Gilead has sold a phase 2-ready addiction candidate to Amygdala Neurosciences. The deal returns control of the ALDH2 inhibitor to the team that was developing the asset before Gilead acquired it in its $1.4 billion takeover of CV Therapeutics.
The 2009 takeover of CVT added angina drug Ranexa to Gilead’s portfolio and padded its pipeline with some prospects, including behavior and substance addiction candidate GS-6637. Gilead put the candidate through a phase 1 program—data from which were shown at conferences in recent years—but has now decided to the sell the drug to Amygdala. Neither company has revealed the terms of the deal.
Responsibility for building on the preclinical efficacy data and safety and pharmacokinetics results from 95 people will now fall on Amygdala, a biotech founded by four former CVT executives.
Ex-CVT CEO Lou Lange, M.D., Ph.D., has taken on the role of executive chairman at Amygdala, leaving the CEO post free for his former SVP of operations, Peter Strumph. The ex-CVT pair are joined at Amygdala by two other former colleagues. Ian Diamond, M.D., Ph.D., and Adrienne MacMillan will work as CSO and CFO, respectively, having previously held posts in the neurology research and finance units at CVT. Lange and Diamond both served as senior advisers to Gilead following its acquisition of CVT.
Having founded the company and acquired GS-6637, their sole asset, the colleagues are working to get the drug into phase 2.
“Completion of this transaction launches Amygdala Neurosciences with a phase-2 ready asset that we believe has the potential to become a treatment for addiction," Strumph said in a statement. “In 2017, we look forward to initiating clinical trials for the treatment of both cocaine and alcohol use disorders.”
Belief that GS-6637, now renamed ANS-6637, can treat cocaine and alcohol disorders is based on the asset’s mechanism of action and preclinical evidence of efficacy. ALDH2 inhibition suppresses production of dopamine, a neurotransmitter that floods into the craving and reward section of the brain when addictive drugs are taken.
CVT found that GS-6637, then known as CVT-10216, reduced alcohol-increased dopamine levels in that part of the brain in preclinical models without affecting normal basal levels. Researchers have also accrued preclinical data on the effect of the candidate against cravings for cocaine and opiates.
The goal now is to get the program moving forward swiftly again. CVT nominated CVT-10216 for development 10 years ago and was gearing up to move the asset into the clinic when Gilead came calling in 2009. Since then, the candidate has come through three small phase 1 studies but has yet to face a clinical test of efficacy.