Latest news with #EoloPharma
Medscape
12 hours ago
- Health
- Medscape
Promising Weight-Loss Compound Targets Energy Expenditure
A new weight-loss compound targeting energy expenditure rather than appetite suppression showed early efficacy in a first-in-human study. The compound, SANA (MVD1; Eolo Pharma), activates creatine-dependent thermogenesis, a novel approach to obesity and metabolic disease compared to appetite suppression, explained Eolo Pharma CEO María Pía Garat. 'To our knowledge, SANA is the only small molecule in clinical development that targets this mechanism, and we expect growing interest in this pathway as our data progresses.' SANA has completed phase 1a/b trials, demonstrating safety, tolerability, and early efficacy over 15 days of treatment, she told Medscape Medical News . 'If upcoming phase 2 trials replicate these results and support a clear benefit-risk profile, we believe SANA could potentially reach the market within the next 4-5 years, subject to regulatory pathways and ongoing trial outcomes.' The study was published online in Nature Metabolism . 'Complementary Therapeutic Approach' SANA, a nitroalkene derivative of salicylate, demonstrated efficacy in preclinical models of diet-induced obesity and significantly reduced liver steatosis and insulin resistance by enhancing mitochondrial respiration and increasing creatine-dependent energy expenditure in adipose tissue. Unlike glucagon-like peptide 1 (GLP-1) receptor agonists that are associated with muscle wasting and loss of lean mass, SANA was shown in preclinical models to significantly preserve and at times increase lean muscle mass while reducing fat mass. Specifically, EchoMRI analysis in diet-induced obese mice showed that SANA-treated animals had a greater percentage of lean body mass than control animals, despite substantial fat loss. Based on the accumulated preclinical evidence indicating that the compound might be a suitable first-in-class drug for treatment of obesity and comorbidities, the researchers embarked on a double-blind, randomized, placebo-controlled phase 1a/b study. The trial included a single ascending dose (200-800 mg) cohort of 17 lean volunteers and a multiple ascending dose (200-400 mg) cohort of 24 individuals with obesity. The primary endpoint was safety and tolerability. Secondary and exploratory endpoints included pharmacokinetics, tolerability, body weight, and metabolic markers. SANA was shown to be safe and well tolerated at all dose levels, with no serious adverse events reported. In the Phase 1b portion, patients receiving the drug experienced a significant reduction in body weight compared to placebo, along with improvements in fasting glucose and insulin resistance as measured by HOMA-IR. The metabolic improvements were observed after 2 weeks of treatment and occurred without any significant changes in diet or activity levels. 'SANA introduces a novel and potentially complementary therapeutic approach to obesity and metabolic disease — one that doesn't rely on appetite suppression but instead taps into a previously underutilized biological mechanism, namely, creatine-driven thermogenesis,' Garat said. 'It may also offer an alternative for patients who cannot tolerate GLP-1 therapies or who experience undesirable side effects. Additionally, its oral or subcutaneous dosing flexibility could support patient adherence in real-world settings.' That said, she added, 'As with any first-in-human compound, long-term safety, especially with chronic use, will need to be carefully monitored.' The study had limitations. Although the human results support the notion that SANA may be effective in humans, the trial was designed to test safety and tolerability. 'The efficacy of SANA in humans needs to be further studied in a phase 2 clinical trial, with longer treatment, increased sample number, and extended measurements to validate its efficacy and mechanism of action,' the authors wrote. 'As such, the efficacy results presented here, although promising, are still preliminary and subject to further validation.' The authors had various forms of funding, as detailed in the paper. Multiple authors declared holding shares in Eolo USA and/or serving as advisors to the company.
