Efimosfermin Leads to Significant MASH Improvement
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.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Health Line
an hour ago
- Health Line
How Much Caffeine Does Tea Have Compared with Coffee?
While black tea, espresso, and coffee bring the most caffeine to the table, green tea packs a moderate amount as well. The content in white teas varies greatly, while herbal teas are practically caffeine-free. Caffeine's popularity as a natural stimulant is unparalleled. It's found in over 60 plant species and enjoyed across the globe, especially in coffee, chocolate, and tea. The caffeine content in a beverage varies depending on the ingredients and how the drink is prepared. While caffeine is considered safe, drinking too much may raise some concerns. Let's compare the caffeine contents of various teas and coffees and explore which drink you should choose. Why is caffeine a concern? An estimated 80% of the world's population enjoys a caffeinated product daily. Both the U.S. Department of Agriculture (USDA) and European Food Safety Authority (EFSA) define a safe caffeine intake as up to 400 mg per day, 200 mg per single dose, or 1.4 mg per pound (3 mg per kg) of body weight. Due to its stimulating effects, caffeine has been linked to health benefits like enhanced alertness, improved athletic performance, elevated mood, and increased metabolism. That said, consuming high amounts — such as single doses over 500 mg — may raise some concerns. In large doses, caffeine has been associated with anxiety, restlessness, and difficulty sleeping. In addition, a 2019 study suggests that drinking it regularly, even in moderate amounts, can cause chronic headaches and migraine episodes. Furthermore, caffeine is considered mildly addictive, and some people may be more susceptible to developing a dependence. Caffeine content varies by beverage type and preparation The amount of caffeine in tea or coffee can vary significantly depending on the origin, type, and preparation of the drink. Tea leaves contain 4% caffeine, while coffee beans have 0.9% to 2.6%. However, the coffee brewing process uses hotter water, which extracts more of the caffeine from the beans. Typically, you also use more coffee beans than you'd use tea leaves for a drink. Therefore, 1 cup (237 ml) of brewed coffee generally has more caffeine than a cup of tea. Tea varieties Black, green, and white teas are prepared from leaves of the same plant, Camellia sinensis. What sets them apart is the time of harvest and level of oxidation of the leaves. Black tea leaves are oxidized (especially exposed to oxygen for a longer amount of time), while white and green tea leaves are not. This gives black tea a characteristic bold and sharp flavor. An average cup (220 ml) of black tea packs 50 mg of caffeine but can contain more. For comparison, green teas contain up to 45 mg, while white teas deliver an average of 16.79 mg per gram (mg/g). According to some studies, white tea contains less caffeine than green tea. Matcha green tea is another high-caffeine tea. It usually comes in powdered form and packs 18.9 to 44.4 mg of caffeine per half-teaspoon (1-gram) serving. Similarly, yerba mate, a tea traditionally enjoyed in South America that's made by steeping the twigs and leaves of the Ilex paraguariensis plant, usually contains about 80 mg of caffeine per cup. While technically not made from tea leaves, herbal teas are a nice caffeine-free beverage choice. Tea preparation The preparation method greatly impacts the caffeine content of tea. Teas that steep for longer and in hotter water tend to produce a more potent cup. One 2024 study concluded that the best conditions to extract caffeine were at 212°F (100°C) for 30 minutes. The researchers extracted: 0.089 g of caffeine from black tea 0.06 g from used black tea 0.08 g from green tea 0.047 g from used green tea Coffee varieties An average 8-ounce (237-ml) cup of coffee contains 90 to 200 mg of caffeine. It's a common belief that coffee made from dark-roasted beans has more caffeine than coffee from light-roasted beans. However, since caffeine isn't affected much by roasting, this may not be the case. That said, since dark roast coffees are less dense than light roast ones, you may use greater amounts of beans or grounds when brewing this type, yielding more caffeine per cup. Espresso is a more concentrated source of caffeine. A single shot of espresso has about 127 mg of caffeine. Some specialty coffee drinks, such as lattes and cappuccinos, are made with a double shot of espresso. Coffee preparation Hot water draws more caffeine out of tea leaves in a shorter period of time, and the same holds for coffee. Coffee is typically brewed at a temperature of about 195 to 205°F (90 to 96°C). You can also make cold-brewed coffee by soaking ground coffee in cold, filtered water for 8 to 24 hours. As you use 1.5 times more ground coffee using this method compared with regular hot-water brewing, it may result in a more caffeinated cup. Which one should you drink? Caffeine acts quickly — usually within 45 minutes of consumption. If you're sensitive to the effects of caffeine, consider sticking to teas lower in caffeine like white or herbal teas. You may also brew high-caffeine teas for a shorter time, such as 1 minute instead of 3. Opting for decaffeinated tea or coffee is also a good way to enjoy these drinks without much caffeine. On the contrary, if you're a fan of high-caffeine drinks, you may enjoy espresso, cold-brew coffee, and teas with higher caffeine contents, including green and black varieties. To stay within safe amounts, drink no more than 400 mg daily, or 200 mg of caffeine at a time. This translates to no more than three to five 8-ounce (237 ml) cups of regular coffee daily, or eight 1-ounce (30-ml) shots of espresso. Those who have heart disease, are prone to migraine episodes, and take certain medications should limit their caffeine intake.
