Rhythm's drug shows promise in study to treat brain damage-related obesity
The drug, bivamelagon, was tested in a mid-stage trial to treat patients with acquired hypothalamic obesity, caused by damage to the brain's hypothalamus.
Rhythm estimates there are up to 20,000 people with the condition in the U.S. and European Union.
Eight patients who received the maximum 600 mg dose in the trial showed a reduction of 9.3% in their body mass index, a common measure of body fat based on a person's height and weight.
Patients who received a 400 mg dose showed a reduction of 7.7%, and those on the lowest 200 mg dose, a reduction of 2.7%.
The trial included 28 patients aged 12 years or older.
Rhythm said bivamelagon showed BMI reductions consistent with its lead drug, setmelanotide, sold as Imcivree in the U.S. to treat a genetic form of obesity.
Setmelanotide is also being tested to treat acquired hypothalamic obesity. Both drugs target mechanisms that regulate appetite and energy expenditure.
Wall Street analysts said data shows bivamelagon has a lower tendency for skin darkening than Imcivree and could provide a more convenient oral option for patients.
Bivamelagon could bring in over $1 billion sales by 2032, when Imcivree is expected to lose its patent, Citizens Bank analyst Jonathan Wolleben said.
In the bivamelagon study, four patients reported mild, localized skin darkening. Other side effects were mild diarrhea and nausea, and one patient discontinued treatment after suffering from rectal bleeding.
Rhythm licensed bivamelagon from LG Chem last year.
It plans to discuss with U.S. and European Union regulators the design of its late-stage study and to refine the formulation to improve tolerability.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Daily Mail
24 minutes ago
- Daily Mail
Officials warn the next opioid epidemic could come from substance sold at vape shops for less $10
Public health experts and officials have trained their sights on a new vape shop staple they fear could spur the next wave of the opioid epidemic. Department of Health and Human Services made a formal proposal to the DEA to classify 7-OH, a component of the pain reliever kratom, as a Schedule 1 substance, alongside heroin, LSD, and other drugs with no accepted medical use. While natural kratom contains only trace amounts of 7-OH, manufacturers have begun chemically isolating and concentrating it into a synthetic opioid-like drug estimated to be 10 to 13 times more potent than morphine. These ultra-potent extracts, often sold as gummies, shots and pills, now flood gas stations and vape shops with spotty age restrictions. FDA Commissioner Dr Marty Makary said: 'Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again.' The FDA's move was quickly followed by the Florida state attorney general James Uthmeier's decision to ban selling, having, or sharing 7-OH altogether, citing an 'immediate danger to the public health, safety and welfare.' The announcement makes Florida the first state to ban products containing 7-OH, which could set off a nationwide domino effect with more and more states following suit. 7-OH is a relative newcomer, and data on deaths are not well documented, but poison control center reports suggest it is growing rapidly more popular. The Pennsylvania Department of Health issued a warning earlier this month about it, noting 'increased call volume around both kratom and 7-OH consumption.' Pressed about 7-OH overdose risks, Makary cited scarce data and doctors' inability to identify it, while still calling the compound a 'killer,' far deadlier than plain kratom. The federal government has not tracked any deaths due to 7-OH specifically, though at least one has occurred. Matthew Torres, a 39-year-old Oregon carpenter, died from violent seizures in May 2021 after using kratom to manage chronic pain. His girlfriend found him foaming at the mouth at their Beavercreek home. The coroner ruled his death was caused by 'toxic effects