logo
Efimosfermin Leads to Significant MASH Improvement

Efimosfermin Leads to Significant MASH Improvement

Medscape09-05-2025

SAN DIEGO — Boston Pharmaceuticals' once-monthly efimosfermin alfa (formerly BOS-580) prescribed for metabolic dysfunction–associated steatohepatitis (MASH) with F2 and F3 fibrosis significantly improved MASH resolution and fibrosis after 24 weeks, according to results of a phase 2 trial presented at Digestive Disease Week (DDW) 2025.
An analogue of the fibroblast growth factor 21 (FGF21) protein, the agent regulates metabolic processes to reduce liver fat. It has a half-life of about 21 days, said study presenter Margaret J. Koziel, MD, chief medical officer at Boston Pharmaceuticals.
MASH is marked by inflammation and fibrosis and can progress to cirrhosis and liver failure. About 2%-5% of US adults have MASH, according to the American College of Gastroenterology. Up to 20% of adults who are obese may have the condition.
The researchers randomly assigned 84 participants with biopsy-confirmed F2/F3 MASH to receive once-monthly injections of 300 mg efimosfermin alpha (43 patients) or placebo (41 patients) for 24 weeks.
The mean body mass index (BMI) of participants in both groups was about 37. Most study sites were in the southern United States, so that BMI 'reflects the demographics,' Koziel said. Mean age was 55 years in the placebo group and 53 years in the treatment group, and about half of patients in both groups were women. Eighteen patients in each group had a fibrosis stage of F3.
Primary endpoints were safety and tolerability.
Exploratory objectives included the proportion of patients achieving fibrosis improvement of one or more stages without MASH worsening, MASH resolution without worsening of fibrosis, or both fibrosis improvement and MASH resolution.
Sixty-seven patients completed the treatment, and 65 post-baseline biopsies were collected — 34 in the placebo group and 31 in the treatment group.
Positive Results
'We saw statistically significant changes in fibrosis improvement,' Koziel said. 'This has been the hardest barrier to hit.'
After 24 weeks, 45% of patients in the treatment group and 21% in the placebo group showed fibrosis improvement of one or more stages without worsening of MASH ( P = .038), and 68% of those in the treatment group and 29% in the placebo group had MASH resolution without fibrosis worsening ( P = .002).
The between-group difference in fibrosis improvement and MASH resolution did not reach statistical significance, with 39% of patients in the treatment group and 18% in the placebo group achieving the combined endpoint ( P = .066). 'It just missed statistical significance,' Koziel said, but she viewed the outcome as meaningful.
Additionally, 'a third of the group taking efimosfermin normalized their liver fat, and all but one normalized their liver enzymes,' she said.
Adverse events — most often nausea, vomiting and diarrhea — were mild to moderate in both groups, Koziel said. In the treatment group, one patient withdrew from the study due to a grade 3 serious adverse event, and two others did so due to low-grade adverse events.
'These data support further development of once-monthly efimosfermin for the treatment of MASH-related fibrosis,' the research team concluded.
Hopeful Development
'Finally, there's hope,' said DDW attendee Na Li, MD, associate clinical professor of internal medicine at Ohio State University Wexner Medical Center, Columbus, Ohio, whose clinical focus is on metabolic-associated steatotic liver disease.
The new hope, she said, refers not only to the phase 2 study results but to the Food and Drug Administration approval of resmetirom (Rezdiffra) last year, which reduces liver fat by stimulating thyroid hormone receptor beta. 'That was the first medication that got approved with a specific indication to treat MASH,' she said. Before that, lifestyle measures aimed at weight loss were the only approach.
Lifestyle measures are still important, Li said, but it's helpful to have additional options. 'There are quite a few agents in the pipeline now,' she said. One example is another FGF21 analogue efruxifermin, which is in phase 3 trials.

