Biohaven Pharmaceutical announced positive results from a double-blind, placebo-controlled, proof of concept clinical trial evaluating the effect of BHV-0223 in patients diagnosed with social anxiety disorder and public speaking anxiety while performing an anxiety-provoking speech task. BHV-0223 met its primary endpoint of improvement in anxiety compared to placebo during an anxiety-provoking speech task in patients diagnosed with social anxiety disorder and public speaking anxiety. The investigator-initiated trial was performed at Yale University School of Medicine and treated 21 subjects who had a diagnosis of social anxiety disorder and participated in an anxiety-provoking, speech task in a double-blind, crossover design. In the pre-specified, primary analysis, BHV-0223 reduced anxiety by 8.3 points relative to placebo on the 100-point Visual Analogue Scale, or VAS. The observed reduction in anxiety was significant, relative to the protocol specified level. A likelihood-based analysis, that analyzed the change in the VAS from the pre-speech baseline, found that BHV-0223 had a 14.4-point advantage relative to placebo. In addition, BHV-0223 was safe and well-tolerated during this study. Biohaven expects to present additional results from this trial at upcoming scientific meetings over the next year. Based upon these trial results, Biohaven plans to expand its glutamate modulating platform development program to include the treatment of GAD. The trial results support further development of Biohaven’s glutamate modulating platform as a potential novel treatment for anxiety disorders. Biohaven has an exclusive license agreement with Yale University under Yale’s patent rights for the commercial development, manufacture, distribution, use and sale of products and methods related to the use of riluzole in treating a variety of central nervous system disorders including generalized anxiety disorder, social anxiety disorder and panic disorder. In addition to BHV-0223, Biohaven also owns worldwide patents and patent applications covering a broad library of prodrugs of riluzole designed for optimized safety, tolerability and pharmacokinetics.
Thursday, August 16, 2018
Medtronic’s ITB therapy for post-stroke spasticity shows positive results
Medtronic announced the online publication of results, secondary endpoints of the ‘Spasticity In Stroke-Randomised Study’, or SISTERS, trial, demonstrate Intrathecal Baclofen Therapy. or ITB Therapy, with Lioresal Intrathecal injection reduces spasticity-related pain and improves quality of life more than conventional medical management with oral antispastic medications. Spasticity, a condition where certain muscles are constantly being contracted, is a relatively common long-term complication of stroke. Results of the study show ITB was more effective than CMM over six months for actual and least spasticity-related pain. Further, a majority of ITB patients reported satisfaction with spasticity reduction at month 6. More patients reported adverse events in the ITB group – 24/25 patients, 96% – compared to CMM – 63 percent; 77 events -, although events were generally consistent with the known safety profile of ITB Therapy. No patient discontinued ITB Therapy due to treatment related adverse events.
Emergent and Profectus receive up to $36M to develop Lassa virus vaccine
Emergent BioSolutions and Profectus BioSciences announced a new collaboration with CEPI, the Coalition for Epidemic Preparedness Innovations, under which they will receive up to $36M to advance the development and manufacture of a vaccine against the Lassa virus-an estimated 100,000 to 300,000 cases of Lassa virus infection occur each year. Profectus will receive development funding from CEPI for advancing its Lassa virus vaccine. CEPI will provide $4.3M to support the first phase of the project, with options to invest up to a total of $36M over five years, including procurement of the vaccine for stockpiling purposes. Emergent will provide technical and manufacturing support for the CEPI-funded program. Through a separate agreement with Profectus, Emergent has an exclusive option to license and to assume control of development activities for the Lassa-virus vaccine from Profectus.
Zimmer Biomet initiated at BTIG
Zimmer Biomet initiated with a Neutral at BTIG. BTIG analyst Ryan Zimmerman initiated Zimmer Biomet with a Hold rating as part of his broader research note titled “Riding the Robotic Wave in Orthopedics”. The analyst notes that the company has been a leader in Orthopedics but is currently undergoing a turnaround under new management while an upgrade of one of its manufacturing facilities progresses. Zimmerman considers Zimmer’s revenue outlook for FY18 to be achievable, even though the two-year timeline for its turnaround may be impacted by delays in the manufacturing facility remediation as the company also addresses FDA expectations around its productivity gains.
NuVasive price target raised to $72 from $68 at BTIG
BTIG analyst Ryan Zimmerman raised his price target on NuVasive (NUVA) to $72 and kept his Buy rating following investor meetings with the management, saying the tone of the discussions was “decidedly more upbeat” after Q2 results and the company’s FY18 guidance cut. The analyst states that he also “underappreciated” the potential for NuVasive’s recent agreement with Siemens (SIEGY), as it expands the company’s opportunity and provides better commercial support. Zimmerman expects investor interest in NuVasive shares to build heading into the full launch of the company’s new Pulse system.
Teva, Regeneron: Phase 3 arthritis pain study met co-primary endpoints
Teva Pharmaceutical Industries (TEVA) and Regeneron Pharmaceuticals (REGN) announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis of the knee or hip. At the week 16 primary efficacy analysis, the study met both co-primary endpoints and all key secondary endpoints. Fasinumab-treated patients experienced significantly less pain and significantly improved functional ability from baseline compared to placebo. The study compared two different fasinumab treatment arms with placebo. After the primary efficacy assessment at week 16, patients continue on therapy for an additional 36 weeks, followed by a subsequent 20-week off study drug follow-up period for further safety assessment. Interim safety data indicate that fasinumab was generally well tolerated, with similar adverse events as those observed in previous fasinumab trials. At week 16, treatment discontinuations due to AEs had occurred in 6% of the placebo group patients, 5% of the fasinumab 1 mg every eight weeks group patients and 6% of the fasinumab 1 mg every four weeks group patients. The fasinumab safety program was designed to capture all arthropathies, including those identified due to symptoms and those identified by regularly-scheduled radiographic monitoring, the first of which was scheduled at week 24. Among the approximately 65% of patients who had completed their first radiographic assessment, the placebo-adjusted rate of adjudicated arthropathies was approximately 2%. The majority of arthropathies were captured by the regularly-scheduled radiographic monitoring and involved isolated joint space narrowing, called RPOA-1. No cases of osteonecrosis have been identified to date in this study. Regeneron and Teva are jointly developing fasinumab as part of a global collaboration agreement. In Japan and 10 other Asian countries, Mitsubishi Tanabe Pharma Corporation holds exclusive development and commercial rights for fasinumab. The Phase 3 study is a sub-study of a larger, long-term trial that involves 52 weeks of active treatment, designed to determine the safety and tolerability of fasinumab, including AEs of special interest, in patients with pain due to radiographically-confirmed OA of the knee or hip. Approximately 85% of sub-study patients had OA of the knee. The primary efficacy data were assessed at 16 weeks; the primary safety analysis of the larger long-term trial will occur at 72 weeks. The safety data presented today are interim data and preliminary in nature. Earlier this year, an Independent Data Monitoring Committee monitoring the safety and efficacy of ongoing fasinumab trials recommended that the two higher dose regimens be discontinued.
Invacare downgraded to Sector Weight after Q2 results at KeyBanc
KeyBanc analyst Matthew Mishan downgraded Invacare to Sector Weight from Overweight post Q2. The analyst believes its turnaround is not progressing as quickly as he hoped and rather than seeing some acceleration toward long-term targets, Mishan is again resetting his expectations lower. While stable with some positives, there are still headwinds constraining broader sales momentum, the analyst notes, adding that he is surprised there has not been more upside to margins given both restructuring activity and mix shift.
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