NEW HAVEN, Conn., July 15, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announces that The Lancet published online positive results from a Phase 3 pivotal clinical trial of rimegepant Zydis® orally dissolving tablet (ODT) for the acute treatment of migraine. These data show that compared to placebo, patients treated with a single dose of the rimegepant ODT formulation experienced rapid and sustained clinical benefits.
"The results from this pivotal Phase 3 study show the significant clinical benefits of freedom from pain and of the most-bothersome migraine-associated symptom within two hours after a single dose of the rimegepant ODT," said Richard B. Lipton, M.D., Senior Author, Professor and Vice Chair of Neurology at the Albert Einstein College of Medicine and Montefiore Health System, Director of the Montefiore Headache Center. "Migraine has a significant impact on patients' lives, with more than 90 percent being unable to work or function while they are experiencing a migraine. We found that rimegepant ODT could be an effective new option for those who don't respond to current available treatments." Dr. Lipton is also a paid consultant and shareholder of Biohaven.
In this pivotal Phase 3 double-blind, randomized, placebo-controlled trial of rimegepant ODT, 1,375 patients were randomized and treated and 1,351 were evaluated for efficacy (rimegepant n=669, placebo n=682). The trial included endpoints to define the time course of the therapeutic actions of the rimegepant ODT. The use of endpoints earlier than two hours had not been previously investigated. Rimegepant was shown to be superior on 21 prespecified endpoints with statistical significance demonstrated on the co-primary endpoints of pain freedom and freedom from the most bothersome symptom at two hours post-dose, as well as numerous secondary endpoints defining early and sustained benefits.
Key findings from the study include rimegepant ODT's significant superiority to placebo on the co-primary endpoints at two hours post-dose for pain freedom (21.2% vs. 10.9%, p<0.0001) and freedom from the most bothersome symptom (35.1% vs. 26.8%, p=0.0009). Rimegepant ODT was superior to placebo on 19 secondary endpoints (p<0.05), including pain relief at 60 minutes (36.8% vs. 31.2%), ability to function normally at 60 minutes post-dose (22.3% vs. 15.8%), pain freedom at 90 minutes (15.1% vs. 7.3%) and freedom from the most bothersome symptom at 90 minutes (27.4% vs. 21.5%), no rescue medication use within 24 hours (85.8% vs. 70.8%), and sustained pain freedom from two to 48 hours (13.5% vs. 5.4%) and pain relief from two through 48 hours post-dose (42.2% vs. 25.2%).
"We are thrilled with the publication of these Phase 3 trial results of rimegepant ODT in TheLancet, an international and influential scientific journal, just days after our oral tablet Phase 3 study was published in TheNew England Journal of Medicine. These data show rimegepant ODT is a differentiated formulation by demonstrating the time course of effect with early and sustained efficacy and placebo-level tolerability," said Vlad Coric, M.D., Chief Executive Officer of Biohaven. "Research confirms that up to one-third of patients are dissatisfied with their current acute treatment of migraine. These results show that rimegepant ODT has the potential to meet patients' needs by providing faster and sustained relief in a convenient form of administration."
This is the third pivotal Phase 3 clinical trial of rimegepant for the acute treatment of migraine. Results from the first two clinical trials of rimegepant oral tablet have previously been published (study 302 in TheNew England Journal of Medicine) or presented at scientific meetings. The results of all 3 trials show significant consistency in meeting the co-primary endpoints of pain freedom and freedom from most-bothersome symptoms at 2 hours. The trials were also consistent in showing meaningful gains over placebo in both pain relief and freedom from functional disability at two hours post-dose. Results from the rimegepant oral tablet Phase 3 trials also showed increasing benefit in relief from migraine-associated symptoms after dosing, with a greater proportion of rimegepant patients achieving freedom from photophobia (light sensitivity), phonophobia (sound sensitivity) and nausea over eight hours as compared to placebo. Across the three trials, rimegepant was generally well tolerated, with the most frequent adverse event, nausea, occurring in 1.5% of rimegepant patients, as compared to 0.8% of patients on placebo. Additionally, rimegepant demonstrated a liver safety profile similar to placebo.
Rimegepant is Biohaven's orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist, which the Company is developing as a treatment for migraine and refractory trigeminal neuralgia. The efficacy and safety profile of rimegepant for the acute treatment of migraine, as compared to placebo, has now been established across four randomized controlled trials to date: 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 provided the basis for Biohaven's NDA submission to the FDA in the second quarter of 2019. More information about rimegepant can be found at the Company's website: https://www.biohavenpharma.com/science-pipeline/cgrp/rimegepant
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 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," "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 ended March 31, 2019, filed with the Securities and Exchange Commission on May 8, 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 [email protected]