of mitragynine (7-OH).' His mother Mary Torres is now pursuing a $10M wrongful death lawsuit against the smoke shop that sold it, alleging they failed to warn about risks. Jordan McKibban, 37, died in 2022 after consuming kratom powder purchased from an organic store, believing it to be a natural pain remedy. His death certificate listed 'toxic effects of mitragynine (kratom)' as the cause. Kratom has been used traditionally in Southeast Asia for centuries, and commercially sold in the US for decades as dried leaves or powders. Many states have different laws about the sale of kratom, limiting it to people either 18 and up or 21 and up. No federal age restrictions exist for 7-OH sales. Enforcement relies entirely on individual businesses. Most vendors voluntarily require ID for customers to confirm they are 18 and up or 21 and up, but this isn't mandated by law. 'We're not targeting the kratom leaf or ground-up kratom,' Makary said. 'We are targeting a concentrated synthetic byproduct that is an opioid.' While 7-OH is naturally present in small amounts from 0.6 percent to 0.7 percent on average in kratom leaves, modern extraction techniques have made it possible to create highly concentrated products, including shots, pills, and gummies. 7-OH tablets, for example, are pre-measured dosage forms containing concentrated amounts of the compound, typically ranging from 5mg to 22mg per tablet. An FDA-led report on 7-OH cited mounting research showing the extract acts like an opioid, hijacking the same brain receptors as morphine or prescription painkillers. In multiple experiments, 7-OH triggered strong 'mu-opioid' effects, the same pathway targeted by drugs like oxycodone, often with 13 times the potency of morphine and nearly double the strength of kratom's primary compound, mitragynine. When tested on cells and animal tissue, 7-OH behaved like a full opioid agonist, meaning it does not just mildly activate these receptors; it switches them on entirely, setting the stage for repeat, problem use in the future. The FDA's report added that 7-OH's effects were reversed with the anti-overdose nasal spray naloxone. Florida AG Uthmeier cited the FDA's findings in his decision to schedule the substance. He said: 'We are taking emergency action now because we see immediate danger. Last week the FDA commissioner issued a warning about 7-OH, putting people on notice to the dangers, calling on states to observe and take action where necessary. 'So here in Florida, we are not going to rest on our laurels. We move fast. We want to help lead the way when it comes to public safety.' By designating the potent kratom extracts as Schedule I drugs, the state now ranks them alongside heroin, LSD, and illegal fentanyl, deeming them equally dangerous with zero medical value. The emergency rule grants law enforcement and regulators immediate authority to raid gas stations and smoke shops statewide, seizing the products. Agriculture Commissioner Wilton Simpson, appearing alongside Uthmeier, told business owners to 'get it off your shelves.' 'We are going to be very aggressive,' he added. Makary, in turn, celebrated Uthmeier's decision in 'fighting back and educating Floridian parents, law enforcement professionals, teachers and community leaders about this threat to public health.' He added: 'I encourage other states to act now and use common sense regulation to safeguard the well-being of our youth and Make America Healthy Again.' Florida's decision to explicitly ban 7-OH is unprecedented, though several other states, including Colorado, Mississippi, Arizona, Oklahoma, Texas, and Utah have different restrictions on the concentration of 7-OH in the products. 'I am very supportive of people seeking alternatives outside of traditional Western medicine for wellness,' Florida Surgeon General Joseph Ladapo said. 'Our problem here is not with kratom. The problem today is with 7-OH. We don't need any more substances that disconnect people from reality.'
