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NEW HAVEN, Conn., July 11, 2019 / PRNewswire / – Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced the presentation of 16 scientific presentations (oral and poster) highlighting new data on the efficacy and safety of rimegepant from the clinical development program developed by Biohaven at the American Headache Society AHS) Annual Scientific Meeting at Philadelphia cream, July 11-14, 2019. Biohaven will present the results of the Rimegepant Zydis® rapid oral dissolution (ODT) phase 3 trial, new badyzes of the three phase 3 trials, the results of the long-term safety study. term of rhyme and new clinical pharmacology data. Rimegepant is an oral, single-dose, selective and potent oral calcitonin gene-binding peptide (CGRP) receptor antagonist for the acute treatment of migraine.
"Through 16 presentations at AHS, the first annual National Headache Conference, we share the most comprehensive positive data set on rhimegepant as an acute treatment for migraine," he said. Vlad Coric, M.D., General Manager of Biohaven. "These studies demonstrate that rimegepant is effective for the acute treatment of migraine in several subgroups of patients, including those patients who are difficult to treat with more frequent seizures and those who simultaneously take migraine preventive medications, as well as patients suffering from nausea. "
Richard Lipton, MD, Professor and Vice President of the Department of Neurology, Albert Einstein College of Medicine and Montefiore Health System, Director of the Montefiore Headache Treatment Center, to Present Positive Results of Controlled Phase 3 Clinical Trial and Randomized Trial (Study 303) Evaluating the Efficacy and Safety of Zydis ODD Rimegepant for the Acute Treatment of Migraine on Saturday, July 13 of 8:40 am – 8:50 ET (Oral presentation # IOR05). Dr. Lipton is also a paid consultant and shareholder of Biohaven.
In accordance with the two Phase 3 clinical trials conducted on the oral rimegepant tablet, Study 303 met its primary endpoints: absence of pain and absence of the most troublesome symptom after two hours with a single dose. Importantly, patients treated with the Zydis ODT rimegepant formulation began to experience pain relief by 15 minutes, with a digital separation from placebo, and this difference was statistically significant at 60 minutes (p = 0.0314). In addition, a significantly higher percentage of patients treated with Zydis ODT rimegepant returned to normal function in 60 minutes compared to placebo (p = 0.0025). In addition, a sustained clinical benefit was observed 48 hours after a single dose of rhymepant on the absence of pain (p <0.0001), pain relief (p <0.0001), l-39 the absence of the most troublesome symptom (p = 0.0018) and the absence of handicap (p <0.0001). The superiority over placebo was also demonstrated on other secondary clinical endpoints. The vast majority of patients treated with Rimegepant Zydis ODT (85%) did not use any rescue medication.
"Results from the Zydis ODT Rimegepant Phase 3 Study for the Acute Treatment of Migraine Demonstrate the Significant Benefits of this Easy-to-Use Single-Dose Formulation, with Early and Sustained Symptom Relief, Low Use emergency medications and low energy consumption, adverse event rates, "said Dr. Lipton. "A new, effective, safe and convenient short-course treatment option would be a big step forward for the millions of people around the world whose migraines have an impact on everyday life."
A total of 15 additional rhymepant posters were presented to AHS. Posters include:
- Poster No. P235LB: Provisional Results from the Long-Term Open-Ended Safety Study of Rimegepant 75 mg in More than 1780 Patients with a Combined Exposure of More Than 105,000 Doses Presented for the First Time at a Meeting scientist. Patients received a dose of up to one year and were allowed to take rhimegepant at most once a day. The drug was well tolerated in adult migraine patients, only 2.7% of subjects discontinued treatment due to an adverse event and there was no evidence of hepatotoxicity. A cohort receiving regular 75 mg rimegespant at a high frequency at least every two days showed consistent results for the general population. The exploratory efficacy badyzes in this study demonstrate that rimegepant reduces migraine days when used as needed for acute seizure treatment, as well as when it is administered on a scheduled basis, suggesting that rhimegepant may have an action in double therapy with acute and preventive effects of treatment. .
