Levicept Ltd. is scoping the options for phase III development after reporting positive results from its phase II trial of LEVI-04 in the treatment of pain caused by osteoarthritis of the knee. The full data are yet to be published, but the company said the potentially first-in-class neurotrophin-3 inhibitor demonstrated significant differences from placebo, with a mean reduction in pain score from baseline of more than 50%, for the three doses tested.
Another failure with allosteric tyrosine kinase 2 (TYK2) inhibitor VTX-958 put an end to internal work with the compound, and shares of Ventyx Biosciences Inc. (NASDAQ:VTYX) fell July 29 to $2.24, down 71 cents or 24%, after the firm disclosed results from the phase II, 109-subject trial in moderately to severely active Crohn’s disease (CD).
Ensho Therapeutics Inc. launched in July after licensing a pipeline of four oral α4β7 inhibitors for inflammatory and gastrointestinal disorders, including inflammatory bowel disease (IBD), from EA Pharma Co. Ltd. “Millions of people worldwide are living with IBD,” Ensho founder, president and executive chair Neena Bitritto-Garg recently told BioWorld, “and while there are a number of approved medications to address the symptoms of IBD, it remains a difficult-to-treat disease with high relapse rates for a considerable proportion of patients.”
About four months after varoglutamstat failed in Alzheimer’s disease, Vivoryon Therapeutics NV disclosed data from the Viviad phase IIb study with the same compound in kidney disease that provided cause for hope – and Anne Doering, chief financial officer, said the new data “reinforce our strategic shift.”
Nonalcoholic steatohepatitis was renamed, for the first time in 34 years, to metabolic dysfunction associated steatohepatitis (MASH), but a name change is far from being the biggest development in the field, according to experts at Bioplus Interphex (BIX) Korea 2024.
The U.S. FDA approved three biosimilar products from Samsung Bioepis Co. Ltd., Tanvex Biopharma Inc. and Formycon AG as follow-on biologics to Stelara (ustekinumab), Neupogen (filgrastim) and Eylea (aflibercept), respectively, on June 28.
France’s Théa Open Innovation, a subsidiary of Laboratoires Théa SAS, terminated its licensing agreement with South Korea’s Olix Pharmaceuticals Inc., and returned global rights of Olix’s ocular small interfering RNA (siRNA) biologic agents, OLX-301D and OLX-301A.
New research has pinpointed gene signatures that determine what immune responses will be activated in the development of sepsis, pointing to novel targets and opening the way for the stratification of clinical trials and for patients to be treated on the basis of their immune response, rather than their symptoms.
Aprilbio Co. Ltd. saw its stock surge 30% June 20 after announcing a potential $475 million (₩655.88 billion) deal with Evommune Inc. for autoimmune disease drug candidate APB-R3.
Optimism on Wall Street proved wise and shares of Mirum Pharmaceuticals Inc. (NASDAQ:MIRM) rose accordingly to close June 17 at $33, up $7.08, or 27.3%, as the firm disclosed interim results from two phase IIb studies evaluating volixibat, an oral ileal bile acid transporter (IBAT) inhibitor, in patients with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). The drug proved its mettle in both liver biliary tract-stenosing indications, with no new safety signals turning up, Foster City, Calif.-based Mirum said.
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