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Avenue Therapeutics Enters into a Transformational License Agreement with AnnJi Pharmaceutical to Develop and Commercialize AJ201

Friday, March 03, 2023

Specialty pharmaceutical company Avenue Therapeutics, Inc. has announced an exclusive license agreement with AnnJi Pharmaceutical Co., Ltd., a clinical-stage drug company based in Taiwan. The agreement grants Avenue the rights to AJ201, a first-in-class clinical asset currently undergoing a Phase 1b/2a study in the US for the treatment of spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's Disease.

Dr. Alexandra MacLean, CEO of Avenue, expressed enthusiasm about the license for AJ201, stating that it brings a cutting-edge asset into the company's pipeline. AJ201 is a lead molecule in clinical development for treating Kennedy's Disease, a rare neuromuscular disorder. With AJ201 leading the way, Avenue is confident in the potential of its diversified portfolio to deliver value to both investors and patients.

SBMA is a rare genetic neuromuscular disease primarily affecting men. It is caused by a polyglutamine expansion in the androgen receptor (AR), resulting in the production of an abnormal AR protein that forms aggregates responsible for muscle atrophy in the spinal-bulbar region. This condition weakens the bulbar muscles involved in chewing, speech, and swallowing, leading to choking or inhaling food and liquids, which can cause airway infections. SBMA also affects limb muscles, causing difficulty walking and increasing the risk of falls. Currently, there is no effective treatment for SBMA.

AJ201 was specifically designed to modify SBMA through multiple mechanisms, including the degradation of the abnormal AR protein and the stimulation of Nrf1 and Nrf2, which protect cells from oxidative stress that can lead to cell death. In a Phase 1 clinical trial conducted in 2021, AJ201 demonstrated its safety profile. It is currently being evaluated in a Phase 1b/2a multicenter, randomized, double-blind clinical trial across six sites in the US, with patient screening underway. This study aims to assess the safety and clinical response of AJ201 in SBMA patients. The US Food and Drug Administration has granted Orphan Drug Designation (ODD) to AJ201 for the treatment of SBMA, Huntington's Disease, and Spinocerebellar Ataxia.

As part of the license agreement, AnnJi will receive upfront payments of $3 million and is eligible for future milestone payments related to development, regulatory approval, and commercialization, along with royalties based on net sales of the licensed product. Avenue will also issue 831,618 shares of its common stock to AnnJi upon the initial closing of the license transaction and may issue up to an additional 276,652 shares upon achieving a clinical milestone. The license covers the US, Canada, European Union, Great Britain, and Israel as exclusively licensed territories.

Dr. Lindsay A. Rosenwald, Chairman of the Board of Avenue, expressed excitement about advancing the clinical development of AJ201 for the treatment of SBMA and further establishing Avenue as a leading neurological company.

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