Kaken Pharmaceutical will hand Alumis $40 million in the near term for the rights to develop a late-stage tyrosine kinase 2 (TYK2) inhibitor as a dermatology treatment in Japan.
The drug in question, dubbed ESK-001, is Alumis’ lead candidate and is designed to correct immune dysregulation in diseases driven by proinflammatory mediators, including well-known targets like IL-23, IL-17, and type 1 interferon. Alumis has already been evaluating the twice-daily modified-release oral formulation in a pair of phase 3 trials in adults with moderate to severe plaque psoriasis.
Alongside that late-stage program, Alumis is also running a phase 2b trial of ESK-001 in patients with systemic lupus erythematosus, which is expected to read out next year. The biotech said it “continues to leverage its precision data analytics platform to explore ESK-001’s potential application in other immune-mediated conditions” and is also working on a once-daily formulation.
Tuesday morning's deal sees Tokyo-based Kaken commit $40 million in upfront and near-term codevelopment payments over this year and next, with the potential to pay up to $140 million in further milestone payments and field option payments as well as tiered royalties.
In return, Kaken has the rights to ESK-001 as a dermatology drug in Japan and will be responsible for clinical and regulatory development along with commercialization in the country. There is also the option for Kaken to expand the licensing deal to cover rheumatological and gastrointestinal diseases.
“We strongly believe in the potential of ESK-001 to address a range of medical needs in the dermatology space and potentially rheumatological and gastrointestinal diseases in the future,” Hiroyuki Horiuchi, president and representative director of Kaken, said in the March 25 release.
Kaken markets a number of products in Japan, including hyaluronate sodium for osteoarthritis and Fiblast for skin ulcers. The company has also licensed a number of drugs from other companies, including seladelpar for primary biliary cholangitis from CymaBay Therapeutics and tildacerfont from Spruce Biosciences for congenital adrenal hyperplasia.
“ESK-001 will be an important addition to the Kaken portfolio of novel therapeutics for dermatology conditions,” Horiuchi added in the release.
Immune-mediated disease specialist Alumis is currently in the process of buying Acelyrin. Alumis’ pipeline is headed up by ESK-001, with the company sharing phase 2 data a year ago that showed the drug met its primary endpoint of the proportion of patients achieving a 75% improvement in the psoriasis area and severity score at Week 12 compared to placebo.
“This partnership builds on the positive phase 2 clinical data of ESK-001, our next-generation oral TYK2 inhibitor, supporting our objectives to unlock its full therapeutic potential and ensure ESK-001 is widely accessible to people with immune-mediated disorders around the world,” Alumis CEO Martin Babler said in this morning’s release.