CAMBRIDGE, Mass. - NeuroBo Pharmaceuticals, Inc. (Nasdaq: NASDAQ:NRBO) has announced the initiation of the multiple ascending dose (MAD) Part 2 of its Phase 1 clinical trial for DA-1726, a novel treatment candidate for obesity. The dosing of the first patient in this stage marks an advancement ahead of the planned schedule, reflecting the company's commitment to fast-tracking the clinical development of the drug.
DA-1726 is an oxyntomodulin (OXM) analog that acts as a dual agonist for the glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR). This dual action is believed to reduce appetite and increase energy expenditure, potentially leading to weight loss. In pre-clinical studies, DA-1726 demonstrated promising results, including superior weight loss compared to existing treatments like semaglutide and tirzepatide, while also preserving lean body mass and showing improved lipid-lowering effects.
The Phase 1 trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of DA-1726 in obese but otherwise healthy subjects. Part 1 of the study, which involves single ascending doses, is expected to enroll about 45 participants. Part 2, now underway, will enroll approximately 36 participants who will receive multiple doses of the drug or a placebo. The primary endpoint of the study is to monitor adverse events and treatment tolerability.
NeuroBo's recent financing, which raised up to $70 million, is set to fund the ongoing clinical development of DA-1726. With this financial backing, the company plans to conduct a multicenter, randomized, double-blind, placebo-controlled Part 3 of the Phase 1 trial after completing Part 2. This next phase will explore the drug's impact on total weight loss and other metabolic and cardiac parameters over 24 weeks.
The company expects to provide top-line data from the single ascending dose Part 1 in the third quarter of this year and from the multiple ascending dose Part 2 in the first quarter of 2025. Interim data from the forthcoming Part 3 is anticipated around mid-2026, with complete top-line results expected in the second half of 2026.
NeuroBo, a biotech firm specializing in cardiometabolic diseases, is also developing DA-1241 for Metabolic Dysfunction-Associated Steatohepatitis (MASH). The information in this article is based on a press release statement from NeuroBo Pharmaceuticals.
In other recent news, NeuroBo Pharmaceuticals has made significant strides in its drug trials. The company announced pre-clinical findings indicating that its drug candidate DA-1241, in combination with semaglutide, shows improved treatment effects for liver fibrosis. The combination therapy yielded better results in reducing hepatic steatosis, inflammation, and fibrosis while improving glucose control in pre-clinical studies. Furthermore, the company has completed enrollment for Part 1 of the Phase 2a clinical trial of DA-1241 in MASH and is anticipating top-line data from the ongoing trial in the fourth quarter of this year.
Additionally, Maxim Group initiated coverage on NeuroBo shares, assigning a Buy rating, citing the development of two promising drugs, DA-1726 and DA-1241. NeuroBo's DA-1241 is currently undergoing a Phase 2a study for MASH, with results expected in the second half of 2024, and DA-1726, aimed at obesity, is in a Phase 1 study, with initial data anticipated in the third quarter of 2024.
In other developments, NeuroBo has completed the first part of its Phase 2a clinical trial for DA-1241, a novel treatment candidate for metabolic dysfunction-associated steatohepatitis (MASH). The primary measure of the drug's success will be the change in alanine transaminase (ALT) levels from the baseline at week 16. The company anticipates reporting full trial data in the second half of this year.
InvestingPro Insights
As NeuroBo Pharmaceuticals (Nasdaq: NRBO) ventures forward with its Phase 1 clinical trial for DA-1726, investors are closely monitoring the company's financial health and market performance. According to InvestingPro, NeuroBo's market capitalization stands at a modest $20.9 million. This valuation reflects the company's current position in the competitive biotech landscape.
With a focus on the company's financial metrics, InvestingPro data indicates that NeuroBo has an adjusted P/E ratio of -1.26, which underscores that the company is not currently profitable. Additionally, the firm's operating income shows a significant deficit of $20.25 million for the last twelve months as of Q1 2024, aligning with the company's stage in the drug development process where upfront costs are high and revenues have not yet materialized.
However, not all indicators are negative. NeuroBo's stock has experienced a significant return over the last week, with a 10.94% price total return, and an even more impressive six-month price total return of 27.93%. This could signal growing investor confidence in the potential of DA-1726 and the company's pipeline.
Investors considering NeuroBo as part of their portfolio may find value in the InvestingPro Tips that highlight the company's liquidity position, with liquid assets exceeding short-term obligations, and the fact that it holds more cash than debt on its balance sheet. These insights suggest a level of financial stability that could support the company's ambitious clinical trial goals. For those looking to delve deeper, InvestingPro offers additional tips to help investors make informed decisions. Currently, there are 10 more InvestingPro Tips available for NeuroBo, which interested parties can explore by visiting https://www.investing.com/pro/NRBO.
For readers looking to access these insights and more, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro. This exclusive offer could provide valuable context for NeuroBo's financial trajectory and market performance as it progresses through the clinical trial phases of DA-1726.
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