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Amylyx shares good news for its investigational GLP-1 blocker; Definium announces positive data for its LSD-based therapy in anxiety; Summit/Akeso’s ivonescimab shows degrading survival benefits; patients treated with Neurocrine’s Prader-Willi drug experience serious adverse events; and Eli Lilly cracks down on the black market for next-gen obesity asset retatrutide. > Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart > Watch on YouTube Amylyx’s GLP-1 blocker is showing promise in treating low blood sugar in patients who have undergone weight loss surgery. In patients with post-bariatric hypoglycemia, avexitide led to a 55% reduction in the composite rate of level 2 and level 3 hypoglycemic events, beating analyst expectations. It’s a real redemption story for the company, which two years ago pulled its ALS drug Relyvrio from the market after it failed to show efficacy in a Phase 3 trial. Meanwhile, the path to the U.S. market for Summit Therapeutics’ Akeso-partnered VEGF/PD-1 bispecific antibody ivonescimab gets more complicated with every readout. Last week, ivonescimab was approved by Chinese regulators for squamous non-small cell lung cancer, but the label published along with the approval showed a degrading progression-free survival benefit in this population, raising concern among investors that the ongoing Phase 3 HARMONi-3—intended to support U.S. accelerated approval—may not show substantial benefit. Definium’s single-dose oral LSD candidate, which has already read out in a study for major depressive disorder, notched a late-stage win in generalized anxiety disorder last week. In a 12-week trial, the asset significantly lowered anxiety symptoms based on an industry scale, with a reduction rate that even came in slightly higher than what analysts had expected. As psychedelics near the market, drugmakers around the world look to position themselves as the go-to manufacturers for the U.S. If you missed it, sign up for ClinicaSpace to receive a special edition focused on the psychedelics space. Also last week, the Prader-Willi community got some bad news as Neurocrine Biosciences reported that patients taking the approved drug Vykat experienced severe adverse events, including seven deaths . The same day, Aardvark Therapeutics terminated a Phase 3 trial of ARD-101 in Prader-Willi after concerning cardiac concerns arose earlier this year. Finally, Eli Lilly is cracking down on the black market for its next-generation obesity drug retatrutide. The Indianapolis pharma has sued six U.S. entities and has also referred more than 200 other players to U.S. authorities and reported over 14,000 websites, social media posts, advertisements and online listings spanning more than 100 countries for illegal retatrutide sales. Lilly called the situation an “urgent public health crisis” and said it has been aided by cross-border “criminal networks.”

Shares in Amylyx Pharmaceuticals jumped more than 30% on Tuesday after the company reported that a Phase III study of avexitide in people with post-bariatric hypoglycaemia (PBH) met its primary endpoint, setting up an FDA filing for the GLP-1 receptor antagonist by the end of the year. "Together with the positive data generated across five previous clinical trials of avexitide in PBH, we believe the LUCIDITY results bring us one step closer to potentially delivering the first approved treatment for people living with PBH," said Chief Medical Officer Camille Bedrosian. The LUCIDITY trial enrolled 78 adults with PBH following Roux-en-Y gastric bypass surgery, with participants randomised to receive either avexitide subcutaneously once daily or placebo. Top-line results showed that the study met its FDA-agreed-upon primary endpoint by demonstrating a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycaemic events compared to placebo through week 16. Ahead of the readout, analysts at H.C. Wainwright analysts had ⁠forecast a 35% to 50% reduction as the "plausible band" for ​an encouraging outcome. In addition, Amylyx said the study met all secondary goals, demonstrating consistent, highly statistically significant and clinically meaningful reductions in Level 2 hypoglycaemic events by self-monitoring of blood glucose, Level 2 hypoglycaemic events by continuous glucose monitoring and Level 3 hypoglycaemic events. "Preventing even one Level 2 or Level 3 event is medically meaningful. I am excited by the LUCIDITY results announced today and the potential to have the first treatment for patients with PBH," said principal investigator Marilyn Tan. Amylyx noted that avexitide was generally well-tolerated in the study with the most common adverse events being diarrhoea, injection site erythema and injection site bruising. The company added that there were no changes in body weight observed in either the avexitide or placebo groups in LUCIDITY, with further data to be presented at an upcoming medical meeting. Avexitide came into Amylyx's hands through a 2024 deal with Eiger BioPharmaceuticals as the company moved into the metabolic space following the withdrawal from the market of its amyotrophic lateral sclerosis drug Relyvrio (sodium phenylbutyrate/taurursodiol). The content above comes from the network. if any infringement, please contact us to modify.