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.
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.
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.
The first – and handsomely upsized – IPO of this year by CG Oncology Inc., along with the sizeable financing Feb. 14 by Engene Holdings Inc., proved Wall Street’s interest in non-muscle invasive bladder cancer, where a number of other players also are busy.
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.
On the verge of top-line data from its phase IIb trial with oral small-molecule CC chemokine receptor 4 (CCR4) antagonist zelnecirnon in atopic dermatitis (AD), due around the middle of this year, Rapt Therapeutics Inc. said the U.S. FDA has imposed a clinical hold on that study with the otherwise promising drug, also known as RPT-193, in AD as well as the phase IIa trial with the same compound in asthma.
Kalvista Pharmaceuticals Inc.’s positive phase III news Feb. 13 with sebetralstat, an oral on-demand kallikrein inhibitor, in hereditary angioedema (HAE), sparked Wall Street speculation about competitor Pharvaris BV with deucrictibant, a bradykinin B2 receptor antagonist.
Alnylam Pharmaceuticals Inc.’s decision to change its analysis plan for the phase III Helios-B trial of RNAi therapeutic Amvuttra (vutrisiran) to treat transthyretin amyloidosis with cardiomyopathy, pushing top-line results back by three months, pressured its share price (NASDAQ:ALNY) down by 10% on Feb. 15, while also boosting shares of competitor Bridgebio Pharma Inc. (NASDAQ:BBIO) by 14%.
Inventiva SA has halted enrollment in its pivotal phase III Nativ3 trial with nonalcoholic steatohepatitis (NASH) candidate lanifibranor after a patient experienced raised liver enzymes indicative of autoimmune hepatitis. The resulting delays to the study could spell trouble for the firm, which estimates its cash runway will only see it through to the start of the third quarter 2024.
RSS
