Eyebiotech Ltd. doubled the size of its series A round, raising $130 million to advance a pair of assets, with a phase Ib/IIa trial dubbed Amarone underway testing the drug called Restoret in patients with diabetic macular edema and neovascular, or wet, age-related macular degeneration.
Bayer AG said it will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market after a confirmatory trial required by the FDA failed to meet the primary endpoint of progression-free survival vs. standard immunochemotherapy in patients with relapsed follicular lymphoma. It marks the latest stumble for PI3K-targeting drugs in the non-Hodgkin’s lymphoma space.
Immvira Group Co. plans to progress its intravenous oncolytic herpes simplex virus (oHSV) MVR-T3011-IV to phase II trials after completing a phase I study in the U.S. in patients with late-stage solid tumors. The Shenzhen, China-based company is the first to conduct clinical trials via intravenous administration of oHSVs.
More details of Novo Nordisk A/S’ phase III Select trial indicate that risk reductions in major adverse cardiovascular events were achieved regardless of age, gender, ethnicity and starting body mass index when obese and overweight patients were treated with Wegovy (semaglutide, 2.4 mg). Statistical significance was seen, however, only with the reduction of heart attacks and not other measures that were part of the trial.
For Verve Therapeutics Inc., the good news was the first human proof-of-concept data for a single-course in vivo base-editing treatment, presented at the American Heart Association Scientific Sessions over the weekend, showed treatment with VERVE-101 led to promising dose-dependent reductions in low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolemia. The bad news was to be found in the safety data for the 10 patients treated to date, which included a myocardial infarction in one patient deemed potentially related to treatment.
The blowup in phase II with Aclaris Pharmaceuticals Inc.’s oral MK2 inhibitor zunsemetinib (ATI-450) for moderate to severe rheumatoid arthritis (RA) sent shares (NASDAQ:ACRS) into a tailspin and sparked Wall Street speculation about the firm’s other mid-stage prospect. Wayne, Pa.-based Aclaris’ stock ended Nov. 13 at 64 cents, down $4.11, or 86%, after investors learned that ATI-450 missed the study’s primary and secondary endpoints. Development of the candidate, which was also under phase IIa investigation in psoriatic arthritis, will be stopped.
Nearly a year and a half after an interim analysis cast doubt on the future of Atara Biotherapeutics Inc.’s phase II study of ATA-188 in treating non-active progressive multiple sclerosis (PMS), the newly released primary analysis didn’t change much.
Lumos Pharma Inc.’s novel approach with LUM-201 in pediatric growth hormone deficiency paid off in top-line results, and the company is laying the groundwork for a phase III study next year. Pisit “Duke” Pitukcheewanont, senior vice president of global clinical development and medical affairs for Lumos, told BioWorld that the ability of LUM-201 to generate hormone at the normal range, promoting growth comparable to standard-of-care daily or weekly injections is “groundbreaking.”
While executives of Durect Corp. plugged “compelling” reduction in mortality from a phase IIb study testing DNMT inhibitor larsucosterol in severe alcohol-associated hepatitis and looked ahead to a potential registrational trial, investors focused on the fact that the study, called Ahfirm, fell short of statistical significance on both primary and secondary endpoints, sending shares (NASDAQ:DRRX) down 79%.
Otsuka Pharmaceutical Co. Ltd.’s sibeprenlimab (VIS-649) met the primary efficacy endpoint in a phase II trial for treating immunoglobulin A nephropathy (IgAN), demonstrating that 12 months of treatment resulted in significant reductions in proteinuria compared to placebo.
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