NeuroBo Pharmaceuticals Announces Submission of IND Application to the FDA for a Phase 2a Clinical Trial of DA-1241 for the Treatment of NASH

NeuroBo Pharmaceuticals Announces Submission of IND Application to the FDA for a Phase 2a Clinical Trial of DA-1241 for the Treatment of NASH

NeuroBo Pharmaceuticals (NASDAQ: NRBO ), Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company primarily focused on cardiometabolic diseases, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The IND application supports a Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in development for the treatment of nonalcoholic steatohepatitis (NASH).

"Filing of the IND for DA-1241 marks the first significant milestone for NeuroBo since acquiring the rights to this very promising cardiometabolic asset which is targeted to address the underserved NASH market," stated Joe Hooker, Interim President and Chief Executive Officer of NeuroBo. "I would like to thank our entire team, who worked tirelessly to move this asset into the IND process, ahead of schedule, bringing us one step closer in the development of this potential therapy, for which there are currently no approved treatments.

"Based on preclinical evidence generated, to date, administration of DA-1241 has shown reduced hepatic steatosis, inflammation, and fibrosis, as well as improved lipid metabolism and glucose control regardless of body weight reduction. Additionally, in Phase 1a/1b clinical studies, DA-1241 was well tolerated in both healthy volunteers and in patients with type 2 diabetes (T2D). It is our belief, based on this evidence, that the mechanism of DA-1241 will translate into a safe and effective treatment for NASH. We look forward to initiating the clinical development for DA-1241 and, if regulatory review of our IND is completed, key upcoming milestones for this program include enrollment of our first patient, expected in the third quarter of this year, with data targeted for the second half of 2024. We also intend to advance our second cardiometabolic asset, DA-1726, through the IND process this year, with the goal of initiating a Phase 1a safety study in the first half of next year, for which data would also be expected in the second half of the year. We are excited about the new direction of the company as well as the potential of these assets and look forward to executing on these new pipeline programs."

The Phase 2a trial of DA-1241 is expected to be a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel arm study to evaluate the efficacy and safety of DA-1241 in subjects with presumed NASH. The trial is expected to enroll a total of 87 subjects, with a planned maximum of 98 subjects to account for early discontinuations, who will be randomized into 4 treatment groups and will be dosed with: DA-1241 50 mg, DA-1241 100 mg, DA-1241 100 mg/Sitagliptin 100 mg, or Placebo in a 1:2:2:2 ratio. Randomization will be stratified by Type 2 Diabetes Mellitus (T2DM) status at baseline. The primary endpoint is the change from baseline in alanine transaminase (ALT) levels at Week 16/Day 112. Secondary efficacy endpoints include the proportion of subjects with normalization of ALT, relative percent change in liver fat fraction from baseline, absolute change in liver fat from baseline, and proportion of subjects with a 30% or more reduction in liver fat from baseline, among others. Safety will be evaluated by monitoring adverse events (AEs) including determination of serious adverse events (SAEs) and AEs leading to discontinuation and laboratory abnormalities as characterized by type, frequency, timing, severity (mild, moderate, severe), seriousness and relationship to DA-1241, vital signs measurements, clinical laboratory tests and electrocardiogram (ECG) assessments.

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