from the Independent Data Monitoring Committee. An interim analysis of 71 qualifying disease-free survival events failed to show a significant effect from treatment with NeuVax. The trial remains blinded. The company says it will host a conference call next week after evaluating the data.
Omeros Announces Completion of Patient Enrollment in Pediatric Trial of OMIDRIA- Omeros Corporation (OMER) announced that it has completed enrollment in the post-marketing pediatric clinical trial that is expected to provide extended market exclusivity of its commercial product OMIDRIA (phenylephrine and ketorolac) 1% / 0.3%. The successful completion of the study will add an additional six months of marketing exclusivity. The FDA has approved OMIDRIA for use in adult patients undergoing cataract or intraocular lens replacement surgery to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain.
Shire Reports Encouraging Data for SHP465- Shire (SHPG) shares rose more than 5% on Wednesday after the company announced top-line results from a Phase 3 clinical trial called study 306 evaluating its investigational SHP465 for the treatment of symptoms of attention-deficit/ hyperactivity disorder (ADHD) in adults showed a significant treatment benefit compared to placebo. The study met its primary endpoints for both doses (12.5 mg and 37.5 mg) administered once daily. Specifically, SHP465 was superior to placebo as measured by the change from baseline to week 4 in a rating scale called ADHD-RS. It was also superior to placebo on a key secondary endpoint measured by the clinical global impression improvement scale (CGI-I) at week 4. Shire plans to file a Class 2 resubmission of its New Drug Application (NDA) with the FDA by the end of the year. If all goes well, approval should happen in H2 2017. It has been a long haul. The NDA was originally filed in July 2006.
Actinium Initiates Phase 3 SIERRA Trial- Actinium Pharmaceuticals (ATNM) announced that a pivotal Phase 3 clinical trial, SIERRA, for its lead product candidate Iomab-B has been initiated. Iomab-B is intended to be an induction and conditioning agent used to prepare patients with relapsed or refractory acute myeloid leukemia (AML) who are over the age of 55 for a hematopoietic stem cell transplant (HSCT), commonly referred to as bone marrow transplant (BMT). There are currently no effective treatments for this patient population.
Horizon Submits sNDA for RAVICTI- Horizon Pharma (HZNP) announced that it has submitted a supplemental New Drug Application (sNDA) with the FDA for RAVICTI (glycerol phenylbutyrate) Oral Liquid to expand the age range for chronic management of urea cycle disorders (UCDs) in adult and pediatric patients from two years of age to two months of age and older. RAVICTI is currently indicated for use as a nitrogen-binding agent for chronic management of adult and pediatric patients greater than two years of age with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
Cara Commences Phase 2/3 Study of Lead Product Candidate- Cara Therapeutics (CARA) announced that it has initiated a Phase 2/3 clinical trial evaluating its lead product candidate CR845 for the treatment of moderate-to-severe uremic pruritus (UP) in dialysis patients. UP is a persistent itch condition associated with chronic kidney failure that affects up to half of patients. There are no approved therapies in the U.S. for the condition. The Phase 2 stage will randomize 160 patients to receive one of three doses of intravenously administered CR845 (0.5 mcg/kg, 1.0 mcg/kg or 1.5 mcg/kg) or placebo three times per week for eight weeks. The Phase 3 stage will randomize up to 240 patients to receive one optimized dose of IV CR845 or placebo three times per week for 12 weeks. Primary and secondary endpoints will include itch intensity and quality-of-life measures associated with pruritus burden.