Teva Announces Positive Results for TEV-48125 in Phase IIb Chronic Migraine Study Meeting Primary and Secondary Endpoints
Both high and low dose TEV-48125 demonstrated significant reduction in number of headache hours and headache days in patients.
Data establishes proof of concept as the first anti-CGRP study in chronic migraine patients to report.
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) (“Teva”) announced today positive results from a Phase IIb study evaluating the efficacy, safety and tolerability of two doses of subcutaneous TEV-48125, an investigational anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for the prevention of chronic migraine (migraine with headaches on at least 15 days per month).
The study compared two active arms of different doses of TEV-48125, administered as a subcutaneous injection, once a month for three months, against placebo. Results demonstrated that both tested doses of TEV-48125 achieved the primary and secondary efficacy endpoints of the study at one and three months. The data revealed a significant and clinically relevant reduction in both the number of monthly cumulative headache hours, and the number of headache days of at least moderate severity, relative to baseline.
In this study no important safety or tolerability concerns were identified. The adverse event profile for TEV-48125 appeared similar to placebo and supportive of previous Phase I safety data. Of the adverse events reported, mild, transient injection site discomfort and redness was infrequent but higher than that observed in the placebo group. No serious treatment-related adverse events were seen.
“For the first time in chronic migraine, there is clinical data on the positive role of calcitonin gene-related peptide signaling disruption using a monoclonal antibody” said Marcelo E. Bigal, Teva’s Head of Global Clinical Development for Migraine and Headaches.
“Chronic migraine is a challenging, complex and highly debilitating condition that desperately needs effective new treatment options” said Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer. “These results in support of TEV-48125 take us a step closer to realizing the potential of the anti-CGRP ligand-based approach for millions of women and men who suffer from chronic migraine.”
Full results from the study will be presented at a forthcoming meeting and will be submitted to a peer-reviewed journal for publication.
About the Study
The study was a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group, multi-dose study comparing TEV-48125 with placebo. Following a 28 day run-in period, qualifying patients were randomized to one of three treatment arms receiving high dose TEV-48125, low dose TEV-48125 or placebo, given subcutaneously once a month for three months. 261 patients were included in the trial, 172 receiving TEV-48125
Subjects had their headache and health information captured daily during the entire study, using an electronic headache diary system. The study was conducted in approximately 60 centers in the USA.
TEV -48125 (formerly LBR-101/ RN-307) is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a well-validated target in migraine. CGRP signaling may be disrupted by targeting the ligand itself or its receptor.
Teva's approach targets the ligand, allowing for some CGRP signaling during therapy. This avoids the potential effects of a long-term total disruption to the normal physiological functions of the CGRP system – which are unknown.
TEV-48125 is being developed for two distinct migraine indications; chronic migraine and high frequency episodic migraine. Data from a Phase IIb study, evaluating TEV-48125 in the preventive treatment of high frequency episodic migraine, is expected to report in the second quarter of 2015.
TEV-48125 successfully completed five Phase I trials with 94 healthy volunteers. Results were published in Cephalalgia, the official journal of the International Headache Society, in December 2013, and presented at the 2014 annual meeting of the American Academy of Neurology. Most treatment-related adverse events were mild, transient and resolved spontaneously.
About Chronic Migraine:
Approximately 3.2 million Americans, mostly women, suffer from Chronic Migraine*. Chronic migraine is characterized by headaches on at least 15 days per month. Chronic migraine patients are often referred to as the ‘invisible population’ due to the isolating nature of the condition, where patients are left, in many cases, effectively house-bound.
The World Health Organization (WHO), listed chronic migraine as 4th in a table of disabling conditions. This ranked it in the same disability class as quadriplegia, acute psychosis and dementia, and more disabling than blindness, paraplegia, angina or rheumatoid arthritis.**
Chronic migraine imposes a considerable burden on patients, magnified by the paucity of approved treatment options for this condition. More than one in four of all migraineurs are candidates for preventive therapy, and a substantial proportion of those who might benefit from prevention do not receive it.* Consequently, the prophylactic treatment of chronic migraine continues to present considerable challenges, and there remains a significant medical need for new, safe and effective migraine prophylaxis options.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.
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Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix, (215) 591-8912
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