TOKYO, July 22, 2020 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced it has been awarded a grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH) in the U.S. to help fund two phase 1 clinical studies to evaluate the safety and efficacy of ASP8062, an oral small molecule GABAB receptor Positive Allosteric Modulator (PAM), as an add-on maintenance therapy for Opioid Use Disorder (OUD). 

With the loss of over 46,802 American lives in 2018 due to overdose of an opioid1, the U.S. federal government declared the opioid crisis a national Public Health Emergency under federal law in October 20172. The grant is part of the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. The NIH HEAL InitiativeSM will accelerate the development of novel medications and devices to treat all aspects of the opioid addiction cycle, including progression to chronic use, withdrawal symptoms, craving, relapse, and overdose.

Astellas has continued research and development to explore new therapeutic possibilities for the opioid crisis and submitted the grant application based on supportive preclinical studies utilizing ASP8062 in various models of substances of abuse, such as the self-administration reduction effect of opioids by ASP8062. These data are highly consistent with other scientific literature which led NIDA to identify ASP8062’s mechanism of action, GABAB PAM, as one of the ‘ten most wanted’ pharmacological mechanisms for treatment of Opioid Use Disorder3. PAM compounds are considered promising therapeutic advances with the potential to improve clinical outcomes for the future by reducing self-administration and drug-seeking behavior, based on their potential ability to positively modulate the effects of endogenous agonists but without many of the side effects commonly associated with direct acting agonists4, 5

Formal approval and funding from NIDA for the phase 1 clinical study program was granted following the opening of an Investigational New Drug (IND) application by the FDA for ASP8062 in OUD in April 2020. Should the phase 1 studies demonstrate appropriate safety measures, a second phase of the grant may be awarded to help fund a randomized double-blind phase 2 study to assess the safety and efficacy of ASP8062 on the reduction of opioid use in OUD patients on stable buprenorphine-based (BUP) therapy. 

“This is an early, but important, step in identifying a potential new approach to tackle the ever-growing opioid crisis,” said Salim Mujais, M.D., Senior Vice President and Therapeutic Area Head, Medical Specialties, Astellas. “Astellas recognizes the serious burden of OUD on patients, their families, and caregivers along with its tragic impact across the world. We are pleased that NIDA has awarded this grant to Astellas to support research of ASP8062,” he continued. “We hope to be able to contribute to the NIH strategy to identify scientific solutions and novel pharmacotherapies to deliver new treatment options for patients battling opioid addiction.”

The grant builds upon Astellas’ long-standing commitment to improving access to health, particularly for the most pressing health concerns, by leveraging its strength and technologies and seeking out unique partnerships to collaboratively address areas of greatest need.

 

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