Ascletis Announces Clinical Development of ASC36 for Obesity Management

ASC36: A New Hope in Obesity Treatment

Ascletis Pharma Inc., a biotechnology company focused on developing innovative treatments for metabolic diseases, proudly announces its selection of ASC36, an oral amylin receptor peptide agonist, for clinical development aimed at addressing obesity.

Utilizing their proprietary Peptide Oral Transport Enhancement Technology (POTENT), ASC36 oral tablets have demonstrated promising bioavailability results. In trials involving non-human primates, absolute oral bioavailability ranged from 6% to 8%. These results are significant because they enable ASC36 to be more effective even at lower doses, highlighting the potential for improved patient compliance compared to existing obesity treatments.

Encouraging Results in Animal Models

Preliminary results in animal models indicate that ASC36 can lead to substantial weight loss. Specifically, in non-human primate studies, a daily dosage of 10 mg resulted in an average weight reduction of 13.2% over a week. Additionally, these trials showed a considerable decrease in food intake, further amplifying the drug's effectiveness.

In a competitive setting, ASC36 outperformed other treatments such as eloralintide and petrelintide in diet-induced obese rat models, achieving up to 91% greater body weight reduction. Such outcomes present ASC36 as a strong candidate in obesity pharmacotherapy, capable of offering a more significant impact than its contemporaries.

Innovative Technology at Play

The oral tablet's delivery system and formulation were developed using Ascletis' advanced technologies, including Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD). This cutting-edge approach not only aids in the discovery of new drug candidates but also enhances the viability of oral peptide delivery.

The design of ASC36 makes it particularly attractive to both healthcare providers and patients. Due to its long elimination half-life—ranging between 116 to 167 hours—there's potential for once-daily dosing, reducing the pill burden on patients and making adherence to treatment easier.

Looking Ahead: Regulatory Steps

Ascletis aims to submit an Investigational New Drug Application (IND) for ASC36 to the U.S. Food and Drug Administration (FDA) by the second quarter of 2026. This step is crucial in progressing to human clinical trials, signaling a fast-paced approach to bring ASC36 to market. The company is committed to navigating regulatory pathways efficiently to ensure timely availability of ASC36 for patients suffering from obesity.

A Diverse Pipeline for Comprehensive Treatment

In addition to ASC36, Ascletis boasts a robust portfolio of innovative treatments targeting metabolic diseases. Among these are ASC30, a small molecule GLP-1 receptor agonist, and ASC35 and ASC37, which employ various mechanisms to tackle obesity and related metabolic conditions.

Dr. Jinzi Jason Wu, the Founder and CEO of Ascletis, emphasizes the company’s strategic approach in leveraging their technological platforms to cater to diverse patient needs—establishing a competitive edge in obesity treatment that addresses a global health concern.

In conclusion, as Ascletis forges ahead with the clinical development of ASC36, the biotech landscape awaits eagerly. If successful, ASC36 could change the narrative for patients battling obesity, offering hope where traditional treatments may have fallen short. As clinical trials unfold, the medical community and patients alike will be watching closely to see how this promising new treatment develops.