DUBLIN – Abivax SA has started planning for a pivotal phase III program for its inflammatory bowel disease drug candidate, ABX-464, following a readout of top-line data from a phase IIb induction study in ulcerative colitis, in which the molecule attained the primary endpoint at all three dose levels tested. It demonstrated efficacy on a range of secondary endpoints, too, while its safety profile also appeared to be favorable.
Missing the primary endpoint in a phase IIb study of aldafermin for treating nonalcoholic steatohepatitis (NASH) has caused NGM Biopharmaceuticals Inc. to halt the program’s development while rattling the company’s share value. But the failure didn’t stop there as other NASH therapy developers felt the reverberations. South Francisco-based NGM’s stock (NASDAQ:NGM) took a battering May 24 as shares closed down 40.77% at $16.81 each. Others in the NASH space rocked by NGM’s negative data on the day included San Francisco-based 89bio Inc., which is prepping BIO89-100, a glycopegylated FGF21 analogue for a phase IIb NASH study. 89bio’s stock (NASDAQ:ETNB) plunged 14.24% to close at $19.40 per share.
Shares of Annovis Bio Inc. (NYSE:ANVS) leapt 127.3% to $60 May 21 on news that, following 25 days of treatment with its lead candidate, ANVS-401 (posiphen), 14 early Alzheimer's disease patients enrolled in its ongoing phase IIa study showed cognitive improvement of 22% vs. those who received placebo. Pending successful completion of the study, the company is targeting advancement to late-stage studies later this year.
VANCOUVER, British Columbia – Yiviva Inc., a pharmaceutical company focused on developing botanical drugs, has moved its lead candidate further into an international phase IIb trial for liver cancer and closer to an application through the FDA’s little-used botanicals pathway and a similar pathway in China. The company’s lead candidate, YIV-906, is intended for use in immunotherapy, chemotherapy and radiation therapy.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annovis, Aurinia, Beigene, Immunitybio, J&J, Meiji Seika, Medivir, Onconova, Phosplatin, Poxel, Regulus.
CEO David Epstein said Black Diamond Therapeutics Inc. was “delighted” with phase I data testing BDTX-189 in advanced solid tumors harboring EGFR or HER2 alterations, but Wall Street seemed less so. Shares (NASDAQ:BDTX) closed at $13.93, down $8.30, or 37%.
Where Ilaris (canakinumab) failed, can Kineret (anakinra) succeed? Swedish Orphan Biovitrum AB is reporting that an investigator-initiated phase III study of its interleukin-1 (IL-1) blocker, Kineret, in 594 hospitalized COVID-19 patients with moderate or severe pneumonia, who had a poor prognosis, uncovered what appear to be dramatic benefits.
LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of either Astrazeneca plc or Pfizer Inc./Biontech SE’s COVID-19 vaccines.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelrx, Annovis, Astellas, Black Diamond, Cantargia, Crescendo, Laurent, Merck, Obseva, Pyramid, Recardio, Seagen, Sensei, Transcenta, Xalud.
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