Taking weight off with a glucagon-like peptide-1 (GLP-1) receptor agonist and keeping it off once the drug has been discontinued has been a tall order but Response Pharmaceuticals Inc. is seeing progress. Top-line results from its randomized, double-blind, placebo-controlled, parallel-group phase II study of RDX-002, in those who had already wrapped up a GLP-1 receptor agonist course for reducing obesity, were positive.
Quince Therapeutics Inc.’s mid-July completion of enrollment in the pivotal phase III study in ataxia-telangiectasia (A-T) marked an important milestone for the South San Francisco-based firm, which is not the only contender in the space. The study called NEAT – a rough acronym for “Neurological Effects of eDSP on Subjects with A-T” – will evaluate Quince’s lead asset, eDSP, in the neurodegenerative illness.
Insmed Inc. CEO William Lewis said that offering two doses of Brinsupri (brensocatib) will complicate payer coverage “not at all, just the opposite. It’s going to give the flexibility to physicians to choose how they want to engage with their patients, wrestle with whatever issues may be in their minds related to safety [and] what have you.” The U.S. FDA approved Insmed’s first-in-class dipeptidyl peptidase 1 inhibitor, Brinsupri, given in 10-mg and 25-mg tablets as a once-daily treatment for noncystic fibrosis bronchiectasis in adults and children 12 and older.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arvinas, Bluebird, Boehringer, GSK, Kalvista, Nrx, Pfizer, Pharmather.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Eli Lilly, Humacyte, Sitryx, Turnstone, Xoma.
Korea Disease Control and Prevention Agency (KDCA) secured 5.3 million doses of COVID-19 vaccines made by Pfizer Inc./Biontech SE and Moderna Inc., officially including the mRNA-based vaccines in the country’s national immunization program on Aug. 5.