The biopharmaceutical industry is making a big push toward oral autoimmune disease drugs that offer similar efficacy but more dosing convenience compared to injectable biologic medicines. Boehringer Ingelheim is adding pill prospects to its pipeline, striking a deal for small molecules from startup Sitryx with potential applications in a range of autoimmune and inflammatory disorders.
According to terms of the agreement announced Thursday, Ingelheim, Germany-based Boehringer will receive an exclusive global license to multiple preclinical drug candidates from Sitryx. The total payout to Sitryx could top $500 million, depending on the progress of the research.
Oxford, United Kingdom-based Sitryx develops oral small molecules intended to restore immune balance. The company’s lead wholly owned program is SYX-5219, an inhibitor of PKM2, an enzyme that plays a role in tissue repair and regeneration. This Sitryx drug is in Phase 1 testing for atopic dermatitis and has potential applications in other immunology disorders. The startup’s pipeline also includes programs for indications such as asthma and inflammatory bowel disease.
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Targets for the small molecules heading to Boehringer remain undisclosed. They are all preclinical, which is consistent with the privately held company’s business development strategy. Boehringer prefers to look for drugs in early or preclinical development, Brian Hilberdink, president, U.S. human pharma, said in an interview during the J.P. Morgan Healthcare Conference last month. The company then uses its experience and expertise to complete an asset’s development.
Going in early means Boehringer can deploy its capital across multiple assets rather than making a big and expensive bet on a drug or a company in late-stage development, Hilberdink said. As an example, he referenced the Pfizer and Novo Nordisk bidding war to buy obesity drug developer Metsera late last year. Pfizer won, but only after offers and counteroffers pushed the price tag to $10 billion.
“Playing further upstream, being able to take a long-range view, having a portfolio that crosses multiple therapy areas, means that we’re not living waiting for a patent cliff and we don’t have big revenue voids that we need to be able to cover,” Hilberdink said. “I think that Boehringer is really hedged well across these multiple areas and will continue to just keep plugging money into research and development.”
Boehringer already has oral small molecules for inflammatory disorders. Last October, the FDA approved Jascayd as a treatment for the lung disorder idiopathic pulmonary fibrosis. Additional clinical testing is evaluating this PDE4B inhibitor in systemic sclerosis, a chronic autoimmune disorder affecting internal organs and the skin. Boehringer is testing another small molecule in systemic sclerosis. This sGC activator, avenciguat, is currently in Phase 2 testing.
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Boehringer’s immunology pipeline also includes drugs administered via a needle in the arm. A TREM-1 antagonist codenamed BI 3032950 is currently in Phase 2 development for ulcerative colitis. Last month, the company reached a deal for rights, outside of Greater China, to a preclinical bispecific antibody from Simcere in development for inflammatory bowel disease.
Boehringer and Sitryx did not provide a financial breakdown of their agreement, other than to say the more than $500 million spans upfront and near-term payments along with potential milestone payments. Boehringer now assumes full responsibility for developing the small molecules. If they reach the market, Sitryx is eligible to receive royalties from Boehringer’s sales of commercialized products.
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