Phosphodiesterase-4 (PDE4) is an intracellular pro-inflammatory enzyme that is considered a therapeutic target in inflammatory disorders such as psoriasis, asthma or ulcerative colitis (UC), among others. Researchers from Palisade Bio Inc. have reported preclinical data on PALI-2108, a PDE4 inhibitor prodrug, in models of UC.
A laboratory technique used to generate pluripotent stem cells from any tissue, cellular reprogramming, has led a group of researchers to the discovery of a process that could have an impact on natural tissue repair.
Index Pharmaceuticals Holding AB CEO Jenny Sundqvist said liquidation of the company in the wake of phase III data with cobitolimod in moderate to severe ulcerative colitis (UC) is “one of the options that will be on the table.” Shares of the Stockholm-based firm (STO:INDEX) closed Nov. 22 at SEK0.24 (US2 cents), down SEK0.41, or 63%, on word that an independent data monitoring committee (DMC) has completed the planned dose-selection analysis, including safety review and assessment for futility, of induction Study 1 of the phase III program called Conclude, testing the Toll-like receptor 9 agonist cobitolimod. The DMC concluded that Index’s lead compound is unlikely to meet the primary endpoint, and the company said development will be stopped.
After a delay caused by the April complete response letter from the U.S. FDA for Eli Lilly and Co.’s Omvoh (mirikizumab-mrkz), regulators cleared the drug for moderately to severely active ulcerative colitis (UC) in adults. Given by infusion (300 mg/15 mL)/injection (100 mg/mL), Omvoh stands as the first and only interleukin (IL)-23p19 antagonist for the treatment of moderately to severely active UC in adults – as well as the pharma giant’s first drug approval in the space.
Biologics innovators typically take a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when biosimilar competition is on the horizon.
For a whopping $7.1 billion up front, Roche AG is buying Telavant Holdings Inc., a firm that is owned by Roivant Sciences Ltd. and Pfizer Inc. The deal also includes $150 million on the back end, and Roche gains rights to develop, manufacture and commercialize a fully human monoclonal antibody targeting tumor necrosis factor-like ligand 1A, RVT-3101, for treating inflammatory bowel disease (IBD) and possibly other diseases in the U.S. and Japan. Pfizer retains the rights for the rest of the world.
Abivax SA’s debut on the U.S. market received a somewhat chilly reception Oct. 20, as the firm priced on the low end of its proposed range and ended the first day of trading in the red. But the company managed to pull in about $235.8 million in gross proceeds, the majority of which will support late-stage efforts for obefazimod, an oral candidate with a novel mechanism of action it hopes to advance in the lucrative inflammatory bowel disease space.
Pfizer Inc. may have a blockbuster on its hands with the U.S. FDA’s approval of Velsipity (etrasimod), a selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC).
While Ventyx Biosciences Inc.’s oral S1P1 receptor modulator, VTX-002, achieved primary and secondary endpoints in a phase II ulcerative colitis (UC) trial, the company’s shares (NASDAQ:VTYX) fell 25.9%, or $7.78, closing Oct. 10 at $22.22, possibly due to a higher-than-expected placebo response and a clinical remission rate that was similar to Pfizer Inc.’s etrasimod.
