Before the GLP-1 agonists became drugs of great success that many people know and use today, Rhythm Pharmaceuticals was investigating molecules that adopt a similar approach but for a different objective. The Biotechnology Drug, Billivree, has FDA approvals for two rare forms of obesity. Preliminary data of a fundamental test in another type of drug placement to the pipe strategy in a continuous rhythm product.
BMIVREE data announced on Monday is a phase 3 test in hypothalamic obesity. Rhythm said his injectable medicine once a day with the main objective of the trial by leading to a significant statistically significant and clinical reduction in the body mass index (BMI) compared to a placebo. The complete results will be presented at a future medical meeting. But according to the preliminary results so far, the Rhythm based in Boston said that it plans to submit requests to the US and European regulators in the third quarter of this year, to see the BMIVREE approach to the hypothalamic obesity.
While GLP-1 drugs are peptides designed to hit receptors for intestinal hormones, the rhythm drug is a peptide designed to join and activate objectives in the brain. Imcivree is specifically designed to direct the melanocortin-4 (MC4R) receiver, a receiver that is mainly in the hypothalamus, a region of the brain that produces hormones that regulate various bodily functions. The MC4R route regulates hunger and energy expenditure.
Cancer patients can develop obesity after surgery or radiation to treat brain tumors. These treatments can damage the hypothalamus, interrupting the MC4R route. When joining and activating the MC4 receiver, the rhythm engineering peptide is intended to restore signaling on this route.
The preliminary results announced Monday from a phase 3 test that registered 120 participants, adults and children. The company said that after a year of treatment, Imcivree led to a 15.5% reduction in the BMI compared to a 3.3% increase in the placebo group. Rhythm added that no new security signs were reported. The side effects informed in the previous drug tests include sexual dysfunction, hypersensitivity and depression and suicidal idea. In the last study, Rhythm said that no serious ads were reported that led to the interruption of the study of the study.
“These data are very clinically significant, and offer hope that a new directed therapy will become aviaxable for patients, both adults and children, who live with the acquired hypothalamic obesity,” Dr. Go. Susan Phillips, pediatric endocrinologist of Rady Children’s Hospital-San Diego and Pediatrics professor at the UC School of Medicine of the UC Medicine San Diego In Rhythm’s announcement of the latest BMIVREE results.
The initial FDA approach of BMIVREE in 2020 covered chronic chronic control, based on three rare protein deficiencies that harm the MC4 receiver route. In 2022, the rhythm drug extended its approval to Bardet-Biedl syndrome, a rare disease that leads to an insatiable hunger. Both indications are genetically driven.
Imcivree approval in hypothalamic obesity would be the first for this medicine in an acquired manner of obesity. It could also potentially become the first treatment approved for this specific type of obesity. Rhythm estimates between 5,000 and 10,000 patients in the US. Uu live with hypothalamic obesity; The company believes that the prevalence of disorder in Europe is similar. That is larger than the populations of patients treated by BMIVREE in their two indications currently approved, giving the rhythm the opportunity to further increase income. By 2024, biotechnology reported $ 130.1 million in products sales, an increase of 68% compared to the previous year.
The rhythm is not the only biotechnology development a hypothalamic medication of obesity. The main candidate of the Aardvark Therapeutics drug is a small molecule designed to block TAS2 receptors in the intestine. This medicine is currently in phase 3 tests in Prader-Willi syndrome, a rare metabolic disorder that leads to insatiable hunger (the first approval of the FDA in Prader-Willi was granted last month to Soleno Therapeutics) last month. Aardvark also plans to develop its drug for hypothalamic obesity. These plans will be supported by the Aardvark OPI, which raised $ 94 million in February.
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