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Female tennis players granted WTA ranking protection during fertility procedures
Female tennis players granted WTA ranking protection during fertility procedures

Fox News

time16 minutes ago

  • Fox News

Female tennis players granted WTA ranking protection during fertility procedures

The WTA will now protect the rankings of female tennis pros who take time away from competition to undergo fertility protection procedures, the tour announced Wednesday. The player-led measure will allow female tennis players to use a special entry ranking (SER) for up to three tournaments if they choose to undergo a "fertility protection procedure such as egg or embryo freezing." "By introducing this new form of ranking protection, the WTA helps to support and empower women athletes to balance a professional sports career with planning and starting a family at a time of their choice," the tour said in a news release Wednesday. The new measure adds to the WTA's Family Focus Program, which already includes ranking protection during pregnancies or other means of parenthood and postpartum support. It also follows the WTA's announcement in March that tennis players on tour can receive 12 months of paid maternity leave. "I'm incredibly proud of our sport in recognizing the importance of fertility treatments for female athletes," 2017 U.S. Open champion Sloane Stephens said in a statement provided by the tour. "For any woman, the conversation of family life versus a career is nuanced and complex. The WTA has now created a safe space for players to explore options and to make the best decisions for themselves. It's truly groundbreaking and will empower this generation, and future generations of players, to continue with the sport they love without having to compromise." Speaking to the BBC, Stephens explained her own experiences and the challenges she faced under the previous rules. "The first time I did it, I rushed back, and I was overweight and not happy and just very stressed out," she told the outlet. "The second time I did it, I took a totally different approach so I could just be in better shape. I could have the surgery. I could have more time to recover. "Having the protected ranking there, so that players don't feel forced to come back early and risk their health again, is the best thing possible." The SER will be based on the 12-week average of the player's WTA ranking from eight weeks prior to the start of their out-of-competition period. Follow Fox News Digital's sports coverage on X, and subscribe to the Fox News Sports Huddle newsletter

How UT Dallas researchers are helping spinal injury patients reclaim their lives
How UT Dallas researchers are helping spinal injury patients reclaim their lives

CBS News

time17 minutes ago

  • CBS News

How UT Dallas researchers are helping spinal injury patients reclaim their lives

With a tablet propped up in front of him and a joystick-like device in hand, Marshall Bell looks like he's playing a video game. But it's actually physical therapy — powered by innovative, Texas-developed technology that's changing his life. "I can officially shampoo my hair with my injured arm," said Bell, 35, of Arlington, with a smile. "It might take a while, but I am just ecstatic to be able to get it to touch my —" he said, moving his hand to his head to demonstrate. Life changed by hit-and-run Marshall Bell, 35 CBS News Texas In 2016, Bell was hit by a car while walking along a Fort Worth street. The driver didn't stop. Bell was left with a partially severed spine and a devastating prognosis. "His name was Dr. Gundy," said Bell. "He pulled my father into the room and told him, 'You need to make arrangements for your son. He might not be able to do anything on his own ever again.'" At the time, Bell could only move his index finger. But he was determined to recover. Over time, he regained the ability to walk—but he wanted more. UT Dallas leads breakthrough Bell joined a groundbreaking study led by researchers at the University of Texas at Dallas. The study centers on a tiny, implantable device that stimulates the vagus nerve during physical therapy. "That's the device," said Robert Rennaker, Ph.D., a retired Marine turned neuroscience professor and inventor. "It's just a little circuit board inside some glass." Tiny device, big results The device is implanted through a small incision in the neck and zip-tied to a nerve. It doesn't require batteries, is MRI-safe, and is charged externally with a device that resembles headphones. "I can't feel it at all," said Bell. "In the test trials, I thought I had the placebo. Then they pressed it, and I felt the shock. I was like, 'Oh, all right, it's there!'" Rewarding the brain's effort During therapy, the device stimulates the vagus nerve to reward successful movements. "I always tell people, I like to golf. I hit the ball well, and I'm like, yeah!" said Rennaker. "We're doing that, but we're doing it artificially." "It's not exciting to relearn how to pick up a cup or put in an earring," said Jane Wigginton, M.D., chief medical officer at the Texas Biomedical Device Center at UT Dallas. "So we give them that same little zap to the vagus nerve that releases those same chemicals. It lays down that pathway so it gets easier and easier." Hope for long-term injuries Wigginton said the study has shown unprecedented recovery rates for spinal cord injuries, regardless of how much time has passed. She cited examples like Hal, who is now able to point and type 40 years after his injury, and Amanda, who can now put on earrings by herself. "In my mind, it's like a miracle," said Wigginton. Years of research pay off The research builds on more than a decade of neuroscience and bioengineering work at UT Dallas. Previous studies showed that vagus nerve stimulation during therapy could rewire the brain after a stroke. Now, the same approach is helping spinal cord injury patients make progress once thought impossible. "I can officially dress myself completely," said Bell. "And I can fully open mason jars now! It's the little things." Texas at the forefront The Communities Foundation of Texas funded the initial production of the implantable devices. Researchers are continuing to fundraise and conduct clinical trials as they pursue full FDA approval, which they hope to achieve in the next three to four years. "It's going to make North Texas the center of the universe in this sort of research," said Wigginton. "It absolutely will. It's that big." The goal, researchers say, is to help patients reclaim their lives. "I would say that is dead on what this is doing," said Bell.

