Peking University researchers in collaboration with the NIH have discovered a new biochemical pathway related to a bacterium that eliminates nicotine in the intestine. The findings could lead to new ways to improve nonalcoholic fatty liver disease in smokers.
The May 2014 approval of Takeda Pharmaceutical Co. Ltd.’s Entyvio (vedolizumab) brought welcome news in the form of an important mechanism of action for patients with ulcerative colitis and Crohn’s disease, but also means a burdensome course of administration – 30 minutes’ worth of infusion every six weeks, a drawback that other developers are trying to remedy. Standouts among the up-and-comers are Morphic Holding Inc., with an oral candidate that works through the same mechanism of action as Entyvio, and Protagonist Therapeutics Inc.
Connect Biopharma Holdings Ltd. pointed to positive secondary endpoint data and a numerical trend on the primary endpoint in favor of its S1P receptor modulator, CBP-307, in ulcerative colitis, but those results weren’t enough to keep the stock (NASDAQ:CNTB) from falling by more than 57% to close at 82 cents, as investors focused on the primary endpoint miss and the company’s decision to partner the program going forward.
Xbiome Inc. acquired M-201, a clinical-stage program from Assembly Biosciences Inc., to treat patients with mild to moderate ulcerative colitis as it looks to develop products to address the growing incidence of bowel disease throughout Asia. The company expects to start a phase Ib trial of the oral live biotherapeutic product in the U.S. in 2022 and also plans to run clinical trials in China.
In a deal that could be worth more than $450 million, Olix Pharmaceuticals Inc. and Hansoh Pharmaceutical Group Co. Ltd. have agreed to discover, develop, and commercialize siRNA therapeutics for various liver-based targets implicated in cardiovascular, metabolic, and other indications.
Japan’s Ministry of Health, Labour and Welfare approved Takeda Pharmaceutical Co. Ltd.’s Alofisel (darvadstrocel) to treat complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease. This marks the first allogeneic stem cell therapy to be greenlighted in the country.
Recently published phase II data with Takeda Pharmaceutical Co. Ltd.’s TAK-906 (trazpiroben), a dopamine D2/D3 receptor antagonist, fueled hope for patients as Processa Pharmaceuticals Inc. proceeds with a different – and more focused – approach against gastroparesis.
Building on a March deal leveraging lipid nanoparticle (LNP) technology from Genevant Sciences Corp. to fight liver fibrosis, Takeda Pharmaceutical Co. Ltd. has signed a second agreement with the company for the development and commercialization of therapies for up to two rare liver diseases. The deal includes up to $303 million in up-front and potential milestone payments for Genevant, plus royalties on possible product sales, adding to the first deal's similarly structured $600 million package.