Biovie Inc.’s double-barrelled blast of positive data with insulin sensitizer NE-3107 in Alzheimer’s disease (AD) and Parkinson’s disease (PD) launched shares (NASDAQ:BIVI) on a wild ride to close March 1 at $2.23, up 99 cents, or almost 80%, after trading as high as $3.31.
Positive phase III data from Ironwood Pharmaceuticals Inc. with once-weekly glucagon-like peptide-2 analogue apraglutide failed to impress Wall Street, and shares of the Boston-based firm (NASDAQ:IRWD) closed Feb. 29 at $9.43, down $5.69, or 37.6%. The experiment called Stars tested apraglutide to reduce parenteral support in adults with short bowel syndrome with intestinal failure. Rare and severe, the condition affects about 18,000 adults in the U.S., Europe and Japan. Based on the latest data, Ironwood plans to submit an NDA to the U.S. FDA and other regulatory filings.
Pharmaust Ltd.’s monepantel met its primary safety endpoints and showed positive signals of potential efficacy in a phase I trial in patients with motor neuron disease (MND)/amyotrophic lateral sclerosis (ALS). With these results, the company will now progress to a pivotal phase II/III trial by midyear, Pharmaust CEO Michael Thurn told BioWorld.
After trading as low as $2.04, shares of Palatin Technologies Inc. (NYSE:PTN) closed Feb. 28 down $1.57, or 39.7%, ending at $2.39 on word of results from the phase III pivotal Melody-1 trial with melanocortin pan-agonist PL-9643 vs. vehicle in dry eye disease.
Strong early data of Janux Therapeutics Inc.’s tumor-activated T-cell engager compounds JANX-007 and JANX-008 sent the San Diego-based company’s shares surging by 229%, indicating enthusiasm for their best-in-class potential and the possibility of tapping into multibillion-dollar prostate cancer and solid tumor markets.
The enticing prospect – and proven worth – of dually agonizing the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors gained more evidence in a big way from Viking Therapeutics Inc. with VK-2735 in a phase II weight loss study. Shares of San Diego-based Viking Therapeutics Inc. (NASDAQ:VKTX) closed Feb. 27 at $85.05, up $46.57, or 121%, as investors learned that the drug achieved the primary and all secondary endpoints in the phase II study called Venture, with significant body-weight drops at all doses compared to placebo.
Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
Kazia Therapeutics Ltd. stopped its two-part paxalisib plus radiotherapy phase I trial early based on positive safety and promising clinical responses in patients with phosphoinositide 3-kinase pathway mutation brain metastases from solid tumors. The company plans to meet with the U.S. FDA to discuss a pivotal registrational trial.
With a regulatory filing expected later this year for gepotidacin based on positive data in uncomplicated urinary tract infections, GSK plc reported that the potentially first-in-class oral antibiotic hit its endpoints in a phase III trial in uncomplicated urogenital gonorrhea, the sexually transmitted disease facing a rise in incidence rate and increased antibiotic resistance.
In the first month of 2024, BioWorld reported on 252 phase I-III clinical trial updates, marking a 10% decrease from the 281 updates in December 2023, as well as a decline from 354 updates in November and 416 in October. The number of trial updates is also a 10% drop compared to January 2023, which recorded 281 updates.
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