Taming Wild Fires Before They Spiral - Part 1: Solutions
Taming Wild Fires Before They Spiral - Part 1: Solutions

Forbes

time28 minutes ago

  • Forbes

Taming Wild Fires Before They Spiral - Part 1: Solutions

PACIFIC PALISADES, CALIFORNIA - JANUARY 30: In an aerial view, neighborhoods lie in ruins after the ... More Palisades Fire on January 30, 2025 in Pacific Palisades, California. (Photo by Qian Weizhong/VCG via Getty Images) Its heartbreaking. Losing your home, your neighborhood, your memories, your relationships. A series of 14 destructive wildfires affected the Los Angeles metropolitan area in California in January 2025. The ensuing devastation killed at least 30 people, forced more than 200,000 to evacuate, destroyed more than 18,000 homes and structures, and burned over 57,000 acres of land in total. The costs and time to rebuild are staggering - in the $100Bs and ~ 10 years. The deaths and damage to property from these fires made them likely among the most destructive fires in California's history How do we tame these fires these before they spiral out of control? a startup out of TechStars L.A. accelerator, uses publicly available social media content with a proprietary data science and AI platform to predict and understand customer trends and sentiments. (Disclosure: I am an advisor to They had previously used their platform to analyze consumer sentiments on the rapidly progressing revolution of autonomous (driverless) cars. For this article, they analyzed ~300K social media posts during the January-February 2025 period to reveal thoughts and recommendations from the public for managing future wild fires. These are listed below: The first insight is the most effective and subject of Part 1 of this article (the sensing and AI solution). Part 2 will report user experience of this capability (Florida Forest Service and San Bernardino County, California Fire Protection District). Fire Neural Network (FNN) is a venture backed company that germinated out of research in 2021 at the University of Florida. It was co-founded by Dr. Istvan Kereszy and Caroline Comeau. Wildfires can be caused by natural (electrical transmission failures and lightning) as well as human (arson, vehicle accident, etc.) events. In many parts of the United States, lightning is a dominant cause of natural wildfires (over 50% of such fires according to ESRI). Lightning creates a continuing current with durations ranging from tens to hundreds of milliseconds and exhibit amplitudes from several tens to a few hundreds of amperes. The core intellectual property that FNN has commercialized is the High Risk Lightning Detector (Figure 1) which detects these current profiles over a 20 mile radius and within 40 seconds of the strike. Figure 1: FNN's Terrestrial Solar Powered High-Risk-Lightning Detector Has a Detection Radius of 20 ... More m and Can Identify Lightning Strikes Within 40 Seconds FNN deploys a network of such detectors in wildfire prone areas for commercial and government customers in the United States as well as internationally. Real-time data from these sensor networks is combined with GIS (Geographical Information Systems) to integrate location specific weather and vegetation data into a trained AI (Artificial Intelligence) engine to assess wildfire risk due to lightning strikes (Figure 2). Time and accuracy are of the essence here - early detection (within 40 seconds) and notifications help get fire-fighting resources to the right locations to eliminate wildfires before they spin out of control. Figure 2: FNN Uses Real-TIme Sensor Data and Location Specific Weather and Vegetation Information ... More Within an AI Engine to Issue Lightning Alerts to Fire-Fighting Agencies Within 40 Seconds Foreflight is FNN's tablet-based wildfire alert application issued to fire fighting agencies along with high risk locations. This enables quick verification and containment of the highest risk wildfire sites before they spread and spiral out of control (Figure 3): Figure 3: Florida Forest Service Pilots Use FNN's High-Risk-Lightning Map in ForeFlight to Detect, ... More Locate, Verify and Contain Wildfire Hotspots The State of Florida has one of the highest rates of lightning in the United States. This, combined with the amount of foliage and weather conditions makes lightning-related wildfires