The latest in a spate of draft and final guidances released recently by the U.S. FDA could help sponsors developing drugs to treat early stage solid tumor malignancies.
Protagonist Therapeutics Inc. continues having a tough time. The latest is a steep stock drop after a phase II trial in ulcerative colitis (UC) missed its primary endpoint, but the company insists the data are good enough to move into phase III. Top-line data showed a 450-mg BID dose of PN-943 in treating moderate to severe UC missed its primary endpoint, which was the number of participants achieving clinical remission at week 12 compared to placebo.
Takeda Pharmaceutical Co. Ltd. has stress-tested Engitix Ltd.’s extracellular matrix (ECM) drug discovery platform and is coming back for more, expanding the existing collaboration from liver fibrosis to inflammatory bowel disease (IBD).
Citing potential confounding factors, Vanda Pharmaceuticals Inc. is hoping further analysis might explain the top-line miss for its phase III study testing tradipitant in gastroparesis, hinting that regulatory submissions could still be in the offing. Investors, unsurprisingly, were less optimistic, sending shares of the Washington-based company (NASDAQ:VNDA) down nearly 18% to close Feb. 4 at $12.03.
LONDON – Engitix Therapeutics Ltd. has raised $54 million in a series A round to advance early programs arising from its human extracellular matrix (ECM) target discovery platform towards the clinic with the support of new partner and equity investor Dompé Farmaceutici SpA.
Merck & Co. Inc., building on a year-old deal with Aligos Therapeutics Inc., has moved to in-license an early stage nonalcoholic steatohepatitis (NASH) oligonucleotide program Aligos had previously advanced independently. The amended deal also gives Merck the right to add a new NASH target to the partnership, in addition to those already part of the agreement. With Aligos eligible to receive up to $460 million in development and commercialization milestones as well as tiered royalties on net sales per target, its rewards could reach $1.38 billion.
Discouraging news from two trials with lirentelimab slammed shares of Allakos Inc. (NASDAQ:ALLK), which ended the day at $8.55, down $75.84, or almost 90%. The Redwood City, Calif.-based firm reported data from Enigma 2, a phase III study in patients with biopsy-confirmed eosinophilic gastritis and/or eosinophilic duodenitis, and Kryptos, a phase II/III experiment in biopsy-confirmed eosinophilic esophagitis. Both experiments met their histologic co-primary endpoints but fell short of statistical significance on patient-reported symptomatic co-primary goals.
CEO Michael Raab said that would-be partners for Ardelyx Inc.’s Ibsrela (tenapanor), cleared in September 2019 to treat irritable bowel syndrome with constipation, “don't understand and don't approach the market in the manner that we will,” which is why the company has chosen to launch the sodium/hydrogen exchanger 3 inhibitor on its own in 2022.
Glaxosmithkline plc (GSK) tapped Arrowhead Pharmaceuticals Inc. for its foray into nonalcoholic steatohepatitis (NASH), as the pair signed an exclusive global licensing deal (excluding China) for GSK to develop and commercialize phase I/II-stage ARO-HSD, Arrowhead’s RNAi therapy targeting HSD17B13.
New and updated preclinical and clinical data presented by biopharma firms at The Liver Meeting of the American Association for the Study of Liver Diseases, including: 89bio, Akero, Cymabay, Intercept, Protagonist, Sagimet, Surrozen, Versantis.
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