Enveda Reports Initial Phase I Data for ENV-308, a Tablet Designed to Mimic Lac-Phe, Which Rises After Exercise

Enveda Reports Initial Phase I Data for ENV-308, a Tablet Designed to Mimic Lac-Phe, Which Rises After Exercise

As of the August 18 release, the study had enrolled 88 healthy adults. The next phase will assess whether the candidate can help maintain weight loss after patients stop taking drugs that act on the GLP-1 hormone receptor and reduce appetite.

The development of ENV-308 began with Lac-Phe, a compound whose level rises after exercise. In a 2022 Nature study, researchers observed this increase in mice, racehorses, and humans. In mice with obesity, pharmacologically increasing Lac-Phe reduced food intake, fat mass, and body weight. In animals with impaired Lac-Phe synthesis, exercise was less effective at limiting weight gain. These findings linked one signal produced by exercise to the regulation of feeding behavior.

Enveda reports that Lac-Phe is rapidly cleared from the body, so the company is developing ENV-308 as a once-daily tablet intended to reproduce its effects. According to Enveda, the company identified the candidate using PRISM, an AI model trained on 1,2 billion small-molecule mass spectra. A mass spectrum is a chemical fingerprint of a molecule. The instrument breaks the molecule apart and measures the masses of the resulting fragments. The model uses this pattern to estimate the compound's structure and properties.

Phase I studies assess safety, tolerability, and how a drug behaves in the body. According to Enveda, the study had no serious adverse events, participant withdrawals, or dosing interruptions. The company also measured leptin, a hormone produced by adipose tissue that informs the brain about the body's energy stores, and reported a decrease in blood leptin levels.

Phase II will enroll people who have stopped or plan to stop GLP-1 therapy. Enveda plans to assess whether ENV-308 can maintain weight loss and improvements in other metabolic measures.