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BURLINGTON, Mass. - Neuphoria Therapeutics Inc. (NASDAQ:NEUP), whose stock has surged 279% year-to-date and is trading near its 52-week high of $13.34, has completed target enrollment of 332 participants in its AFFIRM-1 Phase 3 trial evaluating BNC-210 for social anxiety disorder (SAD), the company announced Thursday. According to InvestingPro analysis, the company maintains an "EXCELLENT" financial health score of 3.89.
The clinical-stage biotechnology company, with a market capitalization of $22.47 million, is developing BNC-210 as a first-in-class, acute, as-needed treatment for SAD. The drug has received FDA Fast Track designation for acute treatment of SAD and other anxiety-related disorders. The company’s strong financial position is evidenced by its impressive current ratio of 11.01, indicating robust liquidity to fund its development programs.
"Achieving this milestone puts us on a clear path toward our first Phase 3 data for BNC-210, now expected early in the fourth quarter," said Spyros Papapetropoulos, President and CEO of Neuphoria.
The AFFIRM-1 trial is a multi-center, double-blind study comparing a single 225 mg dose of BNC-210 against placebo. Participants undergo a public speaking challenge approximately one hour after dosing, with the primary endpoint measuring changes in distress levels during the performance phase.
BNC-210 is an oral, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor. According to the press release, the drug has demonstrated rapid-onset anti-anxiety effects in previous clinical trials without sedation, cognitive impairments, or addiction potential.
Social anxiety disorder affects an estimated 31 million Americans at some point in their lives, making it one of the most common mental disorders in the United States. The condition can significantly interfere with daily activities and relationships.
Neuphoria is also developing BNC-210 for post-traumatic stress disorder and has partnerships with Merck & Co. for drugs targeting cognitive deficits in Alzheimer’s disease and other central nervous system conditions.
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