CAMBRIDGE, Mass. - NeuroBo Pharmaceuticals, Inc. (NASDAQ: NASDAQ:NRBO), a biotech firm specializing in cardiometabolic diseases, announced today that its Phase 2a clinical trial of DA-1241 will continue without changes following a favorable safety review. The trial evaluates DA-1241, a novel treatment for metabolic dysfunction-associated steatohepatitis (MASH), a condition lacking approved treatments.
The Safety Review Committee (SRC) recommended the continuation after reviewing the first six months of the trial, finding no significant adverse safety trends. DA-1241, a G-Protein-Coupled Receptor 119 (GPR119) agonist, has shown promise in reducing liver issues and improving glucose control in preclinical and early clinical trials. The full data readout is expected in the latter half of 2024.
The ongoing double-blind, placebo-controlled study is split into two parts. Part 1 tests DA-1241 against a placebo, aiming to enroll up to 55 subjects, while Part 2 combines DA-1241 with sitagliptin, planning for approximately 37 participants. The primary measure is the change in alanine transaminase (ALT) levels, with secondary endpoints assessing cholesterol, triglycerides, and other metabolic factors.
Hyung Heon Kim, President and CEO of NeuroBo, expressed confidence in DA-1241's safety and potential efficacy for MASH treatment. The company expects another SRC analysis after 50% of the trial's participants have been randomized and dosed.
NeuroBo is also developing treatments for Type 2 Diabetes Mellitus (T2DM) and obesity, including DA-1726, an oxyntomodulin analogue with dual agonist properties.
This announcement is based on a press release statement.
InvestingPro Insights
As NeuroBo Pharmaceuticals, Inc. (NASDAQ: NRBO) continues its Phase 2a clinical trial for DA-1241, investors are watching the company's financial health and stock performance closely. With a market capitalization of 21.47 million USD, NeuroBo is a smaller player in the biotech field, which can often lead to higher volatility in stock prices. Indeed, NeuroBo's stock has experienced significant fluctuations recently, with a notable 13.19% decrease in the last week alone. However, looking at a longer timeframe, the stock has shown resilience with a 34.68% return over the last six months.
Despite the recent downturn, NeuroBo's balance sheet holds more cash than debt, which is a positive sign for the company's financial stability. This is a critical factor for investors, as it suggests that NeuroBo may have a safety net to continue funding its operations and research, despite the company quickly burning through cash. Moreover, NeuroBo's liquid assets exceed its short-term obligations, providing further assurances about the company's ability to meet its immediate financial commitments.
Investors should note that NeuroBo has not been profitable over the last twelve months and has weak gross profit margins, which could be a concern for long-term profitability. Also, the stock does not pay a dividend, indicating that any potential returns would solely come from stock price appreciation, which has been poor over the last decade.
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