A drug that mimics the effects of physical activity on the human body has been well tolerated, with no significant side effects, and has shown signs of efficacy in the 88 volunteers who tested it in its first clinical trial, according to the American biotechnology company Enveda in a statement.
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The drug is inspired by the molecule Lac-Phe, discovered in 2022, which the body produces during physical activity and which regulates metabolism. One of its most notable effects is that it reduces appetite. Using an AI model, Enveda scientists have created a molecule similar to Lac-Phe, currently called ENV-308, which has the virtue of remaining longer in the body and is taken as a pill once a day.
It is expected to be a treatment for obesity, but has not yet been proven to reduce weight
The company hopes the drug will become a new option for the treatment of overweight and obesity, although so far ENV-308 has not yet demonstrated efficacy in reducing weight.
“Many of the benefits of exercise are due to chemical messengers released in the body,” says Viswa Colluru, Ph.D., founder and CEO of Enveda, in the statement. “Until Lac-Phe was characterized, almost none of this chemistry was within our reach to guide the development of viable drugs. ENV-308 is our attempt to incorporate exercise chemistry into a daily pill.”
Early data indicate that ENV-308 may have fewer adverse effects than therapies based on the GLP-1 hormone such as semaglutide (marketed as Ozempic or Wegovy) or tirzepatide (marketed as Mounjaro). Some people starting treatment with these therapies experience gastrointestinal discomfort such as nausea, vomiting, or diarrhea during the first days or weeks of treatment.
The 88 participants in the ENV-308 clinical trial were “healthy volunteers with overweight or obesity,” a spokesperson for Enveda told La Vanguardia. They took the pill over four weeks and were monitored from the start of treatment until one week after finishing it.
As is usual in a phase 1 clinical trial, the main goal was to assess the safety of different doses of the drug. “Participants tolerated ENV-308 well at all doses, with an exceptional gastrointestinal safety profile,” Enveda highlights in its statement. “No serious adverse effects, treatment discontinuations, or dose interruptions were recorded in the study.”
These results support the initiation of a phase 2 clinical trial, where the main objective will be to explore the treatment’s efficacy. Changes in weight, body composition, and metabolic health markers will be analyzed. Enveda plans to start the phase 2 trial this fall in people who have previously taken semaglutide or tirzepatide and have discontinued treatment, the company spokesperson reports.
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The only sign of efficacy reported so far is the reduction of leptin, a hormone secreted by body fat. In healthy people, a high leptin level signals the brain that the body has sufficient energy reserves, which suppresses appetite. But in obese people, whose leptin levels are always high, the brain becomes insensitive to the hormone, causing constant hunger.
The drug ENV-308 has reduced leptin levels in both animals and people. The greatest reductions were recorded in volunteers who had the highest levels at the start of the clinical trial, which is “potentially consistent with a better response and sensitivity to leptin” and therefore would suppress appetite, Enveda notes in the statement, which does not provide quantitative data.
The company has not reported differences based on sex, age groups, or different body mass indices. “We will provide these data at a future date,” the spokesperson clarified, but “we cannot yet announce at which conference, scientific journal, or date they will be presented.”
The Lac-Phe molecule, on which the drug ENV-308 is based, has been shown to reduce obesity in mice, according to data presented when it was discovered in 2022. Specifically, it reduces body fat, improves glucose control, and reduces food intake.
It is a metabolite synthesized from lactate (which the body produces during exercise by breaking down glucose for energy) and phenylalanine (one of the essential amino acids used to build proteins).
Its production increases with all types of physical activity and is greater the more intense the exercise. It is highest during a sprint, intermediate in strength exercises, and lower in moderate-intensity aerobic exercises.
In people who exercise for 30 minutes, Lac-Phe levels begin to rise from the start of the activity and continue to increase until half an hour after finishing. Then it decreases again, but three hours later it remains above the initial level.
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