PH284 Nasal Spray May Improve Feelings of Hunger in Cancer Cachexia

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Treatment with the investigational pherine nasal spray, PH284, demonstrated safe results and increased feelings of hunger in patients with cancer cachexia, according to a press release from Vistagen, the drug’s manufacturer.

According to the release, cachexia, also known as wasting syndrome, is a complex metabolic syndrome that causes a gradual loss of muscle and body weight. Cancer cachexia is defined by the news release as a loss of 5% or more of body weight over the preceding six months, accompanied by other symptoms, including fatigue and reduced strength.

“Loss of appetite from cancer and other illnesses not only negatively impacts overall health and quality of life, but can also reduce the effectiveness of critical therapies, such as chemotherapy in cancer patients,” said Shawn Singh, President and Chief Executive Officer of Vistagen. “PH284 is our fifth novel investigational pherine, each supported by positive phase 2 or later clinical data and placebo-like tolerability, underscoring the breadth, diversity and potential of our neuroscience pipeline to address multiple significant unmet needs.”

Patients treated with PH284 experienced an increased effect on mean subjective feeling of hunger (SFH) scores, as compared with patients treated with a placebo. SFH scores increased from breakfast to lunch and then lunch to dinner throughout the entire treatment period. Specifically, on the seventh day of treatment, before dinner, patients treated with PH284 reported a 71% improvement in SFH compared with their baseline levels, while patients treated with placebo led to a significantly lower improvement of less than 1%.

Regarding safety, no unusual changes in body weight were observed in either the PH284 or placebo groups; however, on average, there was a small gain in body weight for patients receiving PH284 versus a small loss in body weight for patients receiving the placebo. PH284 demonstrated no serious side effects, and side effects reported for the PH284 group were comparable to those shown in the placebo-treated group. All side effects were attributed to the patients’ cancer and were not considered to be related to the administration of PH284 or placebo.

A previously unreported, double-blind, placebo-controlled, exploratory phase 2A study evaluated the efficacy, safety and tolerability of intranasal, through the nose, PH284 nasal spray in 40 female patients with cachexia (induced by chronic loss of appetite) due to terminal cancer.

Patients in the nasal spray group received 0.4 micrograms per 50 microliters through the nose. Treatment consisted of one spray in each nostril (total daily dose of 3.2 micrograms), four times a day, each before daily meals (breakfast, mid-morning snack, lunch and dinner). Patients in the placebo group received the placebo from day 1 to 4, and 30 minutes prior to each meal. SFH responses were recorded 10 minutes before each meal.

PH284 is an experimental nasal spray being studied as a potential treatment for appetite loss related to serious illnesses like cancer or heart disease, according to the release. It works differently than current treatments by targeting specific brain pathways involved in appetite control. PH284 has shown a good safety record in past trials. Vistagen is now analyzing the potential path forward for PH284.

“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,” Singh concluded in the release.

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