CAMBRIDGE, Mass. - NeuroBo Pharmaceuticals, Inc. (NASDAQ: NASDAQ:NRBO) has announced the completion of the first part of its Phase 2a clinical trial for DA-1241, a novel treatment candidate for metabolic dysfunction-associated steatohepatitis (MASH). The trial has now fully enrolled approximately 49 patients with presumed MASH, who have been randomized into three groups to receive either two different dosages of DA-1241 or a placebo.
The study, a 16-week, multicenter, randomized, double-blind, placebo-controlled trial, aims to assess the efficacy and safety of DA-1241. The primary measure of the drug's success will be the change in alanine transaminase (ALT) levels from the baseline at week 16, with secondary endpoints including normalization of ALT and changes in cholesterol levels, triglycerides, and free fatty acids, among others.
Hyung Heon Kim, President and CEO of NeuroBo, expressed optimism about the potential of DA-1241, citing its well-tolerated use in healthy volunteers and patients with type 2 diabetes mellitus (T2DM). He also noted that Part 2 of the Phase 2a trial, which will test DA-1241 in combination with sitagliptin, a DPP-4 inhibitor, is still enrolling patients. This combination is expected to show synergistic effects compared to DA-1241 alone.
DA-1241, a G-Protein-Coupled Receptor 119 (GPR119) agonist, has shown promise in preclinical studies for its effects on glucose and lipid metabolism, as well as liver inflammation. The company anticipates reporting full trial data in the second half of this year.
NeuroBo focuses on developing treatments for cardiometabolic diseases and is also working on DA-1726 for obesity treatment. The information in this article is based on a press release statement. For further details on the clinical trial, interested parties can refer to the listing on www.clinicaltrials.gov under the identifier NCT06054815.
InvestingPro Insights
As NeuroBo Pharmaceuticals, Inc. (NASDAQ: NRBO) progresses with its Phase 2a clinical trial for DA-1241, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, NeuroBo's market capitalization stands at a modest 20.07 million USD. The company's Price to Earnings (P/E) ratio is currently negative, at -1.66, reflecting its lack of profitability over the last twelve months. Furthermore, the Price/Book ratio as of the last twelve months ending Q4 2023 is 1.2, which can offer insights into how the market values the company's net assets.
An InvestingPro Tip highlights that NeuroBo holds more cash than debt on its balance sheet, which could provide a cushion as the company continues to burn through cash. The tip also notes that NeuroBo's liquid assets exceed its short-term obligations, suggesting a degree of financial stability in meeting its immediate liabilities. However, the company's stock price has seen a significant decline over the past month, with a 34.46% drop, which could be a point of concern for potential investors. Yet, it's worth noting that the stock has experienced a 10.64% total return year-to-date, indicating some recovery in the short term.
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