Neurosense Therapeutics Ltd. failed to impress Wall Street with top-line data from its phase IIb study called Paradigm with PrimeC, a fixed-dose combination of ciprofloxacin and celecoxib, in amyotrophic lateral sclerosis.
Replimune Group Inc.’s lead candidate, RP-1 (vusolimogene oderparepvec), took a solid hit as it missed both primary endpoints in the Cerpass phase II study of skin cancer. Despite some better results from the study and good news from other studies along with a plan to drop some programs, the company’s stock still suffered.
Patients with end-stage pancreatic ductal adenocarcinoma achieved unprecedented survival rates after being treated with the Engeneic dream vector nanocells, with 88% of patients doubling the historical survival rates, Engeneic Ltd. co-CEO Jennifer MacDiarmid told BioWorld.
Positive top-line data from Eyepoint Pharmaceuticals Inc.’s phase II study of EYP-1901 and the selective tyrosine kinase inhibitor vorolanib for treating wet age-related macular degeneration (AMD) is challenging Regeneron Pharmaceuticals Inc.’s recently approved Eylea (aflibercept).
Altimmune Inc.’s peptide-based glucagon-like peptide-1/glucagon dual receptor agonist pemvidutide hiccupped in a phase I study earlier this year but has bounced back with top-line results from its phase II study in obesity. Results showed robust reductions in body mass index and serum lipids, along with improvements in blood pressure with no imbalances in cardiac events, arrhythmias or clinically meaningful increases in heart rate. The data showed liver-fat loss similar to Novo Nordisk A/S’ GLP-1 drug Wegovy (semaglutide).
Cellcentric's inobrodib, a novel drug with a distinct mechanism of action, shows promise in treating various hematological malignancies, as revealed in a recent publication in Cancer Cell.
Patients with end-stage pancreatic ductal adenocarcinoma achieved unprecedented survival rates after being treated with the Engeneic dream vector nanocells, with 88% of patients doubling the historical survival rates, Engeneic Ltd. co-CEO Jennifer MacDiarmid told BioWorld.
For the second time this week, a contract research organization has come under fire for trial-conduct issues – criticism leveled most recently by Biovie Inc., which saw its shares (NASDAQ:BIVI) tumble $3.03, or 60%, to end Nov. 29 at $1.96 on missed-endpoint data from the phase III trial testing Alzheimer’s disease prospect NE-3107. The data fell short of statistical significance due to site exclusions caused by what Biovie said were “significant good clinical practice violations and protocol deviations.”
Acelyrin Inc. said a vendor used by Fortrea Inc., a CRO the company used for its phase IIb/III study testing interleukin-17A inhibitor izokibep in psoriatic arthritis, incorrectly programmed the study’s protocol and created a dose sequencing error, resulting in some patients in two of the four dosing arms to randomly receive placebo and active treatment instead of the intended alternating pattern. The discovery has prompted a review of other studies involving the CRO, including a study that failed to reach statistical significance in September.
Argenx SE’s surprise phase III blowup with subcutaneous Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in the platelet disorder primary immune thrombocytopenia (ITP) – blamed on a higher-than-expected placebo response – had investors speculating about possible read-throughs to other indications.
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