Ascletis Announces First Participants with Obesity or Overweight Dosed in Its U.S. 12-week Phase IIa Study Evaluating Once-Monthly Subcutaneous Depot Formulation of Small Molecule GLP-1R Agonist ASC30
28 juli, 02:15
Ascletis Announces First Participants with Obesity or Overweight Dosed in Its U.S. 12-week Phase IIa Study Evaluating Once-Monthly Subcutaneous Depot Formulation of Small Molecule GLP-1R Agonist ASC30
PR Newswire
HONG KONG, July 27, 2025
- First participants with obesity or overweight with at least one weight-related comorbidity have been dosed in a U.S. 12-week Phase IIa study with once-monthly subcutaneous (SQ) depot formulation of small m olecule GLP-1 receptoragonist ASC30.
- Ultra-long-acting SQ depot formulation of small molecule ASC30 demonstrated a 36-day half-life in participants with obesity in the Phase Ib study, supporting once monthly administration.
- Phase Ib study also demonstrated that compared to the trough concentration of ASC30 at D ay 29, the ultra-long-acting SQ depot formulation showed a peak-to-trough ratio less than 2:1.
- Topline data from the 12-week Phase IIa study of ASC30 once-monthly SQ depot formulation are expected in the first quarter of 2026.
HONG KONG , July 27, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the first participants with obesity or overweight with at least one weight-related comorbidity have been dosed in its U.S. 12-week Phase IIa study with once-monthly subcutaneous (SQ) depot formulation of small molecule GLP-1 receptor (GLP-1R) agonist ASC30 for the treatment of obesity ( NCT06679959 ).
In the completed U.S. Phase Ib single ascending dose (SAD) stud y, th e ultra-long-acting SQ depot formulation of small molecule ASC30 demonstrated a 36-day half-life in participants with obesity, supporting once monthly administration ( Press Release ). Furthermore, the U.S. Phase Ib SAD study demonstrated that compared to the trough concentration of ASC30 at Day 29, the ultra-long-acting SQ depot formulation showed a peak-to-trough ratio less than 2:1. The proprietary SQ depot slow-release formulation of ASC30 was developed by Ascletis' Ultra-Long-Acting Platform (ULAP). Utilizing this innovative platform, Ascletis has successfully designed and developed two small molecule SQ compounds for obesity with half-lives of 36 days (ASC30) and 40 days (ASC47) in participants with obesity. Ascletis' ULAP technology does not have the limitations of albumin-dependent half-life extension technology, currently being applied to many incretins, which limits half-life extension to the half-life of albumin (approximately 20 days).
In order to achieve acceptable tolerability for SQ dosing of incretin drugs, the peak-to-trough ratio during the intended dosing int erval should be equal to or less than 2:1. Th e peak-to-trough ratios of marketed semaglutide and tirzepatide are approximately 2:1 during their intended dosing interval. Achieving optimal tolerability of a once-monthly SQ incretin requires a half-life equal to or greater than the intended dosing interval. "A half-life less than the intended dosing interval will most likely result in a peak-to-trough ratio much greater than 2:1, negatively impacting tolerability. Among incretin drugs in clinical development or with market authorizations, ASC30 once-monthly SQ depot formulation is the only once-a-month incretin with a half-life greater than the intended dosing interval." said Jinzi Jason Wu , Ph.D., Founder, Chairman and CEO of Ascletis.
The Phase IIa study of ASC30 once-monthly SQ depot formulation is a 12-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the safety, tolerability and efficacy in participants with obesity (body mass index (BMI) ≥ 30 kg/m 2 ) or overweight (BMI ≥ 27 kg/m 2 but < 30 kg/m 2 ) with at least one weight-related comorbidity. The study consists of three cohorts of different doses, with a total of approximately 65 participants. Topline data are expected in the first quarter of 2026.
ASC30 was discovered and developed in-house at Ascletis as a first and only investigational small molecule GLP-1R biased agonist designed to be dosed once daily orally and once monthly subcutaneously for the treatment of obesity.
About ASC30
ASC30 is an investigational GLP-1R biased small molecule agonist and has unique and differentiated properties that enable the same small molecule for both oral tablet and subcutaneous injection administrations. ASC30 is a new chemical entity (NCE), with U.S. and global compound patent protection until 2044 without patent extensions.
About Ascletis Pharma Inc.
Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) Platform and Ultra-Long-Acting Platform (ULAP), Ascletis has developed multiple drug candidates in-house, including its lead program, ASC30, a small molecule GLP-1R agonist in development as a once-daily oral tablet and once-monthly subcutaneous injection for weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).
To learn more about Ascletis, please visit www.ascletis.com .
Contact：
Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com
Ascletis Pharma Inc. PR and IR teams
+86-181-0650-9129 ( China )
pr@ascletis.com
ir@ascletis.com
SOURCE Ascletis Pharma Inc.
