NEW HAVEN, Conn., Sept. 9, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that it presented expanded data and post-hoc analyses from its long term clinical study (BHV3000-201) demonstrating clinically important benefits of rimegepant on migraine-specific disability and quality of life in the late breaking oral and poster sessions at the International Headache Conference in Dublin, Ireland.
Over 1,700 patients with migraine enrolled in this study. Disability and quality of life outcome measures were assessed at baseline and Weeks 12, 24, 36, and 52 using the Migraine Disability Assessment (MIDAS) and the Migraine-Specific Quality of Life Scale (MSQoL). Patients received rimegepant 75 mg as needed up to once daily for the acute treatment of migraine. This dose has been shown to produce statistically significant and clinically meaningful benefits in three positive phase 3 pivotal trials. These new analyses demonstrated improvements in migraine-related disability that were clinically important and statistically significant at all time points (p<.0001). Additionally, significant (p<.0001) improvements in absenteeism and presenteeism items were seen throughout treatment follow-up.
At baseline, the mean Total MIDAS Score was 33.8+0.8 (SE), reflecting a severely disabled level of functioning for the study population. Rimegepant demonstrated improvements in mean [95% C.I.] change from baseline for Total MIDAS Score across weeks 12 to 52: −12.5 [−13.93, −11.07] at Wk 12; −14.1 [−15.75, −12.51] at Wk 24; −14.8 [−16.59, −13.01] at Wk 36; and −14.0 [−15.93, −12.13] at Wk 52. Improvements in MIDAS scores were clinically important and statistically significant (P<.0001 versus baseline – all time points). MIDAS is a validated 5-item instrument that queries migraine-related absenteeism and lost productivity at work, school, and home, as well as missed family, social, and leisure activities.
Robert Croop, M.D., Biohaven's Chief Development Officer – Neurology stated, "Acute treatment of migraine with rimegepant over the one-year treatment period decreased disability by approximately 41% as measured by the MIDAS questionnaire reflecting improved patient outcomes in this study. We believe that effective and well-tolerated oral acute therapies for migraine will help patients return to their lives and improve long-term outcomes."
The Migraine Specific Quality of Life (MsQOL, v2.1) is a validated 14-item scale designed to measure how migraine affects and/or limits daily functioning across three domains: two domains assessing how migraine prevents activities (Role-Restrictive [RR]; Role Preventative [RP]), and one domain assessing the emotional impact of migraine (Emotional Role [ER]). Mean MSQoL scores at baseline were 52.7 for RR, 67.9 for RP and 60.9 for ER, illustrating substantive negative impact of migraine on patients. By Wk 12, rimegepant-treated subjects showed clinically and statistically significant improvements: mean change from baseline of +14.5, +11.5, and +15.4, for RR, RP, and ER respectively, (p<0.0001). These benefits were sustained at Wk 24: +15.4,+12.8,+15.8 (p<0.0001), Wk 36: +17.4,+13.7+17.0, (p<0.0001), and Wk 52: +17.6, +14.4, +17.2, (p<0.0001) for RR, RP, and ER respectively.
Gil L'Italien, Ph.D., Head of Global Health Economics Outcomes Research & Epidemiology at Biohaven stated, "These compelling findings, showing sustained improvements in both migraine-specific disability and quality of life, suggest an added long-term benefit of rimegepant that derives from the effective acute treatment of migraine. Both disability and quality of life improvements exceeded the minimum clinically important difference by more than two-fold. These benefits have important implications for reducing health care costs, improving workplace productivity, and overall enhanced patient wellbeing."
About Rimegepant and Study BHV3000-201
Rimegepant is Biohaven's orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist, which the Company is developing as a treatment for migraine. The Company submitted New Drug Applications ("NDAs") with the U.S. Food and Drug Administration (the "FDA") in the second quarter of this year and has disclosed filing acceptance. 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. Additional details on the Phase 3 trials are available in NEJM and The Lancet publications. The company has submitted New Drug Applications with the U.S. Food and Drug Administration which are currently under review.
BHV-3000-201 is a multicenter, long-term, open-label safety study of rimegepant 75 mg oral tablet, comprising over 1,700 enrolled subjects. Eligible subjects included adults with ≥1 year history of migraine. Subjects could treat migraine attacks of any pain intensity with rimegepant 75 mg up to once daily over the treatment period. Disability was assessed at baseline and Weeks 12, 24, 36, and 52 using the Migraine Disability Assessment (MIDAS) questionnaire. The Migraine-Specific Quality of Life Scale (MSQoL) was also administered at the same time points to measure how migraine affects and/or limits daily functioning.
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, Rutgers, and ALS Biopharma LLC. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation, and myeloperoxidase inhibitor platforms. Biohaven's common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. 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 effectiveness and safety of rimegepant, 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 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 and the Company's Quarterly Report on Form 10-Q for the quarter filed with the Securities and Exchange Commission on August 9, 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, Biohaven's Chief Executive Officer at Vlad.Coric@biohavenpharma.com
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