New data show clinical safety and early efficacy of SANA, a first-in-class compound that targets creatine-dependent thermogenesis
MONTEVIDEO, Uruguay, June 16, 2025 (GLOBE NEWSWIRE) -- Eolo Pharma , a clinical-stage biotechnology company developing therapies for obesity and metabolic disease, today announced the publication of its first-in-human study in Nature Metabolism , highlighting the safety, tolerability, and early efficacy of its lead compound, SANA (salicylic acid nitroalkene), also known as MVD1.
The peer-reviewed article, titled “ A nitroalkene derivative of salicylate, SANA, induces creatine-dependent thermogenesis and promotes weight loss ,” establishes SANA as the first therapeutic candidate to safely and pharmacologically activate creatine-dependent thermogenesis in humans, using a unique mechanism of action that increases energy expenditure rather than suppressing appetite. This novel approach offers a potential combination approach or monotherapy alternative to currently marketed GLP-1 receptor agonists, which are associated with muscle loss and gastrointestinal side effects.
In a double-blind, randomized, placebo-controlled Phase 1a/b study, healthy lean individuals and participants with obesity received oral SANA for 15 days. The trial included a single ascending dose (SAD) cohort of 17 healthy volunteers and a multiple ascending dose (MAD) cohort of 24 individuals with obesity. The trial demonstrated that SANA was safe and well tolerated at all dose levels, with no serious adverse events reported. In the Phase 1b portion, patients receiving SANA experienced a statistically significant reduction in body weight compared to placebo, along with improvements in fasting glucose and insulin resistance as measured by HOMA-IR.
These metabolic improvements were observed after just two weeks of treatment and occurred without any significant changes in diet or activity levels.
In addition, unlike currently marketed GLP-1 receptor agonists which are associated with muscle wasting and loss of lean mass, SANA was shown in preclinical models to significantly preserve and even increase lean muscle mass while reducing fat mass. EchoMRI analysis in diet-induced obese mice revealed that SANA-treated animals had a greater percentage of lean body mass compared to controls, despite substantial fat loss. These effects are attributed to SANA's unique mechanism of action of enhancing creatine-dependent thermogenesis and mitochondrial respiration in adipose tissue without reducing food intake.
“This is the first time a drug has been shown to pharmacologically activate creatine-based thermogenesis, which could lead to a novel therapeutic approach for obesity in humans,” said Carlos Escande, Ph.D., Chief Scientific Officer and Co-Founder, Eolo Pharma and senior author of the study. “It opens up an entirely new therapeutic pathway for obesity and metabolic disorders, complementary to GLP-1 therapies but targeting the body's ability to burn energy, and not just suppressing appetite.”
“SANA is the result of over a decade of rigorous science in Latin America that has the potential to reshape how we treat obesity and insulin resistance,” said María Pía Garat, CEO and Co-Founder, Eolo Pharma. “We're proud to be the first biotech in South America to take a first-in-class small molecule from discovery into the clinic. We're looking forward to advancing this novel, first-in-class therapy in clinical trials for patients who need safer, more effective options to treat obesity.”
Eolo Pharma plans to initiate Phase 2 clinical trials in 2025 to evaluate SANA's long-term safety and efficacy as both a standalone and combination therapy for metabolic disease.
About SANA
SANA (salicylic acid nitroalkene) is a first-in-class, orally administered small molecule that increases energy expenditure by activating creatine-dependent thermogenesis, a natural heat-generating mechanism in cells. In both animal and human studies, SANA has demonstrated the ability to reduce weight, improve glucose control, and reverse insulin resistance, offering a novel mechanism for treating obesity and related metabolic disorders. The compound is being developed for obesity, type 2 diabetes, and other cardiometabolic diseases.
About Eolo Pharma
Eolo Pharma is a clinical-stage biotechnology company advancing first-in-class small molecule therapies for obesity and metabolic disease. The company's research focuses on targeting underexplored metabolic pathways to increase energy expenditure and improve insulin sensitivity. Its lead candidate, SANA, is the first compound shown to pharmacologically activate creatine-dependent thermogenesis in humans. The company is based in Montevideo, Uruguay. For more information visit www.eolo-pharma.com
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