SOUTH SAN FRANCISCO - Vistagen Therapeutics (VTGN), a clinical-stage neuroscience company with a market capitalization of $81.58 million, has announced encouraging results from a Phase 2A study of its investigational product, PH284 nasal spray, aimed at treating cachexia in cancer patients. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it's currently operating at a loss with an EBITDA of -$45.47 million. Cachexia, a complex syndrome leading to significant weight and muscle loss, is prevalent in patients with advanced cancer and other chronic diseases.
The study, which involved 40 female patients with terminal cancer-induced cachexia, showed that PH284 led to a marked increase in the subjective feeling of hunger compared to a placebo. Notably, on the seventh day of treatment, patients using PH284 reported a 71% improvement in hunger feelings from their baseline measurement, while those on placebo saw less than a 1% increase.
Safety and tolerability of PH284 were also highlighted, showing an adverse event profile comparable to placebo, with no serious adverse events reported. The study's findings suggest that PH284 could potentially improve the quality of life for patients suffering from cachexia by enhancing their appetite, which is crucial for maintaining strength and the effectiveness of treatments like chemotherapy.
PH284 is the fifth pherine product candidate in Vistagen's neuroscience pipeline, each showing positive clinical data and placebo-like tolerability. The company, headquartered in South San Francisco, focuses on developing treatments that utilize the nose-to-brain neurocircuitry without requiring systemic absorption.
The exploratory study conducted in 2005 was sponsored by Pherin Pharmaceuticals, now a subsidiary of Vistagen, and took place at the National Institute of Oncology and National Institute of Nutrition in Mexico City. Following Vistagen's acquisition of Pherin in February 2023, the company gained access to the study's results.
As Vistagen evaluates the potential path forward for PH284, including necessary studies to support a U.S. Investigational New Drug application, the company remains committed to addressing unmet needs in various disorders through its innovative neuroscience pipeline.
This article is based on a press release statement from Vistagen, and it aims to present the study's findings in a factual and unbiased manner.
In other recent news, VistaGen Therapeutics (NASDAQ:VTGN) reported significant developments in its second-quarter fiscal year 2025 earnings update. The company revealed a considerable increase in research and development expenses to $10.2 million, largely due to clinical trials, and a net loss of $13 million. VistaGen's cash reserve stands at $97.6 million.
The company's progress with its Phase 3 clinical trials for fasedienol, a drug candidate for Social Anxiety Disorder, was highlighted by Stifel, a financial services firm. The trials, known as PAL-3 and PAL-4, are enrolling participants at a satisfactory pace, with top-line data expected in the second half of fiscal year 2025.
Stifel reiterated its Buy rating on VistaGen stock, maintaining a steady price target of $12.00. The firm's optimism is partly based on the mixed historical development of fasedienol, with one trial failing and another succeeding.
Furthermore, VistaGen is preparing for Phase 2b trials for another product candidate, itruvone, and a U.S. IND submission for PH80, aimed at treating menopausal hot flashes. The company also plans to submit a new drug application for fasedienol in early 2026. These are some of the recent developments at VistaGen Therapeutics.
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