QL Biopharm Presents Phase 1c Study Results on Monthly GLP-1RA ZT002 at EASD 2024

Beijing QL Biopharmaceutical Co., Ltd. ("QL Biopharm"), a clinical-stage biopharmaceutical company specializing in innovative biologic drugs for metabolic diseases, has announced promising Phase 1c clinical data for its lead drug candidate, ZT002, at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024 in Madrid, Spain.

The presentation, titled 'ZT002, a novel ultra long-acting GLP-1 receptor agonist in adults with overweight or obesity: A randomized, placebo-controlled, multiple ascending dose phase 1c study,' detailed the results of a study on ZT002, an ultra long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA) designed for obesity treatment with monthly subcutaneous injections.

The study involved 28 overweight or obese patients divided into two cohorts. Participants were randomly assigned to receive biweekly (Q2W) subcutaneous injections of ZT002 (either 40 mg or 80 mg; 10 patients each) or a placebo (4 patients each) for 12 or 14 weeks, depending on the dose. The primary objectives were to assess safety and tolerability, while secondary objectives included pharmacokinetics, pharmacodynamics, and immunogenicity. All endpoints were successfully met.

Following this period, a 6-week off-drug phase was conducted to study pharmacokinetics, succeeded by an open-label extension (Part B). In this extension, patients from the 80 mg Q2W cohort voluntarily participated in an additional 12 weeks of treatment with a 120 mg dose of ZT002 administered once monthly (Q4W). The primary and secondary endpoints remained the same and were all achieved.

Key findings from the presentation include:

- ZT002 was found to be safe and well tolerated across all doses, aligning with the tolerability profile typical of the GLP-1RA class. Tolerability improved over time for both biweekly and monthly dosing schedules.
- Most adverse events (AEs) were mild to moderate, with no serious AEs reported in the ZT002 treatment groups. Gastrointestinal issues were the most common treatment-emergent adverse events, primarily occurring during dose escalation and subsiding once the target dose was reached.
- The GI adverse event profile for monthly dosing in Part B was similar to that for biweekly dosing in Part A.
- Statistically significant weight reduction was observed with ZT002 compared to placebo:
- A 13.0% reduction in body weight was seen from baseline to 14 weeks with ZT002 80 mg Q2W (p<0.001 vs. placebo's 1.7% reduction).
- A 9.6% reduction in body weight was observed from baseline to 12 weeks with ZT002 40 mg Q2W (p<0.001 vs. placebo's 0.8% reduction).
- In Part B, a 17.1% reduction in body weight from baseline was noted at 30 weeks with once-monthly 120 mg dosing of ZT002 following a 6-week off-drug period.
- All doses of ZT002 demonstrated improvements in cardiometabolic parameters, including blood pressure, waist circumference, insulin sensitivity, lipid profiles, and liver enzyme levels.

These results suggest that ZT002 has significant potential as a monthly treatment for obesity. Consequently, a Phase 2 program to evaluate ZT002 for chronic weight management has been initiated in China, with plans for regulatory discussions with the U.S. FDA to advance the program outside China.

Dr. Zhang Xujia, Ph.D., Founder, Chairman, and CEO of QL Biopharm, expressed satisfaction with the data, highlighting ZT002's promising clinical profile and the advantage of monthly dosing. This simplifies the treatment regimen for patients with obesity, and QL Biopharm looks forward to advancing the Phase 2 program and providing further updates.

QL Biopharm, a clinical-stage biopharmaceutical company, focuses on developing novel peptide therapeutics for metabolic diseases, leveraging a proprietary E. coli manufacturing process. The company's lead drug candidate, ZT002, is currently in Phase 2 studies for obesity and Phase 1 for type 2 diabetes, showing potential for once-monthly dosing with significant weight loss and tolerability.