NEW HAVEN, CT, USA I July 24, 2017 I Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that it has commenced enrollment in the first of its two registrational Phase 3 clinical trials to evaluate the safety and efficacy of orally-dosed rimegepant (BHV-3000) for the acute treatment of migraine. Biohaven expects to begin enrollment in the second Phase 3 clinical trial this summer and report topline results for both studies in the first half of 2018.
“Large numbers of migraine patients, including those with cardiovascular disease or hypertension for whom existing treatment options such as triptans are contraindicated, may benefit from a safe and effective oral CGRP receptor antagonist medication that provides rapid and sustained relief from pain,” said Vlad Coric, M.D., Chief Executive Officer at Biohaven. “Based on the results of its Phase 2b clinical trial, we believe rimegepant has the potential to be a best-in-class treatment option, combining early, comprehensive, and durable efficacy with convenient oral dosing, so that patients are spared the need for any intravenous or subcutaneous administration.”
Biohaven plans to conduct two double-blinded, placebo-controlled Phase 3 clinical trials to evaluate the efficacy and safety of 75 mg of rimegepant, Biohaven’s innovative, orally-dosed small molecule CGRP receptor antagonist, for the acute treatment of migraine. The co-primary endpoints of the studies are freedom from pain at two hours post-dosing and a demonstrated effect on the patient’s most bothersome symptom (nausea, photophobia or phonophobia) at two hours post-dosing. Patients in the Phase 3 clinical trials will be eligible to participate in a long-term safety study.
In a previously completed Phase 2b clinical trial, the 75 mg dose of rimegepant was observed to have achieved statistically significant improvement compared to placebo at two hours post-dosing on all four key migraine symptoms: pain, nausea, photophobia and phonophobia. To the company’s knowledge, rimegepant is the only oral, small molecule CGRP receptor antagonist currently in development that has achieved statistically significant improvement on all four of these key migraine symptoms within a single study. Rimegepant treated patients also experienced durable efficacy, achieving statistically higher rates of pain freedom at 24 and 48 hours post-dosing compared to placebo.
Rimegepant is the most advanced candidate in Biohaven’s CGRP receptor antagonist platform. Biohaven is also pursuing the development of BHV-3500 for the treatment of patients with chronic and episodic migraine. Biohaven’s CGRP platform is focused on delivering oral or intranasal therapies for migraine that are easy to use for patients when and where a debilitating migraine attack hits.
“We are very pleased to begin the Phase 3 development of this important product candidate for migraine sufferers. We also plan to demonstrate, through our long-term safety study, a low risk of cardiovascular side effects and favorable safety profile in addition to comprehensive and durable treatment effects observed in the acute studies,” said Elyse Stock, M.D., Chief of Portfolio Development and Strategy at Biohaven.
About Migraine
Migraine is both widespread and disabling neurological disorder. The Migraine Research Foundation ranks migraine as the world’s third most prevalent illness, affecting approximately 36 million people in the United States. Current treatment approaches, such as triptans, can be limited by headache recurrence within 24 hours after taking migraine medication, as well as cardiovascular contraindications and warnings.
About Biohaven
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, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven’s lead development programs include multiple compounds across its CGRP receptor antagonist and glutamate modulation platforms. The company’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.
SOURCE: Biohaven
Post Views: 24
NEW HAVEN, CT, USA I July 24, 2017 I Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that it has commenced enrollment in the first of its two registrational Phase 3 clinical trials to evaluate the safety and efficacy of orally-dosed rimegepant (BHV-3000) for the acute treatment of migraine. Biohaven expects to begin enrollment in the second Phase 3 clinical trial this summer and report topline results for both studies in the first half of 2018.
“Large numbers of migraine patients, including those with cardiovascular disease or hypertension for whom existing treatment options such as triptans are contraindicated, may benefit from a safe and effective oral CGRP receptor antagonist medication that provides rapid and sustained relief from pain,” said Vlad Coric, M.D., Chief Executive Officer at Biohaven. “Based on the results of its Phase 2b clinical trial, we believe rimegepant has the potential to be a best-in-class treatment option, combining early, comprehensive, and durable efficacy with convenient oral dosing, so that patients are spared the need for any intravenous or subcutaneous administration.”
Biohaven plans to conduct two double-blinded, placebo-controlled Phase 3 clinical trials to evaluate the efficacy and safety of 75 mg of rimegepant, Biohaven’s innovative, orally-dosed small molecule CGRP receptor antagonist, for the acute treatment of migraine. The co-primary endpoints of the studies are freedom from pain at two hours post-dosing and a demonstrated effect on the patient’s most bothersome symptom (nausea, photophobia or phonophobia) at two hours post-dosing. Patients in the Phase 3 clinical trials will be eligible to participate in a long-term safety study.
In a previously completed Phase 2b clinical trial, the 75 mg dose of rimegepant was observed to have achieved statistically significant improvement compared to placebo at two hours post-dosing on all four key migraine symptoms: pain, nausea, photophobia and phonophobia. To the company’s knowledge, rimegepant is the only oral, small molecule CGRP receptor antagonist currently in development that has achieved statistically significant improvement on all four of these key migraine symptoms within a single study. Rimegepant treated patients also experienced durable efficacy, achieving statistically higher rates of pain freedom at 24 and 48 hours post-dosing compared to placebo.
Rimegepant is the most advanced candidate in Biohaven’s CGRP receptor antagonist platform. Biohaven is also pursuing the development of BHV-3500 for the treatment of patients with chronic and episodic migraine. Biohaven’s CGRP platform is focused on delivering oral or intranasal therapies for migraine that are easy to use for patients when and where a debilitating migraine attack hits.
“We are very pleased to begin the Phase 3 development of this important product candidate for migraine sufferers. We also plan to demonstrate, through our long-term safety study, a low risk of cardiovascular side effects and favorable safety profile in addition to comprehensive and durable treatment effects observed in the acute studies,” said Elyse Stock, M.D., Chief of Portfolio Development and Strategy at Biohaven.
About Migraine
Migraine is both widespread and disabling neurological disorder. The Migraine Research Foundation ranks migraine as the world’s third most prevalent illness, affecting approximately 36 million people in the United States. Current treatment approaches, such as triptans, can be limited by headache recurrence within 24 hours after taking migraine medication, as well as cardiovascular contraindications and warnings.
About Biohaven
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, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven’s lead development programs include multiple compounds across its CGRP receptor antagonist and glutamate modulation platforms. The company’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.
SOURCE: Biohaven
Post Views: 24
