Ascletis Pharma, Inc.

HONG KONG, June 8, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that poster presentations on preliminary studies of its oral small molecule GLP-1 Receptor (GLP-1R) agonist ASC30 and adipose-targeted, muscle-preserving weight loss drug candidate ASC47 will be presented at the 85th Scientific Sessions of American Diabetes Association (ADA) in Chicago, U.S. Details of the Poster Presentations Poster Number: 750-P Abstract Title: ASC30, an Oral GLP-1R Biased Small Molecule Agonist in Participants with Obesity—A First-in-Human Single Ascending Dose Study Session Type: General Poster Session Location: Poster Hall (Hall F1) Presentation Time: Sunday Jun 22, 2025 12:30 PM - 1:30 PM (Chicago Time), i.e., Monday Jun 23, 2025 1:30 AM - 2:30 AM (Beijing Time) Poster Number: 847-P Abstract Title: ASC47, a Muscle-Preserving Weight Loss Drug Candidate for Obesity, in Combination with Semaglutide, Demonstrated Superior Weight Loss to Semaglutide Monotherapy in a Preclinical Model Session Type: General Poster Session Location: Poster Hall (Hall F1) Presentation Time: Sunday Jun 22, 2025 12:30 PM - 1:30 PM (Chicago Time), i.e., Monday Jun 23, 2025 1:30 AM - 2:30 AM (Beijing Time) 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. About ASC47 ASC47 is an adipose-targeted, ultra-long-acting subcutaneously (SQ) injected thyroid hormone receptor beta (THRβ) selective small molecule agonist, discovered and developed in-house at Ascletis. ASC47 possesses unique and differentiated properties to enable adipose targeting, resulting in dose-dependent high drug concentrations in the adipose tissue. Topline data from its Phase Ib single subcutaneous injection studies in Australia in participants with elevated low-density lipoprotein cholesterol (LDL-C) (NCT06427590) have been released. The Phase I clinical trial of ASC47 in combination with semaglutide for the treatment of obesity (NCT06972992) is ongoing in the U.S., and the first participants were dosed in May 2025. About the American Diabetes Association (ADA) Established in 1940, the American Diabetes Association (ADA) is dedicated to preventing and curing diabetes and to improving the lives of all people affected by diabetes. It has grown into one of the foremost nonprofit organizations in diabetes advocacy around the world. Its annual Scientific Sessions set the agenda for clinical practice and research innovation. The 85th Scientific Sessions of ADA will be held in Chicago, U.S. from June 20 to 23, 2025. About Ascletis Pharma Inc. Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on metabolic diseases by addressing unmet medical needs from a global perspective. Ascletis has multiple clinical stage drug candidates in its metabolic disease pipeline. For more information, please visit . Contact： Peter Vozzo ICR Healthcare 443-231-0505 (U.S.) [email protected] Ascletis Pharma Inc. PR and IR teams +86-181-0650-9129 (China) [email protected] [email protected] SOURCE Ascletis Pharma Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Today, a brief rundown of news involving Otsuka Pharmaceutical and Arvinas, as well as updates from Regenxbio, Vigil Neuroscience and Sagimet Biosciences that you may have missed.Vera Therapeutics lost nearly a third of its market value Friday after Otsuka Pharmaceutical presented late-stage study data on a rival drug its developing for the kidney disease IgA nephropathy. At a medical meeting, Otsuka said its therapy, sibeprenlimab, led to a 51% reduction in proteinuria, a key marker of kidney health, after nine months of treatment. Though cross-trial comparisons can be misleading, Veras therapy led to a 42% reduction in proteinuria compared to placebo at a similar timepoint in its own Phase 3 study, causing investors to sell off company shares. Still, some analysts defended Vera. Jefferies Farzin Haque cautioned not to overinterpret the data and argued the two datasets are not clinically or statistically different for commercial uptake. The Food and Drug Administration could approve Otsukas drug by Nov. 28. On Monday, Vera said it intends to file an accelerated approval application in the fourth quarter. Ben FidlerArvinas and partner Pfizer have filed for a U.S. approval of their experimental protein-degrading drug for breast cancer, Arvinas said Friday. The two submitted the therapy,vepdegestrant, for use in people with estrogen-receptor positive, HER2 negative breast cancer and a mutation in the ESR1 gene. The application is based on Phase 3 datapresented at the American Society of Clinical Oncology meeting this week showing the drug held tumors in check longer than a standard treatment.That benefit was modest, however, and wasnt observed in the overall study population. Delilah AlvaradoRegenxbio released new data Thursday showing a potential impact on muscle function among Duchenne muscular dystrophy patients who received its experimental gene therapy in an early-stage clinical trial. Regenxbio said those given the dose its using in pivotal testing outperformed how historical data suggests they might on multiple widely used assessments of functional benefits. Still, shares fell by double digits, as some key information was missing from the update, the treatments effects appear to be plateauing and there is concern the data may not be strong enough to support an accelerated approval, wrote Jefferies analyst Maury Raycroft. Regenxbio expects to report