– ZT002 was safe and well tolerated in both biweekly and monthly dosing arms in patients with overweight or obesity with a tolerability profile aligned with the GLP-1RA class
– The open-label extension with ZT002 120 mg, once-monthly, showed 17.1% reduction in body weight at 30 weeks
BEIJING, China I September 12, 2024 I Beijing QL Biopharmaceutical Co., Ltd. (“QL Biopharm” or the “Company”), a clinical stage biopharmaceutical company developing innovative biologic drugs for the treatment of metabolic diseases, today announces Phase 1c clinical data for its lead drug candidate ZT002 was presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024, 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’ highlighted recent findings on QL Biopharm’s lead drug candidate ZT002 – a novel ultra long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA) in development for obesity with monthly subcutaneous administration.
The study enrolled 28 overweight/obese patients in Part A in two cohorts. Eligible participants were randomly assigned to receive biweekly (Q2W) subcutaneous injections of ZT002 (dose escalated to 40 or 80 mg; n=10+10) or matched placebo (n=4+4) for a 12- or 14- week treatment period, in the 40 mg and 80 mg dose arms, respectively. The primary endpoints were safety and tolerability, and secondary endpoints were pharmacokinetics, pharmacodynamics, and immunogenicity. All endpoints were met. Following a 6-week off-drug period, for assessment of pharmacokinetics, Part A was followed by an open-label extension (Part B). In this extension patients from the ZT002 80 mg Q2W cohort voluntarily participated in an additional 12 weeks of treatment with a once-monthly (Q4W) administration of ZT002 120 mg (n=8). The primary endpoints were safety and tolerability, and secondary endpoints were pharmacokinetics, pharmacodynamics, and immunogenicity. All endpoints were met.
Key conclusions from today’s presentation are outlined below:
- ZT002 was considered safe and well tolerated across the investigated dose range, with a favorable tolerability profile aligned with the GLP-1RA class. The tolerability with both Q2W and Q4W dosing improved over time.
- The majority of adverse events (AEs) were mild or moderate in severity, no serious AEs were reported in the ZT002 treatment groups.
- Gastrointestinal (GI) treatment emergent adverse events were consistent with the GLP-1RA class;
- Most common treatment-related adverse events were nausea, vomiting, and diarrhea, occurring primarily during dose escalation and decreasing once target dose was reached.
- The GI AE profile of monthly dosing in Part B appeared similar to biweekly dosing in Part A
- In Part A, ZT002 demonstrated statistically significantly higher weight reduction compared to placebo with
- 13.0% body weight reduction from baseline to 14 weeks with ZT002 80 mg Q2W (p<0.001 vs placebo 1.7% body weight reduction).
- 9.6% body weight reduction from baseline to 12 weeks with ZT002 40 mg Q2W (p<0.001 vs placebo 0.8% body weight reduction).
- In Part B, a 17.1% body weight reduction from baseline was seen at 30 weeks, when further administering ZT002 120 mg once-monthly (after a 6-week off-drug period).
- All doses of ZT002 showed improved cardiometabolic parameters including blood pressure, waist circumference, insulin sensitivity, lipids, and liver enzyme levels.
- The results support further clinical investigation of ZT002 dosed monthly as a treatment for obesity. A Phase 2 program evaluating ZT002 for chronic weight management has been initiated in China and regulatory interaction is planned with U.S. FDA to advance the program outside China.
Dr. Zhang Xujia, Ph.D., Founder, Chairman and Chief Executive Officer of QL Biopharm said: “We are pleased to present data highlighting the potential of ZT002 and its promising clinical profile in obesity care. The additional advantage of monthly dosing simplifies life for patients living with obesity. We look forward to advancing the Phase 2 program for ZT002 in overweight and obesity and providing further updates in due course.”
Abstracts are available on the EASD website here, and on the QL Biopharm website here.
NOTES TO EDITORS
About QL Biopharm
QL Biopharm is a clinical-stage biopharmaceutical company focused on developing novel best-in-class peptide therapeutics for metabolic diseases. The Company leverages its proprietary E. coli manufacturing process enabling rapid and cost-effective scaling of manufacturing for high volume markets. The lead drug candidate, ZT002, is an ultra long-acting subcutaneously administered GLP-1 receptor agonist, currently in a Phase 2 study for obesity and in Phase 1 for type 2 diabetes. In Phase 1 studies, ZT002 demonstrated potential for once-monthly dosing with compelling weight loss and tolerability consistent with the GLP-1RA class. The Company is also advancing a broader portfolio of novel preclinical assets for the treatment of metabolic diseases, in addition to its biosimilar semaglutide program, currently in Phase 3. QL Biopharm is led by a team of pharma industry veterans with expertise in E. coli–based peptide manufacturing and the development of drugs for metabolic diseases. The Company is backed by leading professional life science investors.
For additional information, please visit https://qlbiopharm.com/
About EASD
The European Association for the Study of Diabetes e.V. (EASD) is a membership-based academic non-profit organization. It was founded in 1965 and its headquarters is based in Duesseldorf, Germany. The aims of the Association are to encourage and support research in the field of diabetes, the rapid diffusion of acquired knowledge and to facilitate its application.
SOURCE: Beijing QL Biopharmaceutical Co.
