A large biotech company has made a deal with a smaller firm to incorporate a new weapon into its arsenal against nonalcoholic steatohepatitis: machine learning.
Foster City, California-based Gilead Sciences said Tuesday that it had partnered with Insitro, based in nearby South San Francisco, to discover and develop new drugs for NASH. Insitro uses a platform called Human, or ISH, which combines genetics and functional genomics with machine learning to generate in vitro models to drive drug discovery and development. ISH will be used to provide information about disease progression, suggest drug candidate targets and predict responses to potential therapies, while Gilead will have rights to advance up to five targets and responsibility for chemistry and development efforts.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
NASH is a form of fatty liver disease incidental to obesity and Type 2 diabetes. It is on the rise around the world and is expected by many analysts to represent a market that will explode in value over the next few years, but as yet has no approved treatments.
Under the deal between the two companies, Gilead will pay Insitro $15 million upfront, with near-term milestones of up to $35 million and another potential $200 million in preclinical, development, regulatory and commercial milestones. Insitro will also be eligible for low double-digit royalties, co-development and co-detail in the US, profit sharing in China and other milestones and royalties on sales outside the US.
The news comes less than a week after Gilead announced another NASH partnership, with Danish drugmaker Novo Nordisk. Under that deal, the two companies will conduct a proof-of-concept clinical trial combining Novo Nordisk’s diabetes drug Ozempic (semaglutide) with two Gilead drugs, the FXR agonist cilofexor and the ACC inhibitor firsocostat. The companies may also collaborate on preclinical research in NASH. In February, Gilead’s NASH efforts suffered a setback when a Phase III trial of another drug it was developing for the disease, selonsertib, failed to meet its primary endpoint, sending the company’s shares down more than 4 percent.
For now, New York-based Intercept Pharmaceuticals has the lead in the race to develop a drug for NASH, having announced positive interim Phase III data for its drug, Ocaliva (obeticholic acid). Further data from the same study announced at the European Association for the Study of the Liver’s annual conference last week showed continued improvement, though it also raised questions among investors about a lack of intent-to-treat analysis and an imbalance in gall stone and gallbladder inflammation events between the arms of the trial.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Another firm, France’s Genfit, presented data at the EASL conference presented clinical and preclinical data that left B. Riley FBR analyst Mayank Mamtani encouraged about prospects of the Phase III study of its drug, elafibranor, having a successful readout in the fourth quarter of this year.
Photo: eranicle, Getty Images
