NeuroBo Pharmaceuticals has received approval from the Safety Review Committee (SRC) to proceed with its Phase IIa clinical trial of DA-1241 for metabolic dysfunction-associated steatohepatitis (MASH), without any modifications.
This decision comes after a thorough review of the initial six months of the trial, which remains blinded for safety assessment.
The ongoing Phase IIa trial aims to determine the efficacy and safety of DA-1241 in treating MASH.
The trial consists of two parts, each of which is a 16-week, multicentre, randomised, double-blind, placebo-controlled study.
NeuroBo expects to release comprehensive data from the trial in the second half of this year.
Part I of the trial is currently assessing the efficacy of DA-1241 compared to a placebo.
It is expected to enrol 49 participants, with a maximum of 55 to allow for any early dropouts. Participants are being randomised into three groups in a 1:2:1 ratio to receive either 50mg, 100mg of DA-1241, or a placebo.
Part II will investigate the efficacy of DA-1241, along with sitagliptin, versus a placebo.
Approximately 37 subjects are anticipated to participate, with randomisation in a 2:1 ratio between the combined treatment group and the placebo group.
The change in alanine transaminase (ALT) levels from the baseline at week 16 is the primary endpoint for both parts of the trial.
Secondary outcomes include the rate of ALT normalisation and changes in cholesterol levels, triglycerides, and free fatty acids, among other metrics.
The proportion of participants having normalised ALT levels, absolute change in total cholesterol, low and high-density lipoprotein cholesterol, triglycerides, and free fatty acids from baseline, among others will be the secondary efficacy endpoints.
NeuroBo Pharmaceuticals president and CEO Hyung Heon Kim said: “The SRC's recommendation that the trial continue without modification based on no findings of significant adverse safety trends during the first six months of study conduct is an early indication of the safety of our most advanced cardiometabolic asset, DA-1241, for patients with presumed MASH, a disease with no currently approved treatment options.
“Based on the pre-clinical and clinical evidence generated to date, DA-1241 has demonstrated reduced hepatic steatosis, hepatic inflammation and liver fibrosis while also improving glucose control, and was shown to be well tolerated in both healthy volunteers and in patients with type 2 diabetes mellitus (T2DM).”
Recently, the US Food and Drug Administration (FDA) approved NeuroBo’s investigational new drug (IND) application for DA-1726 to commence a Phase I clinical trial to treat obesity.
