Pharma Focus Asia

NeuroBo Pharmaceuticals Receives Approval from Safety Review Committee to Advance Phase 2a Trial for MASH Treatment with DA-1241

Thursday, March 14, 2024

NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO) has recently announced that the Safety Review Committee (SRC) has given its approval for the continuation of the Phase 2a trial of DA-1241. This compound is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist aimed at addressing metabolic dysfunction-associated steatohepatitis (MASH). Following a blinded safety review of the initial six months of study conduct, the SRC recommended that the trial proceed without modification. The Phase 2a trial is focused on assessing both the efficacy and safety of DA-1241 for treating MASH, with the full data expected to be available in the latter half of 2024.

NeuroBo, emphasized the significance of the SRC's recommendation, indicating it as an early affirmation of the safety profile of DA-1241, the company's leading asset for cardiometabolic conditions such as MASH. He highlighted the compound's potential, backed by pre-clinical and clinical evidence demonstrating its effectiveness in reducing hepatic abnormalities and improving glucose control. Moreover, DA-1241 has shown good tolerance in both healthy volunteers and patients with type 2 diabetes mellitus (T2DM).

The Phase 2a trial comprises two parts, each spanning 16 weeks and employing a multicenter, randomized, double-blind, placebo-controlled design. Part 1 aims to evaluate DA-1241's efficacy versus placebo, with an enrollment target of 49 subjects, while Part 2 will explore the compound's efficacy in combination with sitagliptin versus placebo, aiming to enroll around 37 subjects. Primary endpoints for both parts include assessing the change in alanine transaminase (ALT) levels from baseline at Week 16, with secondary endpoints encompassing various lipid and metabolic parameters.

DA-1241, a GPR119 agonist, has shown promise in preclinical studies by promoting the release of beneficial gut peptides that impact liver health, lipid metabolism, weight management, and glucose regulation. Its therapeutic potential has been evidenced in various preclinical models of MASH and T2DM, with favorable safety profiles observed in Phase 1a and 1b trials involving healthy volunteers and individuals with T2DM.

DA-1241 is a novel GPR119 agonist offering flexibility in development as a standalone therapy or in combination for MASH and T2DM. Preclinical investigations have showcased its ability to mitigate hepatic abnormalities and improve metabolic parameters, while early clinical trials have demonstrated its safety and tolerability in relevant patient populations.

 

Source: prnewswire.com

magazine-slider-imageHexagon - Expert Insights WebinarMFA + MMA 20244th Annual Cleaning Validation 20242nd Annual Pharma Impurity Conclave 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Thermo Fisher - Drug Discovery and the impact of mAbsAdvanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference