KAI-4729 Injectable / Kailera Therapeutics, Jiangsu Hengrui Pharma - LARVOL DELTA

Hengrui Medicine: HRS-4729 Injection Receives Approval Notice for Clinical Trial [Google translation] (Eastmoney.com) - "...approving the drug to conduct a Phase II clinical trial in adult patients with type 2 diabetes. HRS-4729 injection is a GLP-1R/GIPR/GCGR triple agonist independently developed by the company."

New P2 trial • Type 2 Diabetes Mellitus

KAI-4729, injectable GLP-1/GIP/glucagon receptor tri-agonist (GlobeNewswire) - "The MAD portion of Phase 1 trial of KAI-4729 enrolled 60 participants with a mean baseline body weight of 87.3 kg (192 lbs) and mean baseline body mass index (BMI) of 31.4 kg/m2...HRS-4729 demonstrated linear pharmacokinetics, with a half-life of approximately 4 to 5 days, supporting once-weekly dosing; In the MAD portion of the trial at Week 12, participants receiving multiple doses of 12 mg of HRS-4729 achieved a mean weight loss of up to 16.0% from baseline, compared to 5.4% with placebo...HRS-4729 demonstrated dose-dependent reduction in liver fat content as measured by magnetic resonance imaging proton density fat fraction; Hengrui intends to share the full HRS-4729 Phase 1 clinical trial data at an upcoming scientific conference; Hengrui plans to advance HRS-4729 to Phase 2 clinical trials including for the treatment of obesity and metabolic dysfunction-associated steatohepatitis (MASH) in China, and Kailera plans to initiate a Phase 1 clinical trial outside of..."

First-in-human • New P1 trial • New P2 trial • P1 data • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Kailera outlines plans for $528.5M IPO to support quartet of Chinese obesity assets (FierceBiotech) - "The filing also outlines how the proceeds will be used to develop Kailera’s obesity assets, including injectable ribupatide, oral ribupatide and KAI-7535...With IPO funding and existing cash, Kailera plans to allocate $625 million to support injectable ribupatide, funding three ongoing global phase 3 trials through the second quarter of 2028...The funds will be used for planned phase 3 trials beginning in the second quarter of 2028...KAI-7535, a once-daily injectable small-molecule GLP-1, will receive a $50 million boost following the IPO...Kailera’s fourth obesity asset, KAI-4729—a once-weekly injectable GLP-1—will also benefit from the funding and is currently in a phase 1 trial in China."

Financing • New P3 trial • Trial status • Obesity

Kailera Therapeutics Announces $600 Million Series B Financing to Further Advance Pipeline of Next-Generation Therapies for the Treatment of Obesity (GlobeNewswire) - "The financing will be fully funded at closing and will support the advancement of Kailera’s leading obesity portfolio, including a global Phase 3 clinical program of Kailera’s lead candidate KAI-9531, an injectable dual GLP-1/GIP receptor agonist with potentially best-in-category weight loss...The Phase 3 program will include two trials in adults living with obesity or overweight with comorbidities, with and without type 2 diabetes, and an additional trial in adults living with a BMI of 35 or higher...'We look forward to starting our global Phase 3 trials of KAI-9531 by the end of this year'....The financing will also advance KAI-7535..."

Financing • New P3 trial • Obesity • Type 2 Diabetes Mellitus