NeuroBo Pharmaceuticals Receives FDA Approval for Obesity Drug Candidate
NeuroBo Pharmaceuticals experienced a significant boost in its stock value following the U.S. Food and Drug Administration's approval of its obesity drug candidate. The company is now poised to move forward with human testing of a product that has demonstrated impressive weight control potential in laboratory rodents.
Advancing to Phase 1 Trial
NeuroBo, headquartered in Cambridge, Massachusetts, is ready to commence a Phase 1 trial for its DA-1726 product in the coming months. This major milestone comes after receiving clearance from the FDA for the commercialization application. The uniqueness of NeuroBo's product candidate lies in the fact that it acts as both a glucagon-like peptide 1 and a "glucagon dual receptor."
Promising Preclinical Studies
Preclinical studies have revealed the exceptional performance of DA-1726 in test animals. When compared to Novo Nordisk's Wegovy, the drug caused a greater reduction in weight, while also demonstrating similar weight control capabilities as Eli Lilly's Mounjaro. Intriguingly, these effects were observed even when the animals consumed more food.
NeuroBo President and CEO, Hyung Heon Kim, commented on these findings, stating, "As previously reported, preclinical evidence has shown that DA-1726 results in persistent weight loss in diet-induced obese mice and rats by reducing food intake while increasing energy expenditure."
Phase I Trial Details
The upcoming Phase 1 trial will consist of a single ascending dose study with approximately 45 patients participating. This trial will provide valuable insights into the safety and efficacy of the drug candidate.
Positive Market Response
Following the FDA approval, NeuroBo's shares surged by an impressive 30% to $4.56 in premarket trading.
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