Yahoo
16-06-2025
- Health
- Yahoo
Eolo Pharma Publishes First-in-Human Study in Nature Metabolism on Novel Obesity Drug Activating Energy-Burning Pathway
- 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 Media Contact Kimberly Ha KKH Advisors 917-291-5744 while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
WIRED
16-06-2025
- Health
- WIRED
A New Obesity Pill May Burn Fat Without Suppressing Appetite
Jun 16, 2025 5:00 AM An investigational drug developed by Eolo Pharma is showing promise in animal experiments and an early human trial. It could eventually be an alternative or add-on to popular GLP-1 medications. An experimental obesity pill that works in a different way from the wildly popular Ozempic may help people lose weight, according to results from a small, preliminary human trial. Ozempic and other GLP-1 drugs reduce food intake by stimulating a feeling of fullness. They act on the brain to promote satiety and on the gut to slow the movement of food through the stomach, helping people feel full longer. As a result, people on the drugs lose weight because they eat less. But a new drug may be able to burn energy, and thus fat, without reducing appetite. In a Phase I trial described today in the journal Nature Metabolism, the drug led to statistically significant weight loss in participants after two weeks. Dubbed SANA, the drug is derived from salicylate, a compound used to make aspirin. Developed by Eolo Pharma of Montevideo, Uruguay, it activates a pathway called creatine-dependent thermogenesis. Creatine is perhaps best known as a nutritional supplement taken after exercise to help build muscle mass, but the compound also occurs naturally in the human body and is important for energy production. 'It has been known for a long time that creatine has good effects on metabolism,' says Carlos Escande, cofounder and chief scientific officer of Eolo. In the 1970s, researchers found that rats exposed to cold used a lot of creatine. It wasn't until a decade ago that a Harvard team found that creatine is used in fatty adipose tissue during exposure to cold to generate heat. The process of burning energy and generating heat to maintain a stable internal temperature is known as thermogenesis. Creatine-dependent thermogenesis refers to how the breaking down of creatine, particularly in fat cells, contributes to this heat and energy production. 'What we have found is that our compound stimulates this creatine-dependent heat production pathway,' Escande says. In the first part of the trial, Eolo scientists randomly assigned 17 healthy-weight individuals to receive either a placebo or a single pill of SANA at a low, medium, or high dose. At all doses, the drug was safe and well-tolerated with no serious side effects. In the second part of the trial, they tested the drug in 24 participants with obesity for 15 days. Volunteers were randomly sorted into three groups to receive either a placebo or a low, medium, or high dose of SANA twice a day for the length of the study. Each group had six people taking the drug and two on a placebo. During the study period, participants stayed at a clinical facility where they received high-carbohydrate meals. At the end of the two weeks, the participants taking the highest dose of SANA showed weight loss of about 3 percent, which is comparable to the weight loss seen in people taking Ozempic and Wegovy over the same period of treatment. They were also asked to fill out a questionnaire regarding appetite and satiety, and none reported decreased appetite or satiety. While injected GLP-1 drugs are incredibly effective at spurring weight loss, they also come with some downsides. There can be gastrointestinal side effects and loss of muscle mass. The drugs are also expensive, at $1,000 a month or more in the US before insurance. Drug companies are interested in developing anti-obesity pills because of their relatively cheap cost to manufacture compared to injectables, and the fact that some patients would prefer to take a pill. 'There's still an unmet clinical need, and that's where Eolo wants to help,' says María Pía Garat the company's CEO. Eolo didn't exactly set out to make a weight-loss pill. Researchers at the company were originally trying to develop a drug to target inflammation, especially the kind that occurs in obesity and type 2 diabetes. But when they started testing their experimental drug in mice, it not only improved inflammation but also led to a reduction in body weight while they were on a high-fat diet. They have performed experiments out to nine months and found that the mice eventually dropped to their starting weight even while they were still eating the same, high-fat diet. In mice, SANA also preserved lean muscle mass. MRI scans show that mice treated with SANA had a greater percentage of lean body mass compared to controls, despite substantial fat loss. 'We've had stimulants before to try to increase your caloric output,' says Hans Schmidt, chief of bariatric surgery and co-director for the Center for Weight Loss and Metabolic Health at Hackensack University Medical Center, who wasn't involved in the study. One of those was the drug combination fenfluramine-phentermine, known as fen-phen, which was sold in the 1990s for weight loss but was taken off the market for causing heart damage. 'Those work on overall metabolism. They make you jittery, make you energized. This seems to work specifically at a cellular level on your fat cells,' he says. Of course, Eolo's study was very small, and the drug will need to be tested in more people to better understand its effects. The company is planning a Phase II trial later this year that will include around 100 participants with obesity and follow them for 12 weeks. They hope to conduct that trial in the United States. Garat thinks Eolo's drug could eventually be used as a stand-alone approach or in combination with GLP-1 drugs to produce more weight loss. 'Right now we are bringing a backhoe to the construction site when we need many more tools. We need more mechanisms like this that work on pathways other than appetite,' says Angela Fitch, former president of the Obesity Medicine Association and the cofounder and chief medical officer of Knownwell, a primary care company specializing in obesity care. Fitch is not involved with Eolo. Current GLP-1s can achieve up to 20 percent weight loss, and while that may be enough for some patients, others may still need to lose more to get to a healthy weight. 'New medications,' she says, 'present the opportunity to make an even greater impact.'