Post Views: 631
– ZT002 was safe and well tolerated in both biweekly and monthly dosing arms in patients with overweight or obesity with a tolerability profile aligned with the GLP-1RA class
– The open-label extension with ZT002 120 mg, once-monthly, showed 17.1% reduction in body weight at 30 weeks
BEIJING, China I September 12, 2024 I Beijing QL Biopharmaceutical Co., Ltd. (“QL Biopharm” or the “Company”), a clinical stage biopharmaceutical company developing innovative biologic drugs for the treatment of metabolic diseases, today announces Phase 1c clinical data for its lead drug candidate ZT002 was presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024, 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’ highlighted recent findings on QL Biopharm’s lead drug candidate ZT002 – a novel ultra long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA) in development for obesity with monthly subcutaneous administration.
The study enrolled 28 overweight/obese patients in Part A in two cohorts. Eligible participants were randomly assigned to receive biweekly (Q2W) subcutaneous injections of ZT002 (dose escalated to 40 or 80 mg; n=10+10) or matched placebo (n=4+4) for a 12- or 14- week treatment period, in the 40 mg and 80 mg dose arms, respectively. The primary endpoints were safety and tolerability, and secondary endpoints were pharmacokinetics, pharmacodynamics, and immunogenicity. All endpoints were met. Following a 6-week off-drug period, for assessment of pharmacokinetics, Part A was followed by an open-label extension (Part B). In this extension patients from the ZT002 80 mg Q2W cohort voluntarily participated in an additional 12 weeks of treatment with a once-monthly (Q4W) administration of ZT002 120 mg (n=8). The primary endpoints were safety and tolerability, and secondary endpoints were pharmacokinetics, pharmacodynamics, and immunogenicity. All endpoints were met.
Key conclusions from today’s presentation are outlined below:
- ZT002 was considered safe and well tolerated across the investigated dose range, with a favorable tolerability profile aligned with the GLP-1RA class. The tolerability with both Q2W and Q4W dosing improved over time.
- The majority of adverse events (AEs) were mild or moderate in severity, no serious AEs were reported in the ZT002 treatment groups.
- Gastrointestinal (GI) treatment emergent adverse events were consistent with the GLP-1RA class;
- Most common treatment-related adverse events were nausea, vomiting, and diarrhea, occurring primarily during dose escalation and decreasing once target dose was reached.
- The GI AE profile of monthly dosing in Part B appeared similar to biweekly dosing in Part A
- In Part A, ZT002 demonstrated statistically significantly higher weight reduction compared to placebo with
- 13.0% body weight reduction from baseline to 14 weeks with ZT002 80 mg Q2W (p<0.001 vs placebo 1.7% body weight reduction).
- 9.6% body weight reduction from baseline to 12 weeks with ZT002 40 mg Q2W (p<0.001 vs placebo 0.8% body weight reduction).
- In Part B, a 17.1% body weight reduction from baseline was seen at 30 weeks, when further administering ZT002 120 mg once-monthly (after a 6-week off-drug period).
- All doses of ZT002 showed improved cardiometabolic parameters including blood pressure, waist circumference, insulin sensitivity, lipids, and liver enzyme levels.
- The results support further clinical investigation of ZT002 dosed monthly as a treatment for obesity. A Phase 2 program evaluating ZT002 for chronic weight management has been initiated in China and regulatory interaction is planned with U.S. FDA to advance the program outside China.
Dr. Zhang Xujia, Ph.D., Founder, Chairman and Chief Executive Officer of QL Biopharm said: “We are pleased to present data highlighting the potential of ZT002 and its promising clinical profile in obesity care. The additional advantage of monthly dosing simplifies life for patients living with obesity. We look forward to advancing the Phase 2 program for ZT002 in overweight and obesity and providing further updates in due course.”
Abstracts are available on the EASD website here, and on the QL Biopharm website here.
NOTES TO EDITORS
About QL Biopharm
QL Biopharm is a clinical-stage biopharmaceutical company focused on developing novel best-in-class peptide therapeutics for metabolic diseases. The Company leverages its proprietary E. coli manufacturing process enabling rapid and cost-effective scaling of manufacturing for high volume markets. The lead drug candidate, ZT002, is an ultra long-acting subcutaneously administered GLP-1 receptor agonist, currently in a Phase 2 study for obesity and in Phase 1 for type 2 diabetes. In Phase 1 studies, ZT002 demonstrated potential for once-monthly dosing with compelling weight loss and tolerability consistent with the GLP-1RA class. The Company is also advancing a broader portfolio of novel preclinical assets for the treatment of metabolic diseases, in addition to its biosimilar semaglutide program, currently in Phase 3. QL Biopharm is led by a team of pharma industry veterans with expertise in E. coli–based peptide manufacturing and the development of drugs for metabolic diseases. The Company is backed by leading professional life science investors.
For additional information, please visit https://qlbiopharm.com/
About EASD
The European Association for the Study of Diabetes e.V. (EASD) is a membership-based academic non-profit organization. It was founded in 1965 and its headquarters is based in Duesseldorf, Germany. The aims of the Association are to encourage and support research in the field of diabetes, the rapid diffusion of acquired knowledge and to facilitate its application.
SOURCE: Beijing QL Biopharmaceutical Co.
Post Views: 631
