Vistagen has reported positive outcomes from the exploratory Phase IIA trial of an investigational pherine nasal spray, PH284, for the treatment of cancer cachexia.
The ‘previously unreported’ double-blind, placebo-controlled Phase IIA study assessed the efficacy, safety, and tolerability of the nasal spray in 40 female subjects with cachexia due to terminal cancer. The nasal spray was administered four times a day before meals.
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The trial demonstrated a significant increase in the mean subjective feeling of hunger among subjects using PH284, compared to those receiving a placebo, without any serious adverse events.
On day seven, patients treated with the spray reported an improvement of 71% in the subjective feeling of hunger (SFH), compared to a less than 1% increase in the placebo group.
Despite no unusual changes in body weight, PH284 subjects experienced a slight weight gain, compared to a small weight loss seen in the placebo group.
Vistagen CEO and president Shawn Singh said: “We are highly encouraged by the potential of PH284 to improve the quality of life for those challenged by the debilitating impacts of cancer cachexia.
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By GlobalData“PH284 is our fifth novel investigational pherine, each supported by positive Phase II or later clinical data and placebo-like tolerability, underscoring the breadth, diversity, and potential of our neuroscience pipeline to address multiple significant unmet needs.”
Sponsored by Vistagen’s wholly owned subsidiary, Pherin Pharmaceuticals, the unreported Phase IIA trial was conducted in 2005 at the National Institute of Oncology (INCAN) and the National Institute of Nutrition (INNSZ) in Mexico.
Vistagen acquired the study outcomes following its acquisition of Pherin in February 2023.
PH284’s mechanism of action is claimed to be distinct from existing treatments for appetite loss associated with chronic conditions, such as cancer or heart disease. The nasal spray is part of the company’s neuroscience pipeline and is the fifth pherine product candidate to show a ‘positive efficacy signal’.
Referred to as wasting syndrome, cachexia is stated to be a complex metabolic syndrome associated with chronic diseases, leading to muscle and weight loss.
In April last year, the company enrolled the first subject in the Phase III PALISADE-3 trial of fasedienol (PH94B) for treating social anxiety disorder (SAD).
