CAMBRIDGE, Mass. - NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO) shared positive initial data from the first part of its Phase 1 clinical trial for the obesity drug DA-1726. The single ascending dose (SAD) study of DA-1726, a novel dual oxyntomodulin analog agonist, showed favorable safety, tolerability, and pharmacokinetics among 45 obese but otherwise healthy participants.
The trial, which included a double-blind, placebo-controlled design, reported no serious adverse events. The treatment group experienced adverse events in 5 subjects, compared to 3 in the placebo group. The company also observed a dose-linear pharmacokinetic profile across the investigated dose range.
NeuroBo's President and CEO, Hyung Heon Kim, expressed optimism about the results, which supported the progression to the multiple ascending dose (MAD) part of the study. The MAD Part 2, expected to enroll around 36 participants, will further investigate the safety, tolerability, and pharmacokinetics of DA-1726.
The first patient in the MAD study was dosed ahead of schedule in late June. Top-line data from this study is anticipated in the first quarter of 2025, which will provide insights into the drug's clinical efficacy. A third part of the trial is planned to evaluate early proof of concept.
DA-1726 acts on glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR), which is associated with reduced appetite and increased energy expenditure. This mechanism could potentially lead to more effective weight loss compared to current treatments.
The Phase 1 trial's primary endpoint is to assess the safety and tolerability of DA-1726. Secondary endpoints include pharmacokinetic assessment, while exploratory endpoints will evaluate the drug's impact on metabolic and cardiac parameters, lipid levels, body weight, waist circumference, and body mass index (BMI).
This announcement is based on a press release statement from NeuroBo Pharmaceuticals.
In other recent news, NeuroBo Pharmaceuticals has received shareholder approval for a substantial issuance of shares, potentially increasing the company's common stock by more than 20%. This move could provide NeuroBo with additional capital for its research and development endeavors. The company has also made significant strides in clinical trials, initiating the multiple ascending dose Part 2 of its Phase 1 clinical trial for DA-1726, an obesity treatment candidate, ahead of schedule.
In partnership with Dong-A ST Co. Ltd. and ImmunoForge, NeuroBo is developing a once-monthly obesity treatment using a novel technology aimed at extending the drug's half-life. The collaboration seeks to transform DA-1726 into a long-acting form, potentially addressing the challenges of frequent dosing. This technology has shown promise in other clinical trials conducted by ImmunoForge.
NeuroBo has also licensed NB-01, a drug candidate for painful diabetic neuropathy, to MThera Pharma. MThera Pharma has the rights to conduct further research and potentially initiate a Phase 3 clinical trial. This licensing aligns with NeuroBo's strategy to out-license legacy assets and focus on the development of other clinical programs.
In financial activities, NeuroBo has secured $20 million through a private placement and registered direct offering, with potential for an additional $50 million upon the full exercise of associated warrants. The Maxim Group has initiated coverage on NeuroBo shares, assigning a Buy rating, citing the development of both DA-1726 and DA-1241. These recent developments highlight NeuroBo's commitment to advancing its clinical trials and reflect the potential of its drug candidates.
InvestingPro Insights
As NeuroBo Pharmaceuticals (NASDAQ:NRBO) advances its obesity drug DA-1726 through clinical trials, investors should consider some key financial metrics and insights from InvestingPro.
According to InvestingPro data, NeuroBo has a market capitalization of $28.18 million, reflecting its current status as a small-cap biopharmaceutical company. The company's stock price closed at $3.32 in the most recent trading session, which is about 49.19% of its 52-week high. This suggests there might be room for growth if the clinical trials continue to yield positive results.
InvestingPro Tips highlight that NeuroBo holds more cash than debt on its balance sheet, which is crucial for a company in the resource-intensive drug development phase. This financial cushion could provide the necessary runway to complete the ongoing clinical trials and potentially advance DA-1726 to later stages of development.
However, investors should be aware that NeuroBo is quickly burning through cash, as indicated by another InvestingPro Tip. This is not uncommon for biotech companies in the research and development phase, but it underscores the importance of successful trial outcomes and potential future fundraising needs.
The company's operating income for the last twelve months stands at -$26.52 million, reflecting the substantial costs associated with drug development. This aligns with the InvestingPro Tip noting that NeuroBo is not profitable over the last twelve months, which is typical for early-stage biopharmaceutical companies.
For those interested in a deeper dive into NeuroBo's financial health and market position, InvestingPro offers 9 additional tips, providing a more comprehensive analysis to inform investment decisions in this promising yet volatile sector.
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