pivotal data next year and has said it intends to seek a speedy approval afterwards, based on the therapys ability to produce a tiny version of a muscle-protecting protein. Ben FidlerVigil Neuroscience reported Wednesday the failure of a mid-stage trial meant to prove its most advanced drug works as intended. The study enrolled 20 people with ALSP, a rare disorder hallmarked by the erosion of white matter in the brain. All participants received Vigils drug, VGL101, which is designed to boost the TREM2 proteins that help control inflammation in the brain. The company said that while showing favorable safety and tolerability, its treatment had no beneficial effects on important markers of effectiveness or biological activity. As such, a separate, so-called long-term extension study is being discontinued. Sanofi is in the process of acquiring Vigil for access to a different TREM2-targeting medicine. Per terms of that deal, rights to VGL101 will be returned to its original licensor, Amgen. Jacob BellShares of Sagimet Biosciences have climbed nearly 40% since partner Ascletis Bioscience on Wednesday reported the companys drug denifanstat succeeded in a Phase 3 trial in China in people with moderate-to-severe acne. The drug produced compelling efficacy in the trial with only mild-to-moderate side effects, which could have positive implications for its ability to treat metabolic dysfunction-associated steatohepatitis, Leerink Partners analyst Thomas Smith wrote in a research note. A 2019 partnership handed Ascletis rights in greater China to denifanstat. Sagimet could receive up to $122 million in future payments, as well as sales royalties, if the drug is approved. Ben Fidler '

The idea behind denifanstat is to decrease cytokine secretion in order to inhibit the production of facial sebum.\n Ascletis Pharma’s acne pill has scored a phase 3 win, leading the Chinese biotech to claim the Sagimet Biosciences-sourced drug can hold its own against FDA-approved products like Seysara and doxycycline.The Chinese study saw 480 patients with moderate to severe acne vulgaris receive either a once-daily 50-mg dose of the oral fatty acid synthase inhibitor denifanstat or placebo for 12 weeks. The trial hit all three of its primary endpoints, including a 18.6% placebo-adjusted increase in the proportion of patients who achieved success as defined by a skin clearance score.Specifically, 33.2% of patients receiving denifanstat were assessed as having clear or almost clear skin at Week 12, compared to 14.6% of patients on placebo.The average reduction in skin lesions in the denifanstat group was 57.4% compared to 35.4% for those on placebo. When it came to a reduction in inflammatory lesions, the drop was 63.5% and 43.2%, respectively.While the trial was not designed to make head-to-head comparisons with existing acne products, Ascletis laid out its data alongside past results for potential competitors. This included comparing denifanstat’s 18.6% placebo-adjusted treatment success to 9.4% for Almirall’s Seysara, doxycycline’s 6.7% and 11.6% for clascoterone cream.Ascletis pointed to these comparisons as evidence that denifanstat “has the potential to be a first-in-class, once-daily, oral acne therapeutic, potentially offering both exceptional efficacy and patient compliance with a favorable safety and tolerability profile.”As an oral option, Ascletis also hopes denifanstat could ensure better adherence from patients than the current crop of topical treatments.When it came to safety, the denifanstat and placebo cohorts had a similar profile, the biotech said. The only treatment-related adverse events that affected slightly more than 5% of patients in the denifanstat arm were dry skin and dry eye. The idea behind denifanstat is to decrease cytokine secretion in order to inhibit the production of facial sebum, which is an underlying cause of acne. It means that, unlike some other acne treatments, denifanstat doesn’t have the potential to lead to antibiotic resistance or the off-target effects that can be seen with tetracycline antibiotics, Ascletis said.“We are extremely pleased with the topline results of our phase 3 trial,” Ascletis CEO Jinzi Jason Wu, Ph.D., said in the release.“Denifanstat tablets demonstrated impressive efficacy beyond treatment success, showing significant reductions in total lesion count, inflammatory lesion count, and non-inflammatory lesion count,” Wu added. “We are excited to be submitting this innovative treatment with the China National Medical Products Administration soon.”Ascletis licensed the China rights to denifanstat from Sagimet back in 2019 with the initial aim of exploring the drug in a liver disease called metabolic dysfunction-associated steatohepatitis. Work on this indication appears to have stalled, with Ascletis stating in March that the company will “make further assessment and seek opportunities to maximize the value of this program.”Antiviral, cancer and liver disease drug candidates were central to Ascletis’ strategy when the company went public in 2018. However, the biotech suffered setbacks in the clinic in its original core areas, including axing hepatitis B and liver disease programs. More recently, Ascletis has unveiled and quickly advanced a weight loss pipeline that features oral and subcutaneous formulations of a GLP-1 receptor agonist, leading the biotech to formalize its pivot to metabolic disease earlier this year.