Hong Kong-based Ascletis Pharma’s once daily oral small molecule glucagon-like peptide 1 receptor agonist (GLP-1RA), has demonstrated a 6.3% cut in body weight after 28 days in a Phase Ib trial.
Interim results from the double-blind, placebo-controlled, multiple ascending dose (MAD) study (NCT06680440), similarly saw a 4.3% mean body weight reduction from baseline after 28 days in the second cohort who received lower doses of the oral GLP-1RA, dubbed ASC30.
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Following the announcement the company’s stock value began to steadily rise from a close of $4.54HKD on 18 February to a high of $4.96HKD today (19 February).
Jinzi Jason Wu, founder of Ascletis, said: “We are excited that these interim results from our Phase Ib MAD study demonstrated potential best-in-class characteristics to treat patients with obesity.
“As a small molecule, ASC30 has the potential to offer both once-daily oral and once-monthly subcutaneous injection dosing options for patients, if approved.”
The trial consists of three separate cohorts, with the first receiving four dose levels, from 2mg to 5mg, 10mg, and 20mg, or placebo. The second received doses of 2mg, 10mg, 20mg, and 40mg. After 28 days of treatment, mean body weight reductions from baselines were 6.3% with no serious adverse events (AEs) reported. There were however some gastrointestinal-related AEs recorded in the first cohort, but there are mild or moderate and consisted of vomiting.
The company has not yet released data on the third cohort which is being dosed at levels up to 60mg, but this is expected later this year.
In January of this year, Ascletis announced positive topline results from its US single ascending dose (SAD) study (NCT06680440). The company is also working on a monthly subcutaneous version of the GLP-1RA which is currently in Phase I trials.
In the field of subcutaneous GLP-1RAs, the company is entering into a space dominated by Novo Nordisk’s Wegovy (semaglutide) and Eli Lilly’s Zepbound (tirzepatide), both of which by 2030 are expected to bring in sales of $19.56bn and $27.58bn respectively. GlobalData forecasts the global weight loss market is set to reach $206.5bn by the end of 2031.
Also in the oral GLP-1RA ring is pharma giant Pfizer with its candidate danuglipron. In a Phase IIb trial (NCT04707313), the drug, which was investigated as a twice-daily dosing schedule, led to a weight loss of between 6.9% and 11.7% after 32 weeks, and between 4.8% and 9.4% at 26 weeks. The trial evaluated danuglipron in adults with obesity and without type 2 diabetes. Pfizer stated it would not be continuing its investigation into a twice-daily dosing schedule but will instead focus on the once-daily regimen.
