Ulcerative colitis is the lead indication for Odyssey Therapeutics’ internally discovered lead drug candidate. With the IPO proceeds, Odyssey plans mid-stage clinical trials evaluating the small molecule in combination with Takeda’s Entyvio and as a monotherapy.
Coultreon Biopharma’s lead drug candidate, acquired from Galapagos, is a small molecule designed to selectively inhibit a novel immunology target called SIK3. The Series A financing will support Phase 2 clinical trials in psoriasis and ulcerative colitis.
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The Teva Pharmaceuticals and Sanofi drug, duvakitug, showed statistically significant and clinically meaningful results in a Phase 2b study in ulcerative colitis and Crohn’s disease. The drug is part of an emerging class of therapies that target TL1A, a protein involved in signaling that drives inflammation.
Eli Lilly’s Morphic acquisition brings an oral small molecule that blocks the same target as Entvyio, an injectable inflammatory bowel disease drug from Takeda Pharmaceutical. The Morphic deal follows Lilly’s 2023 acquisition of Dice Therapeutics, another company developing oral immunology medications.
AbbVie is acquiring Landos Biopharma, whose lead drug is a small molecule that takes a novel approach to treating ulcerative colitis. Preliminary proof-of-concept data from a Phase 2 study are expected later this year.
Abivax pulled off stock market deals in the U.S. and Europe that infuse the biotech with capital to continue clinical development of a small molecule for inflammation that’s differentiated from biologic therapies. In other biotech IPO news, Cargo Therapeutics and Invea Therapeutics both filed paperwork to go public.
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Roche’s Telavant acquisition comes as the Roivant Sciences subsidiary prepares its main asset for Phase 3 testing in ulcerative colitis. The antibody drug candidate blocks a novel target for inflammation and fibrosis that’s also the focus of clinical-stage programs of other big pharma companies.
Pfizer’s new FDA-approved ulcerative colitis drug Velsipity comes from its $6.7 billion Arena Pharmaceuticals acquisition. The small molecule will compete against blockbuster Bristol Myers Squibb drug Zeposia, which addresses the same target.
Rejection of Eli Lilly’s mirikizumab means that two of the four drugs the pharma giant identified as revenue growth drivers for 2023 have failed to pass the regulatory bar. One of those drugs has been approved while the fourth drug still awaits an FDA decision.
A pharmaceutical giant reported a Phase 3 success for a potential blockbuster drug, while four other companies reported disappointing data from their respective clinical trials. Our recap of data readouts and regulatory news also includes one FDA rejection.
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Sales of blockbuster Pfizer drug Xeljanz are under pressure from a stronger safety warning placed across that drug’s entire class. In acquiring Arena Pharmaceuticals for $6.7 billion, Pfizer gets a lead compound with a different and potentially safer approach to treating inflammatory conditions.
Bristol Myers Squibb drug deucravacitinib missed the main and secondary goals of a Phase 2 study in ulcerative colitis. Despite the clinical trial failure, the drug previously posted positive Phase 3 results in plaque psoriasis and BMS still projects the molecule will become a blockbuster seller in multiple autoimmune conditions.
The Theravance Biopharma drug is the lead program in an alliance with Johnson & Johnson subsidiary Janssen Biotech, which paid $100 million up front to develop the JAK inhibitor for intestinal diseases. Following the Phase 2 failure, Theravance said it will minimize spending on that program.
The timing of the filing appears to allay concerns that the FDA would require completion of a study evaluating the testicular safety of the drug, filgotinib, and thus push its launch date from 2020 to 2021-22, an analyst wrote.
More funding and another powerful pharma backer have entered the microbiome space, showing that at least some investors and pharma execs believe the field can begin converting preclinical ideas into valid human therapies.