Ascletis Completes Denifanstat (ASC40) Pre-NDA Consultation with China National Medical Products Administration
- Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo in a Phase III randomized, double-blind, placebo-controlled, multicenter clinical trial. HONG KONG, Oct. 14, 2025...
Ascletis Selects a Best-In-Class Once-Monthly Subcutaneously Administered GLP-1R/GIPR Dual Peptide Agonist, ASC35, for Clinical Development
- In head-to-head non-human primate (NHP) studies, average observed half-life of ASC35 was approximately 14 days, 6-fold longer than tirzepatide, which supports once-monthly subcutaneous (SQ) dosing in humans. - In head-to-head NHP studies, drug exposures of ASC35 intravenous (I.V.) and SQ admin...
Ascletis Announces ASC47 in Combination with Semaglutide Demonstrated Up to 56.2% Greater Relative Reduction in Body Weight in Participants with Obesity Compared to Semaglutide Monotherapy
- The gastrointestinal (GI) tolerability of ASC47 in combination with semaglutide was significantly better than placebo in combination with semaglutide (semaglutide monotherapy). The incidence of vomiting was 6.7% in ASC47 in combinationwith semaglutide group compared to 57.1% in the sem...
Ascletis Presented Phase III Study Results of First-in-Class FASN Inhibitor Denifanstat (ASC40) for Acne Treatment in the Late Breaking News Sessions of the European Academy of Dermatology and Venereology (EADV) Congress 2025
--Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne compared with placebo. --Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile. Treatment emergent adverse events (TEAEs)...
Ascletis Presented Results from Cohorts 1 and 2 of 28-day Multiple Ascending Dose Study of Its Oral Small Molecule GLP-1R Agonist ASC30 at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting
- ASC30 once-daily oral tablet demonstrated up to 6.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment. - ASC30 tablet's higher efficacy is supported by its higher oral drug exposures. - ASC30 is safe and well tolerated with only mild-...
Ascletis to Present 28-day Multiple Ascending Dose Study Results of Oral Small Molecule GLP-1R Agonist ASC30 at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting
- Ascletis to present data from the U.S. Phase Ib clinical study of ASC30 oral tablet in oral discussion - On track to report topline data from Phase IIa clinical study of ASC30 oral tablet in participants with obesity or overweight in the fourth quarter of 2025 HONG KONG, Sept. 2, 2025 /PRNe...
Ascletis Announces Favorable and Differentiated Pharmacokinetic Profile of ASC30 Oral Once-Daily Tablet in Its U.S. Phase Ib Multiple Ascending Dose Study
- ASC30 oral once-daily tablet demonstrated approximately 2.3-fold to 3.3-fold greater drug exposure than orforglipron in a cross-trial comparison. - Higher drug exposure and favorable tolerability profile positions ASC30 oral once-daily tablet favorably compared to orforglipron...
Ascletis Announces the Combination of ASC47 and ASC31, its Dual GLP-1R/GIPR Peptide Agonist, Demonstrated Significantly Greater Weight Loss Compared to the Combination of ASC47 and Tirzepatide in an Animal Model of Obesity
- Combination of a low dose of ASC47 with ASC31, a novel peptide agonist targeting bothGLP-1 receptor (GLP-1R) and GIP receptor (GIPR), resulted in a 44.8% reduction in body weight after 14 days of treatment in a diet-induced obese (DIO) mouse model. - Combination of a low dose of ASC47 with A...
Ascletis Announces ASC47, a Muscle-Preserving Weight Loss Drug Candidate for Treatment of Obesity, Demonstrated Greater Efficacy with Tirzepatide than Semaglutide in a Preclinical Model
- The combination of ASC47 low dose with tirzepatide in diet-induced obese (DIO) mice resulted in an 87% greater reduction in body weight compared to tirzepatide monotherapy. - ASC47 low dose in combination with tirzepatide demonstrated statistically significantly greater incre...
Ascletis Completes Enrollment in U.S. Phase IIa Study for Its Small Molecule Oral GLP-1R Agonist, ASC30, in Participants with Obesity or Overweight
- 13-week U.S. Phase IIa study is evaluating the efficacy, safety and tolerability of two oral formulations of ASC30, a once-daily tablet, in 125 participants with obesity or overweight. - All 125 participants enrolled in just over one month; topline data expected in the fourth ...
