Due to the “dynamic nature of the situation,” officials of Cymabay Therapeutics Inc. declined to comment on the stoppage of work with PPAR-delta agonist seladelpar, but in a press release they pointed to “a series of investigative actions [that have begun in order] to better understand these findings.”
Fractyl Laboratories Inc. is pioneering a procedure known as duodenal mucosal resurfacing (DMR) to reverse chronic metabolic disorders. This month it has reported positive results from a couple of clinical trials that are shaping its planning for a pivotal trial that is slated to start next year in type 2 diabetes patients.
BOSTON – For diagnosing nonalcoholic steatohepatitis (NASH), liver biopsy is "the reference standard," Dean Hum, president of Genfit Corp., told BioWorld MedTech. "I'm not going to call it the gold standard."
BOSTON – For diagnosing nonalcoholic steatohepatitis (NASH), liver biopsy is "the reference standard," Dean Hum, president of Genfit Corp., told BioWorld. "I'm not going to call it the gold standard." Some of the reasons for denying biopsies a gold sticker are obvious. Biopsies are invasive, which makes them risky, expensive and loathed by patients and doctors alike. "In the real world, doctors don't always do biopsies – many say they very rarely do biopsies unless other data points in several directions and they need that for clarity," Gail Cawkwell told BioWorld.
Gilead Sciences Inc.'s third-quarter earnings, though deemed satisfactory, brought lukewarm responses from Wall Street, with analysts such as J.P. Morgan's Cory Kasimov writing in a report that "these days the company's quarterly progress seems to take a back seat to how they [will] ultimately deploy their substantial amount of capital. The Galapagos deal notwithstanding, this feels like a long wait that's quite frankly getting a bit stale." Still reverberating is the arrangement this summer with Galapagos NV, of Mechelen, Belgium, which signed a 10-year research and development pact with Gilead under which Galapagos is getting $3.95 billion up front in hard cash plus another $1.1 billion in equity, in return for which Gilead will essentially have an option to ex-European rights on everything emanating from the firm's clinical and preclinical pipeline.
BEIJING – Hightide Therapeutics Inc., of Shenzhen, China, and Rockville, Md., said it finished the enrollment in phase IIa trials for its lead asset, HTD-1801, which is a potential first-in-class new molecular entity for primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH).
South San Francisco-based Pliant Therapeutics Inc. CEO Bernard Coulie told BioWorld that Novartis AG was drawn to the $80 million deal in nonalcoholic steatohepatitis (NASH) because other firms working in the integrin space "are very much focused on early stages of the disease, with what we call a metabolic approach. We are addressing with our compound, which is a pure antifibrotic, the late stage of the disease, [categorized as] F3 and F4, where most of the liver is already gone. We think that the real market will be there, because that's where health care costs go up" and where patients facing an increased mortality rate "need proper treatment rather than changing their lifestyle" while using something milder.
Altimmune Inc. will acquire Spitfire Pharma Inc. and its lead candidate, SP-1373 (to be renamed ALT-801), a GLP-1/glucagon receptor co-agonist for treating nonalcoholic steatohepatitis (NASH).
Korea's largest pharmaceutical company, Yuhan Corp., and German giant Boehringer Ingelheim GmbH (BI) have signed a collaboration and license agreement to develop a first-in-class dual agonist to treat nonalcoholic steatohepatitis (NASH) and related liver diseases, following a similar path trod by other companies.