Ascletis Announces First Participants with Obesity or Overweight Dosed in Its U.S. 12-week Phase IIa Study Evaluating Once-Monthly Subcutaneous Depot Formulation of Small Molecule GLP-1R Agonist ASC30
28 juli, 02:15
Ascletis Announces First Participants with Obesity or Overweight Dosed in Its U.S. 12-week Phase IIa Study Evaluating Once-Monthly Subcutaneous Depot Formulation of Small Molecule GLP-1R Agonist ASC30
PR Newswire
HONG KONG, July 27, 2025
- First participants with obesity or overweight with at least one weight-related comorbidity have been dosed in a U.S. 12-week Phase IIa study with once-monthly subcutaneous (SQ) depot formulation of small m olecule GLP-1 receptoragonist ASC30.
- Ultra-long-acting SQ depot formulation of small molecule ASC30 demonstrated a 36-day half-life in participants with obesity in the Phase Ib study, supporting once monthly administration.
- Phase Ib study also demonstrated that compared to the trough concentration of ASC30 at D ay 29, the ultra-long-acting SQ depot formulation showed a peak-to-trough ratio less than 2:1.
- Topline data from the 12-week Phase IIa study of ASC30 once-monthly SQ depot formulation are expected in the first quarter of 2026.
HONG KONG , July 27, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the first participants with obesity or overweight with at least one weight-related comorbidity have been dosed in its U.S. 12-week Phase IIa study with once-monthly subcutaneous (SQ) depot formulation of small molecule GLP-1 receptor (GLP-1R) agonist ASC30 for the treatment of obesity ( NCT06679959 ).
In the completed U.S. Phase Ib single ascending dose (SAD) stud y, th e ultra-long-acting SQ depot formulation of small molecule ASC30 demonstrated a 36-day half-life in participants with obesity, supporting once monthly administration ( Press Release ). Furthermore, the U.S. Phase Ib SAD study demonstrated that compared to the trough concentration of ASC30 at Day 29, the ultra-long-acting SQ depot formulation showed a peak-to-trough ratio less than 2:1. The proprietary SQ depot slow-release formulation of ASC30 was developed by Ascletis' Ultra-Long-Acting Platform (ULAP). Utilizing this innovative platform, Ascletis has successfully designed and developed two small molecule SQ compounds for obesity with half-lives of 36 days (ASC30) and 40 days (ASC47) in participants with obesity. Ascletis' ULAP technology does not have the limitations of albumin-dependent half-life extension technology, currently being applied to many incretins, which limits half-life extension to the half-life of albumin (approximately 20 days).
In order to achieve acceptable tolerability for SQ dosing of incretin drugs, the peak-to-trough ratio during the intended dosing int erval should be equal to or less than 2:1. Th e peak-to-trough ratios of marketed semaglutide and tirzepatide are approximately 2:1 during their intended dosing interval. Achieving optimal tolerability of a once-monthly SQ incretin requires a half-life equal to or greater than the intended dosing interval. "A half-life less than the intended dosing interval will most likely result in a peak-to-trough ratio much greater than 2:1, negatively impacting tolerability. Among incretin drugs in clinical development or with market authorizations, ASC30 once-monthly SQ depot formulation is the only once-a-month incretin with a half-life greater than the intended dosing interval." said Jinzi Jason Wu , Ph.D., Founder, Chairman and CEO of Ascletis.
The Phase IIa study of ASC30 once-monthly SQ depot formulation is a 12-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the safety, tolerability and efficacy in participants with obesity (body mass index (BMI) ≥ 30 kg/m 2 ) or overweight (BMI ≥ 27 kg/m 2 but < 30 kg/m 2 ) with at least one weight-related comorbidity. The study consists of three cohorts of different doses, with a total of approximately 65 participants. Topline data are expected in the first quarter of 2026.
ASC30 was discovered and developed in-house at Ascletis as a first and only investigational small molecule GLP-1R biased agonist designed to be dosed once daily orally and once monthly subcutaneously for the treatment of obesity.
About ASC30
ASC30 is an investigational GLP-1R biased small molecule agonist and has unique and differentiated properties that enable the same small molecule for both oral tablet and subcutaneous injection administrations. ASC30 is a new chemical entity (NCE), with U.S. and global compound patent protection until 2044 without patent extensions.
About Ascletis Pharma Inc.
Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) Platform and Ultra-Long-Acting Platform (ULAP), Ascletis has developed multiple drug candidates in-house, including its lead program, ASC30, a small molecule GLP-1R agonist in development as a once-daily oral tablet and once-monthly subcutaneous injection for weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).
To learn more about Ascletis, please visit www.ascletis.com .
Contact：
Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com
Ascletis Pharma Inc. PR and IR teams
+86-181-0650-9129 ( China )
pr@ascletis.com
ir@ascletis.com
SOURCE Ascletis Pharma Inc.
Handelskrig
Apple
Analys
Handelskrig
Apple
Analys
Marknadsöversikt
1 DAG %
Senast
1 mån
Privatekonomi med Placeras expert
Affärsvärlden
