Theratechnologies Inc. paused enrollment of a phase I trial testing TH-1902, its lead peptide-drug conjugate for sortilin-expressing cancers, after finding efficacy "not convincing enough" nor outweighing adverse events in some participants, an undisclosed number of which experienced neuropathy and eye toxicity, the company said.
A diverse group of government and academic researchers, marking World AIDS Day 2022, have published details of an investigational vaccine they said safely induced broadly neutralizing antibody-precursors against HIV in nearly all participants in a small phase I trial.
Word that big pharma firms are sniffing around Horizon Therapeutics plc as a takeover candidate caused not only that firm’s shares to jump but also provided a boost for Viridian Therapeutics Inc., which has a thyroid eye disease (TED) candidate set to challenge Horizon’s Tepezza (teprotumumab-trbw), cleared by the U.S. FDA in January 2020.
Eisai Co. Ltd. and Biogen Inc. presented the full data set for the Clarity Alzheimer’s disease trial of lecanemab at the 2022 Clinical Trials on Alzheimer’s Disease, which was simultaneously published in the New England Journal of Medicine. The data supported the top-line results released in September 2022.
Wall Street’s reaction to phase I news in chondrosarcoma from Inhibrx Inc. puzzled some onlookers and brought renewed attention to the rare disease, which is also the most common form of primary bone cancer in adults. Big pharma and smaller concerns have been throwing drug prospects at the condition for years without much luck.
The shadow of two reported patients’ deaths hovers over Eisai Co Ltd. and Biogen Inc.’s Alzheimer’s disease treatment, lecanemab, as the companies prepare to present phase III study data on the drug later today at the 15th Clinical Trials on Alzheimer's Disease conference.
Axsome Therapeutics Inc.’s AXS-05 (dextromethorphan + bupropion) has notched another success by hitting its phase III primary endpoint in treating a notoriously difficult Alzheimer’s disease (AD) indication when compared to placebo. Newly released data from the Accord study showed AXS-05, an oral, NMDA receptor antagonist with multimodal activity, statistically significantly delayed time to relapse of AD agitation vs. placebo (p=0.014), which was the primary endpoint.
Shares of Cincor Pharma Inc. (NASDAQ:CINC) took a serious hit on top-line findings from the completed phase II Halo study with once-daily oral baxdrostat, but the clinical program with the aldosterone synthase inhibitor remains on track, and an NDA submission is targeted for 2025. The stock closed at $14.11, down $12.42, or 46.8% after Waltham, Mass.-based Cincor informed Wall Street that results from Halo, which enrolled patients taking as many as two blood pressure medications at the maximally tolerated doses without satisfactory results, missed statistical significance on its primary endpoint evaluating change from baseline in mean seated systolic blood pressure in the intent-to-treat population, which included 249 patients.
Avenue Therapeutics Inc.’s takeover of Baergic Bio Inc. pursuant to the previously disclosed share contribution agreement with its parent company, Fortress Biotech Inc., highlighted the potential of targeting GABAA, an approach under investigation in various quarters.
Nearing the end of 2022, the COVID-19 pandemic clearly no longer dominates the clinical activity reported by biopharma companies. Overall clinical data tracked by BioWorld is down significantly, as is the proportion focused on the SARS-Cov-2 virus. Therapeutics and vaccines targeting cancer, infectious diseases and neurological disorders, however, remain a stronghold.
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