essentially an all-year phenomenon, with peak activity in spring (February-June) when the weather is dry. Fighting wildfires through use of technology is a state government priority. The non-profit XPRIZE Foundation (established in 1994) which has hosted competitions to address global challenges announced the XPRIZE Wildfire in 2021, a 4-year, $11 million competition is meant to incentivize the innovation of autonomous and time sensitive wildfire management technologies. FNN is one of the finalists in this competition through the GatorX team which includes the University of Florida, NVIDIA, SATLANTIS (satellite imaging), SwissDrones, Phenix Systems and Archer (Drones), N5 and SWIR Vision (Sensors) to identify, locate, assess and eliminate wildfire germinations autonomously, without compromising human safety. The HiPerGator, a NVIDIA equipped AI computing platform established by NVIDIA co-founder Chris Malachowsky (a University of Florida alumnus) plays a critical role in absorbing the terabytes of video, climate, vegetation, communication, location and sensor data, and providing actionable information to drone-based, fire verification and mitigation platforms. SwissDrones, based in Zurich, was founded in 2013 by ex-pilots and aviation experts to develop and sell drones to oil, gas, and utility companies to inspect pipelines and infrastructure in remote areas, as well as to civil authorities for search and rescue missions. The drones are VTOL (Vertical Takeoff and Landing), twin rotor autonomous helicopters powered with aviation turbine engines, and have a take-off weight of ~200 lb (fuel + payload), speeds of ~30 mph and mission range of ~50 miles (Figure 4). This enables BVLOS (Beyond Visual Line of Sight) operation to cover broad geographic regions for day and nightime operation. The drones are equipped with precision navigation and GPS sensors, and incorporate multiple payloads (as required by the customer and their application) including infrared and mid-wave (3-5 um wavelength) thermal cameras, and LiDAR imaging for 3D awareness and mapping. As a partner on the GatorX team, the role of the SwissDrone platform is to fly to the location indicated by the FNN ForeFlight application and confirm whether the fire threat is real. If it is, the information triggers firefighting action by specialized aerial drones and ground-based fire fighting teams. Figure 4: SwissDrone Autonomous Helicopter on a Search and Rescue Mission Phenix Solutions, founded in 2011 by ex-pilots and aviation professionals is based in Oregon and 'delivers game changing aircraft worldwide in order to save lives and maximize demand on command'. The company specializes in design and manufacture of heavy lift (above 3,000 lbs payload) Remotely Piloted Aircraft (RPA) for various civil, defense, firefighting, search/rescue, disaster management and construction applications. It is a member of the GatorX program with FNN and others. Once prompted by inspection drones like SwissDrones of the verification and location of wildfires, the Phenix drone deploys and commences mitigation actions (Figure 5). Figure 5: Phenix Ultra 2XL is Designed as a Fire Fighting Solution to Provide Initial Suppression ... More and Contain Wildfires Equipped with Rolls Royce engines, its VTOL drone-helicopters can carry and dispense 3000 lb containers of liquid firefighting solutions at targeted locations to extinguish fires before they spiral out of control. Their vehicles are FAA certified and used in firefighting and other hazardous applications to prevent loss of human life, and respond quickly to threats before they escalate. In current operation, a human pilot plans and controls the flight path. The eventual goal is to use AI and sensor data to achieve full autonomy. The causes of wildfire can be due to human (intentional or unintentional) causes. But as the 2025 Los Angeles fires show, the impact is devastating. Using advanced sensors, imaging, AI and autonomy to locate, verify and suppress fires at their origination is critical and can return huge benefits. The operational process flow is complex but achievable. Part 2 of this article will report user experience of this capability (Florida Forest Service and San Bernardino County, California Fire Protection District).

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store