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Kailera Therapeutics Announces Phase 1 Data for Ribupatide Injection
Kailera Therapeutics announced Phase 1 data for ribupatide injection, a GLP-1/GIP receptor dual agonist currently advancing through global Phase 3 clinical trials, presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes. In addition, partner Hengrui Pharma delivered four oral presentations highlighting clinical data from programs now in global development by Kailera, including ribupatide injection, oral small molecule GLP-1 receptor agonist safiglipron, also known as KAI-7535, and injectable GLP-1/GIP/glucagon receptor tri-agonist KAI-4729. Kailera's Phase 1 single-dose, crossover trial investigated the effect of injection site on the relative bioavailability and safety of ribupatide injection administered subcutaneously in adults living with obesity or overweight. Plasma drug exposure following subcutaneous ribupatide injection to the upper arm or thigh was similar to that observed following abdominal injection, supporting these sites as alternative injection locations. Ribupatide injection was generally well tolerated irrespective of injection site, with no new safety signals identified. Among four additional presentations on GLP-1 therapeutics from partner Hengrui Pharma, new Phase 1 findings for HRS-4729 provided an early look at the clinical profile of the investigational GLP-1/GIP/glucagon receptor tri-agonist in obesity. Ribupatide demonstrated a mean reduction in body weight of 16.7% and 38.4% mean reduction in liver fat content. HRS-4729 and ribupatide injection demonstrated favorable safety and tolerability data consistent with GLP-1-based treatments. Kailera plans to initiate a Phase 1 clinical trial of KAI-4729 outside of China in 2026, with data expected in 2027.
Kailera Therapeutics Completes Enrollment in KaiNETIC Clinical Trials
Kailera Therapeutics announced the completion of enrollment in the KaiNETIC global Phase 3 clinical program. The KaiNETIC program, which encompasses three trials - KaiNETIC-1, KaiNETIC-2, and KaiNETIC-3 - is evaluating ribupatide injection, an investigational once-weekly dual GLP-1/GIP receptor agonist peptide, for the treatment of people living with obesity or overweight.
Kailera Therapeutics Appoints Nur Nicholson as CTO
Kailera Therapeutics (KLRA) announced the appointment of Nur Nicholson as chief technology officer, effective August 31. She previously served as chief technical operations officer at Apellis (APLS).
Kailera Therapeutics Reports Positive Phase 3 Results for HRS-7535
Kailera Therapeutics announced positive topline results from two Phase 3 clinical trials conducted by its partner, Hengrui Pharma, evaluating the oral small molecule candidate HRS-7535, also known as KAI-7535. In the HARBOR-1 trial for obesity, the candidate achieved a mean weight loss of up to 10.9% at week 44 and 11.1% at week 50. In the OUTSTAND-2 trial for type 2 diabetes, the once-daily drug met its primary endpoint of non-inferiority to dapagliflozin, reducing blood sugar levels by up to 1.68% at week 32. Kailera is concurrently evaluating KAI-7535 in an ongoing global Phase 2 trial for obesity, with results expected in 2027. "The HRS-7535 Phase 3 results highlight the promise of oral small molecules as a treatment option for people living with obesity, with the potential to combine clinically meaningful weight loss with convenience, scalability, and accessibility," said Scott Wasserman, chief medical officer, Kailera.
Kailera Therapeutics Appoints Kathleen Tregoning as Chief Corporate Affairs Officer
Kailera Therapeutics announced the appointment of Kathleen Tregoning as chief corporate affairs officer. Kathleen previously served as chief corporate affairs officer and head of commercial strategy at Cerevel Therapeutics.
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