Keen to turn a new page, Indivior branches out, picking up an option for cannabis addiction drug
Having put the scandal around its flagship opioid addiction drug behind it, Indivior is branching out the substance abuse portfolio.
The latest addition comes in the area of cannabis-related disorders, as Indivior buys an option to license a CB1 inhibitor from France’s Aelis Farma for the treatment of diseases like cannabis addiction and cannabis-induced psychosis. They’re putting down $30 million in cash and promising a $100 million license fee payment should they decide to exercise the option after seeing Phase IIb data.
Despite its checkered history — until last year, Indivior had been mired in a yearslong battle with the Department of Justice over its marketing practices, leading to the jailing of its former CEO Shaun Thaxter — Aelis CEO Pier Vincenzo Piazza considers his new partner the leader in drug addiction treatment.
And he believes the company, now led by CEO Mark Crossley, has resolved the issues and is ready to turn a new page.
“What I know is that if you look at the history of Indivior, they have been very good at setting up a commercial network for addiction drugs, so they are the first company to build up a large scale,” said Piazza, who happens to be longtime friends with Indivior CSO Christian Heidbreder. “They are a company if you look also at the other assets they have acquired, they are a company that is very smart in choosing new drugs they want to develop, innovation they want to develop.”
The deal is a culmination of seven years of work by Piazza since his group at the Neurocentre Magendie in Bordeaux shed light on an endogenous molecule that the brain uses to counteract the effects of cannabis, named pregnenolone. They set out to copy that natural mechanism, and Aelis was spun out with a whole slate of CB1 inhibitors, each targeting different parts of the receptor.
With the first generation of CB1 blockers, he explained, scientists looked at endogenous agonists that bind to the receptor like a key and a lock. Jamming up that key-lock entrance doesn’t just block the problematic hyperactivity, they also block everything — leading to toxicities in the brain that rendered them unusable. By contrast, Aelis’ compounds bind to different spots on the receptor that tinker with the intracellular activities.
“So what they do, they go from too much to normal,” he said, “while the molecules before us, they went from too much to too little.”
The field has seen a resurgence of interest in CB1 following the early setbacks, with efforts ranging from agonists deployed in psychiatry to a peripherally acting approach for NASH, diabetes and others.
Indivior has laid claims to the lead candidate, AEF0117, and the two companies are in final preparations to start recruiting for a Phase IIb trial around the end of 2021 and the beginning of 2022. Frances Levin of Columbia University has been tapped to run the two-year study, which is designed to have 350 to 400 patients.
If it’s a success, Indivior can take over all development and commercialization, bringing to market what Crossley calls the first medication for cannabis use disorders.