Daily Mail
24 minutes ago
- Daily Mail
Plastic surgeons reveal what could be behind Tom Brady's changing appearance
It's often said that Tom Brady has aged like fine wine, and on his 48th birthday this month the retired quarterback looked as suave as ever. To mark the occasion, the NFL shared 13 photos of the football legend showcasing his remarkably youthful features over his two-decade career. Now, plastic surgeon Dr Smita Ramanadham has analyzed the images to reveal whether he may have had any subtle work to enhance his features. 'With Brady, he is very much an example of plastic surgery done right,' she said. 'You want surgery where you can't quite tell what it is you got, and that is the case here. 'We can't stop aging no matter what we do, but I don't see those changes with Brady that I see with everyone else, even myself, and that makes me suspicious.' 'I think he's definitely had some 'tweakments,' small procedures, either surgical or nonsurgical, to maintain his looks so that he ages gracefully, but no major work.' She suggested he had likely received a barely-there surgery to remove skin around the eyes, a subtle nose job to slightly refine the nose, and Botox and fillers for lines. But much of his youthful appearance was down to his workout regimen and strict diet, she suggested. Since retiring, he has lost 10lbs and continues to avoid refined sugars, salt, caffeine, white flour and dairy. Other surgeons previously suggested to after looking at images of him that Brady had also received a facelift. Dr Ramanadham said this was possible, but added that the shift could similarly be down to his fitness regime, diet, skincare regimen and filler. Dr Ramanadham, who runs a clinic in New Jersey, based her analysis on pictures of the star over the years and did not examine him in person. Brady has not publicly addressed whether he has undergone plastic surgery. Daily Mail reached out to representatives for the football player but did not receive a response. Rumors about potential cosmetic enhancements, including Botox, a facelift and buccal fat removal, where fat is removed from the cheeks, have circulated for years. They were reignited in September 2024, when the NFL posted an Instagram video of Brady that triggered further comments about his youthful appearance. After viewing photos of the sporting legend, Dr Ramanadham was quick to suggest he may have had an upper bletharoplasty, or surgery to remove skin above the eyes. The skin is more prominent in his early photos from the 2000s, and would be expected to gradually droop over time in normal aging. But in photos, it stays in the same place. 'Really, the only way that could happen is that if he had a small upper bletharoplasty,' she said. 'He doesn't look like he has the super awake eyes that can result from the procedure, but there is no way he would have looked this way now, with virtually no change in the skin, without something being done.' Dr Ramanadham also pointed to Brady's nose, which she said appeared to become slightly more refined over the years. This suggested to her that he may have received a nose job, or rhinoplasty. She said: 'His nose appears to be more refined. As we progress through the years, his nostrils get slimmer and his nose tip definitely looks more refined.' NFL stars can break or fracture their noses on the field, which can then lead to them being referred to surgeons for cosmetic work. Brady injured his nose in a 2012 game against the Tennessee Titans, suffering a bloodied face after he was tackled from behind while holding the ball. He did not confirm whether he broke his nose at the time, but told reporters that he needed 'some scars' to boost his career. Dr Ramanadham said the tight skin around Brady's jawline was also unusual because the skin tends to sag in this area as people age. Brady is shown above early in his sporting career in 2001, left, and 2002, when he was about 24 and 25 years old The tight appearance suggested, she said, that Brady had used Botox or fillers injected along the jawline to boost its definition. Brady has also lost a significant amount of weight over the years, which could also be contributing to the tighter appearance. He has focused on fitness since retiring from the NFL, saying in a September 2023 episode of the SiriusXM show 'Let's Go!': 'Yeah, I'm down about 10lbs, but I'm actually very fit right now. 'I haven't had the stress that I had while I was playing, so that's allowed me to focus a little bit more on my physical health.' He added: 'It's just nice to feel good, to wake up every day and know that I'm taking care of myself in a different way.' Previously, surgeons told after looking at images of him that Brady had received a facelift to tighten his jawline. Dr Tijion Esho, a cosmetic surgeon and founder of Cultskin in the UK, said at the time that Brady's appearance was similar to that 'typically seen after a full face lift which is still in the process of healing'. While it is possible that he had a facelift, Dr Ramanadham said it was also possible that an excellent maintenance regimen and skincare routine could have contributed to the appearance. Overall, she said that it remained difficult to tell which procedures Brady had received, which is 'exactly what happens with excellent plastic surgery'. 'I am definitely less certain about these procedures compared to those of other stars,' she said.
BBC News
an hour ago
- BBC News
The Interview Captain Jim Lovell, Apollo 13 commander.
Captain Jim Lovell, commander of the doomed Apollo 13 space mission to the Moon. Jim, who died this month at the age of 97, tells how he helped guide his stricken craft safely back to Earth after it suffered a near catastrophic explosion in an interview first broadcast in April 2020 on the BBC series 13 Minutes to the Moon. He talks to Kevin Fong about the doomed Nasa mission, from the shocking moment of the explosion to the enormous relief of splashdown. Lovell shares the story of the lunar landmark he named in honour of his wife. And he reflects on survival, the global impact of Apollo 13, and what it meant to finally come back to Earth. (Image: Jim Lovell, Credit: Nasa)
