-Rimegepant leads the meeting with the most presentations for an oral small molecule CGRP receptor antagonist, including 14 late breakers
-Oral Presentation of rimegepant Zydis® Orally Dissolving Tablet (ODT) Phase 3 results for the acute treatment of migraine
-Phase 3 analyses examining efficacy of rimegepant regardless of migraine attack frequency and in patients taking concurrent preventive medications
-Interim safety analysis from long-term, open-label safety study of rimegepant
-First clinical reports evaluating acute treatment benefit of oral rimegepant in patients already being treated with injectable CGRP-targeting monoclonal antibodies for preventive therapy
NEW HAVEN, Conn., June 24, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (BHVN), today announced it will be presenting 16 abstracts, including new efficacy and safety analyses from the Phase 3 rimegepant studies along with other important clinical results, at the 2019 American Headache Society Annual Scientific Meeting in Philadelphia, July 11-14, 2019. Rimegepant is an oral, single dose, selective and potent small molecule calcitonin gene-related peptide (CGRP) receptor antagonist in development for the acute treatment of migraine. These 16 abstracts encompass the largest volume of presentations for an oral, small molecule CGRP receptor antagonist at this meeting.
"The extensive data set we are presenting at AHS showcases the potential of rimegepant, our lead oral CGRP product candidate, as a novel and differentiated acute treatment for migraine," said Vlad Coric, M.D., Chief Executive Officer of Biohaven.
Oral presentation details:
Presentation Title: Efficacy, Safety, and Tolerability of Rimegepant 75 mg Orally Dissolving Tablet for the Acute Treatment of Migraine: Results from a Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial, Study 303 (Presentation #IOR05)
Presentation Date: Saturday, July 13
Presentation Time: 8:40 am – 8:50 am
Poster presentation details:
All posters will be on display Thursday, July 11, 4:30 pm through Saturday, July 13, 5:00 pm.
The following posters will have a Q&A session on Friday, July 12, 1:15 pm – 2:15 pm:
Rimegepant 75 mg is Effective for the Acute Treatment of Migraine Regardless of Attack Frequency: Results From 3 Phase 3 Trials (Poster #P236LB)
Acute Treatment Benefit from Oral CGRP Receptor Antagonist and Monoclonal Antibody Combination: Rimegepant 75 mg for Acute Treatment of Attacks During Preventive Therapy With Erenumab (Poster #P238LB)
The Pharmacokinetics, Safety, and Tolerability of Rimegepant 75 mg are Similar in Elderly and Nonelderly Adults: A Phase 1, Open-Label, Parallel-Group, Single-Dose Study (Poster #P240LB)
A Single Dose of Rimegepant 75 mg Provides Pain Relief and Return to Normal Function: Results from 3 Phase 3 Trials in Adults With Migraine (Poster #P242LB)
A Single Dose of Rimegepant Demonstrates Sustained Efficacy and Low Rescue Medication Use in the Acute Treatment of Migraine: Results From 3 Phase 3 Trials (Poster #P244LB)
Rimegepant 75 mg Is More Effective Than Nonsteroidal Anti-inflammatory Drugs for the Acute Treatment of Migraine: Post Hoc Analysis of Data From 2 Phase 3 Trials (Poster #P246LB)
Phase 1 Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose Rimegepant as Compared to the Predicted Clinically Efficacious Dose Range (Poster #P280LB)
The following posters will have a Q&A session on Saturday, July 13, 1:00 pm – 2:15 pm:
Rimegepant 75 mg Demonstrates Superiority to Placebo on Nausea Freedom: Results from a Post Hoc Pooled Analysis of 3 Phase 3 Trials in the Acute Treatment of Migraine (Poster #P41)
Long-Term, Open-Label Safety Study of Rimegepant 75 mg for the Treatment of Migraine (Study 201): Interim Analysis of Safety and Exploratory Efficacy (Poster #P235LB)
Cardiovascular Safety of Rimegepant 75 mg in 3 Randomized Clinical Trials and Systematic Evaluations from In Vitro, Ex Vivo, and In Vivo Nonclinical Assays (Poster #P237LB)
Rimegepant is Effective for the Acute Treatment of Migraine in Subjects Taking Concurrent Preventive Medication: Results From 3 Phase 3 Trials (Poster #P239 LB)
Rimegepant 75 mg in Subjects with Hepatic Impairment: Results of a Phase 1, Open-label, Single-dose, Parallel-Group Study (Poster #P241LB)
The Safety and Tolerability of Rimegepant 75 mg Are Similar to Placebo: Results from 3 Phase 3 Trials in Adults With Migraine (Poster #P243LB)
Rimegepant Has No Clinically Relevant Effects on ECG Parameters: A Thorough QT Study Versus Placebo and Moxifloxacin in Healthy Subjects (Poster #P245LB)
Safety of Rimegepant 75 mg in Adults With Migraine: No Effects of Age, Sex, or Race in 3 Phase 3 Trials (Poster #P247LB)
Rimegepant is Biohaven's orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist, which the Company is developing as a treatment for migraine. Rimegepant represents a novel mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. The efficacy and safety profile of rimegepant for the acute treatment of migraine has now been established across four randomized controlled trials to date: the three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in all three Phase 3 trials are consistent with regulatory guidance from the FDA and form the basis of Biohaven's NDA submission to the FDA.
Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation and myeloperoxidase inhibition platforms. More information about Biohaven is available at www.biohavenpharma.com.
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the expected timing, commencement and outcomes of the Company's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the expected issuance of preferred stock to Royalty Pharma, the potential commercialization of the Company's product candidates and the potential for the Company's product candidates to be first in class or best in class therapies. The use of certain words, including "believe", "continue", "may", "on track", "expects" and "will" and similar expressions, are intended to identify forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with 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. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
For further information, contact Dr. Vlad Coric, Chief Executive Officer, at Vlad.Coric@biohavenpharma.com
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