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
- First participants with obesity or overweight with at least one w eight-related comorbidity have been dosed in a U.S. 12-week Phase IIa study with once-monthly subcutaneous (SQ) depot formulation of small molecule GLP-1 receptor agonist ASC30. - Ultra-long-acting SQ depot for...
Ascletis Completes Dosing of All Participants in Its U.S. Clinical Study Combining Adipose-Targeted, Once-Monthly Injectable Small Molecule THRβ Agonist, ASC47, and Semaglutide for the Treatment of Obesity
- The combination study, conducted in the U.S., is designed to evaluate the safety, tolerability and preliminary efficacy at Day 29 of a single-dose of ultra-long-acting subcutaneously administered ASC47 (half-life up to 40 days) in combination with four doses of semaglutide (0.5 mg, onc...
Ascletis Announces First Participants with Obesity or Overweight Dosed in a U.S. 13-week Phase IIa Study of Small Molecule Oral GLP-1R Agonist ASC30
- First participants with obesity or overweight with at least one weight-r elatedcomorbidity have been dosed in a U.S. 13-week Phase IIa study of small m oleculeoral GLP-1 receptor agonist ASC30. - ASC30 oral once-daily tablet demonstrated up to 6.5% placebo-adjusted mean body weight reduction f...
Ascletis Announces Poster Presentations on the Study Results of ASC30 and ASC47 at the 85th Scientific Sessions of American Diabetes Association (ADA)
HONG KONG, June 8, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that poster presentations on preliminary studies of its oral small moleculeGLP-1 Receptor (GLP-1R) agonist ASC30 and adipose-targeted, muscle-preserving weight loss drug candidate ASC47 will be present...
Ascletis Announces First Participants Dosed in a U.S. Clinical Study Combining Adipose-Targeted, Once-Monthly Injectable Small Molecule THRβ Agonist, ASC47, and Semaglutide for the Treatment of Obesity
- The combination study is designed to evaluate the safety and preliminary efficacy of a single-dose of ultra-long-acting subcutaneously administered ASC47 in combination with four doses of semaglutide (0.5 mg, once-weekly) in participants with obesity. - Asan adipose-targeted, muscle-preserving...
Ascletis Announces Oral and Poster Presentations on ASC47, an Adipose-Targeted, Muscle-Preserving Weight Loss Drug Candidate for Obesity at the 32nd European Congress on Obesity
HONG KONG, May 6, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces oral and poster presentations on preliminary studies of ASC47, an adipose-targeted, muscle-preserving weight loss drug candidate for obesity, will be presented at the 32nd European Congress On Obesity (E...
Ascletis Announces Positive Topline Results of U.S. Phase Ib Multiple Ascending Dose Study of Small Molecule Oral GLP-1R Agonist ASC30 and Submission of 13-week Phase IIa Study Protocol to FDA
- ASC30 oral once-daily tablet demonstrated a 6.5% placebo-adjusted mean body weight reduction from baseline after four-week treatment using weekly doses with titrations of 2 mg, 10 mg, 20 mg, and 40 mg doses. - ASC30 oral once-daily tablet also demonstrated a 4.5% placebo-adjusted mean body we...
Ascletis Announces Positive Interim Results from Its U.S. Phase Ib Trial with ASC30, a Potentially First-in-Class Subcutaneous Injection Small Molecule GLP-1R Agonist
-Ultra-long-acting subcutaneous (SQ) injection formulation of small molecule ASC30 demonstrated a 36-day half-life in patients with obesity, supporting once monthly or less frequent administration. -As previously disclosed, oral tablet formulation of small molecule ASC30 demonstrated potentially ...
Ascletis Pharma to Host Obesity Portfolio Webinar on April 2, 2025
HONG KONG, March 20, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces it will host an Obesity Portfolio Webinar onApril 2, 2025 , from9:00 a.m. – 10:30 a.m. ET. The event will include a detailed discussion on Ascletis' obesity portfolio including exciting data about its...
Ascletis Announces Positive Topline Results of Phase Ib Studies of ASC47 Monotherapy in Australia and U.S. FDA Clearance of IND Application for ASC47 in Combination with Semaglutide
* ASC47, an adipose-targeted muscle-preserving weight loss drug candidate for the treatment of obesity, demonstrated a half-life of up to 26 days and 40 days, respectively, in Phase Ib single subcutaneous injection studies in healthy subjects with elevatedlow-density lipoprotein cholesterol (LD...
