Biogen has soured quickly on the Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib. Just 19 months after paying $125 million for the ex-China rights in multiple sclerosis (MS), the Big Biotech is punting the prospect back to InnoCare Pharma.
The idea of treating MS by targeting BTK had attracted its fair share of skepticism by the time Biogen joined the race in the summer of 2021, with short sellers pillorying Principia Biopharma’s prospects. But companies have continued to bet big on the approach, with Sanofi paying $3.7 billion to buy Principia and Merck KGaA taking its challenger into phase 3.
Biogen has a long-standing interest in BTK, having licensed a cancer candidate in 2014 and taken its own MS prospect into the clinic in 2019, and identified orelabrutinib as a molecule capable of unlocking the therapeutic value of the mechanism in multiple sclerosis.
Speaking at the time of the deal, Alfred Sandrock Jr., M.D., Ph.D., then the head of R&D at Biogen, said the “high selectivity and CNS penetrance” of orelabrutinib “may translate to potential clinical advantages relative to other BTKi programs.” Less than two years later, neither Sandrock nor orelabrutinib are still at Biogen.
In a statement (PDF) to investors in China, InnoCare said it remains confident in the candidate. The next big test of that confidence is just months away, with InnoCare’s phase 2 clinical trial of orelabrutinib in MS set to reach primary completion in the summer. The Biogen deal could have been worth up to $812.5 million in milestones.
InnoCare continued to work on orelabrutinib after the Biogen deal, which only covered MS, and is taking the candidate forward in multiple autoimmune and oncology indications. On the autoimmune side, the Chinese drug developer sees a future for the BTK inhibitor in the treatment of diseases including lupus, immune thrombocytopenia and neuromyelitis optica spectrum disorder.
Biogen disclosed its decision to drop orelabrutinib alongside news that it is discontinuing vixotrigine, also known as BIIB074, for the potential treatment of diabetic painful neuropathy and is taking a related $119.6 million impairment charge. “Regulatory, development and commercialization challenges” underpinned Biogen’s discontinuation of vixotrigine, according to the company's fourth-quarter earnings presentation. Biogen ran more than 20 studies of the candidate, which it acquired in the 2015 Convergence Pharmaceuticals buyout.