Avenue Therapeutics has signed an exclusive license agreement with Taiwanese clinical-stage drug company AnnJi Pharmaceutical to develop and commercialise the first-in-class clinical asset, AJ201.
Designed to modify SBMA through several mechanisms, AJ201 is currently in a Phase Ib/IIa study in the US to treat spinal and bulbar muscular atrophy (SBMA), which is also known as Kennedy’s Disease.
In the Phase 1b/2a randomised, multicentre, double-blind trial in six US sites, screening of SBMA patients has commenced.
The clinical trial aims to assess AJ201’s safety and clinical response in these patients.
In 2021, AJ201 completed a Phase I study which demonstrated its safety.
The US Food and Drug Administration granted Orphan Drug Designation (ODD) to AJ201 for SBMA, Huntington’s Disease and Spinocerebellar Ataxia indications.
Avenue Therapeutics CEO Alexandra MacLean said: “The license for AJ201 brings a cutting-edge asset into Avenue’s pipeline that is the lead molecule in the clinic to treat Kennedy’s Disease, a debilitating rare neuromuscular disorder.
“With AJ201 leading the way, we are confident in the potential of our diversified portfolio of three assets to deliver value for investors in the near term and patients in the longer term.”
Under the agreement terms, AnnJi will receive $3m in upfront payments and is eligible for future development, regulatory and commercialisation milestone payments, along with royalties on net licensed product sales.
In connection with the initial closing of the license transaction, Avenue will also issue 831,618 shares of its common stock to AnnJi.
Avenue will also issue up to an additional 276,652 shares on achieving a clinical milestone, aggregating in total to not more than 19.99% of the company’s current total number of outstanding common stock shares.
The agreement includes Canada, the US, European Union, Great Britain and Israel as exclusively licensed territories.