- Poster No. P239LB: A pooled badysis of the results of the three phase 3 trials of rimegepant examined the efficacy of rimegepant in patients taking concomitant preventive therapy and showed that rimegepant was more effective than placebo for the acute treatment of headache. Among the subjects on preventive medication (547 subjects, rhyming n = 272, placebo n = 275), the pain relief rates grouped over two hours for rhyme and placebo were 20.6% and 10.2%, respectively. (p = 0.0007). In addition, the rates of absence of the most troublesome symptom over two hours were 37.1% for rhymepant and 20.4% for placebo (p <0.0001).
- Poster No. P236LB: A pooled badysis of the results of the three phase 3 trials of rimegepant examined the efficacy of rimegepant in patients with a high frequency of migraine attacks (at least four seizures per month), a patient population of which has already been shown to be more difficult. Rimegepant was an effective treatment for acute migraine. Among subjects with at least 4 moderate or severe attacks per month (2426 subjects, rhyming n = 1217, placebo n = 1209), the two-hour pain relief rates for rimegepant and placebo were 20.6 % and 12.6% (p <0.0001). For a two-hour absence of the most troublesome symptom, the rates were respectively 35.8% and 26.9% for rhymepant and placebo (p <0.0001).
- Poster No. P238LB: The First Clinical Report Evaluating the Efficacy and Safety of Rimegepant in the Acute Treatment of Migraine for Breakthrough Attacks in Two Patients Simultaneously Receiving Erenumab, a Monoclonal Antibody binding to the CGRP receptor, was presented for the first time in a scientific meeting. Both patients were included in the long-term and open-ended safety study of rimegepant. With the rhimegepant used in short-term treatment, both patients were able to eliminate the use of additional rescue medications and successfully treat their attacks with rimegepant alone. After the start of the preventive treatment with erenumab, both patients were able to successfully treat breakthrough attacks with oral rhymepant despite the use of preventive treatment with injectable monoclonal antibody.
About Rimegepant
Rimegepant is the oral calcitonin gene-linked peptide receptor (CGRP) antagonist, which the Company is currently developing for the treatment of migraine. Rimegepant represents a new mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. The efficacy and safety profile of rimegepant for the treatment of acute migraine has now been established in four randomized controlled trials to date: the three pivotal phase 3 trials completed and a phase 3 trial. 2b trial. The common endpoints obtained in the three Phase 3 trials comply with the FDA's regulatory guidelines for NDA submissions that form the basis for NDA submissions to the FDA.
About Biohaven
Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative and advanced product candidates for neurological diseases, including rare diseases. Biohaven has combined in-house development and research with intellectual property licensed by companies and institutions such as Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and Mbadachusetts General Hospital. Currently, Biohaven's major development programs include several compounds among its CGRP receptor antagonist platforms, glutamate modulation, and myeloperoxidase inhibition. More information on Biohaven is available at www.biohavenpharma.com.
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, 1995. All statements, other than statements of historical fact, contained in this news release regarding the Company's plans and objectives with respect to the business and product candidates are forward-looking statements. Forward-looking statements include but are not limited to: the effectiveness and safety of the rhyme, the timing, the commencement and results of the Company's planned and ongoing clinical trials, the timing of interactions and filings with the FDA , the timing and results of regulatory activities, deposits, the potential commercialization of the Company's product candidates, and the potential for the company's product candidates to be first clbad or best-in-clbad. The use of certain words, such as "believe", "continue", "may", "on the right track", "expect" and "go", and other similar expressions, is intended to identify forward-looking statements. A number of important factors may cause actual results or events to differ materially from those expressed or implied by our forward-looking statements. Other important factors to consider in the forward-looking statements are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019 and the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, filed with the Securities and Exchange Commission on May 8, 2019. Forward – looking statements are made as of such date and the Company badumes no obligation to update such statements, whether as a result of new information, future events or otherwise, except as provided by law. required.
For more information, contact:
Dr. Vlad Coric
General manager
[email protected]
For Media:
Mike Beyer
Sam Brown Inc.
[email protected]
312-961-2502
SOURCE Biohaven Pharmaceutical Holding Company Ltd.
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http://biohavenpharma.com
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