Yahoo
2 hours ago
- Yahoo
CancerVax Targets Liver Cancers to Further Showcase Flexibility of Its Universal Platform
Using AI machine learning, the Company discovers distinct biomarkers for detecting certain rare liver cancers that have stem cell characteristics and will include them as additional indications in its preclinical program Lehi, Utah, June 09, 2025 (GLOBE NEWSWIRE) -- CancerVax, Inc., the developer of a breakthrough universal cancer treatment platform designed to use the body's immune system to treat cancer, today announced that it will expand its preclinical program to include liver cancers, specifically rare stem cell-like forms of hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC). Patients with these stem cell-like tumors have a significantly worse survival than patients with more traditional liver tumors. CancerVax's novel platform uses engineered lipid nanoparticles to detect and mark only cancer cells for destruction by the immune system. The nanoparticles use a 2-step detection mechanism to precisely target cancer cells, while leaving healthy cells unharmed. The nanoparticles first target cells with specific surface proteins ('Marker1'), then release proprietary Smart mRNAs that are activated only in the presence of cancer-specific signatures ('Marker2'). Once activated, the mRNA forces cancer cells to express proteins associated with well-immunized diseases like measles, effectively tricking the immune system into killing cancer cells as if they were common diseases. The Company previously announced that it was targeting pancreatic ductal adenocarcinoma (PDAC) in its preclinical program. After extensive research and AI-driven analysis, the Company's scientific team has discovered a very distinct Marker2 signature for a group of rare liver cancers. These tumors have stem cell characteristics, making them more aggressive and less responsive to traditional therapies. By taking advantage of the distinct Marker2 signature, CancerVax believes it can overcome the severe unmet clinical need for these cancer patients and can more quickly validate the universality of its platform. The Company's preclinical cancer indications will now be expanded to three (3) cancer types: PDAC, rare HCC and ICC. Dr. Adam Grant, Principal Scientist of CancerVax said, "When we first identified these subsets of liver cancers with this distinct Marker2 signature, I couldn't believe it. It was amazing to come across a patient population that has a high unmet clinical need and is uniquely suited to validate our technology. Of course, we expect that our platform will work on many different cancer types but the unique genetic signatures in these rare liver cancers make them a no-brainer for us to target. This precision-based discovery is what every computational biologist dreams of and I'm beyond excited to have the opportunity to help provide relief for these patients with severely poor outcomes. Dr. George Katibah, Chief Scientific Officer of CancerVax said, "The results from our AI data analytics are really striking. This particular cancer biology leads to not one but a group of rare liver cancers for which there are limited treatments. Our team has uncovered this novel cancer stem cell biology using advanced computational techniques showing that these tumors' underlying biology can be targeted by the CancerVax approach. These results demonstrate the flexibility of our platform and how we can swap out Marker1 and Marker2 to attack other cancers with a precision medicine approach. The next steps include creating new nanoparticles for these new cancer indications and to perform in vitro and in vivo studies to evaluate efficacy and safety.' The Company's universal cancer treatment platform is architected in such a way that off-the-shelf injections can be created by changing the Marker1 and Marker2 combination to target different cancer types. This approach allows for the Company's immunotherapies to be broadly available when a patient is diagnosed and needs to be treated immediately. These injections are more like 'off-the-shelf' flu shots, rather than complex treatment procedures. About CancerVax CancerVax is a pre-clinical biotech company developing a novel Universal Cancer Treatment platform that will be customizable, as an injection, to treat many types of cancer. Our innovative approach DETECTS, MARKS, and KILLS only cancer cells. By making cancer cells look like well-immunized common diseases such as measles or chickenpox, we intend to use the body's natural immune system to easily kill the cancer cells. We look forward to the day when treating cancer will be as simple as getting a shot -- a better way to fight cancer. To learn more, please visit Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside our control. Our actual results and financial condition may differ materially from those in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us in this release is based only on information currently available to us and speaks only as of the date it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise. Press Contact:CancerVax, (805) 356-1810Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
2 hours ago
- Yahoo
Eric Adams signs executive order adopting Holocaust remembrance group's definition of antisemitism
Mayor Eric Adams signed an executive order Sunday adopting the International Holocaust Remembrance Alliance's definition of antisemitism, as he vowed to ramp up the city campaign to combat Jew hatred. He also introduced legislation urging the City Council to approve the IHRA definition, which would make it official law. The IHRA definition is considered by many Jewish leaders to be the standard in fighting antisemitism. 'Antisemitism is a certain perception of Jews, which may be expressed as hatred toward Jews. Rhetorical and physical manifestations of antisemitism are directed toward Jewish or non-Jewish individuals and/or their property, toward Jewish community institutions and religious facilities,' the IHRA definition states. Adams announced the order during a discussion with Dr. Phil Sunday night at the Tribeca Synagogue. It comes as he faces re-election and plans to run as an independent on an 'End Semitism' ballot line. 'Antisemitism is a vile disease that's been spreading across our nation and our city. What's worse, since Hamas' terror attacks on October 7, 2023, we have seen this hateful rhetoric become normalized on our campuses, in our communities, and online as antisemitic propaganda far too often masquerades as 'activism,'' Adams said. More than half of the hate crimes reported in the city in March victimized Jews, even though they account for just 11 percent of the population, the mayor noted. 'We know this moment demands bold, decisive action to crack down on anti-Jewish hatred,' Adams said. 'Today, we signed a landmark executive order to adopt an internationally recognized definition of antisemitism, but we must go further. I am calling on the City Council to join this commitment to target antisemitism everywhere it exists and immediately pass a bill to codify this definition into law. It's time we all come together to eradicate this hatred from our city, once and for all.' At the state level, former Gov. Andrew Cuomo — who's also running for mayor — issued an order barring state entities from doing business with firms that back the boycott, divestment and sanctions movement against Israel before his resignation. Gov. Kathy Hochul has retained the policy. State Comptroller Tom DiNapoli has his own pro-Israel policy. In 2021, he announced that he pulled $111 million in investments out of the firm that owns Ben & Jerry's because of the ice cream maker's boycott of Israel's occupied territories. DiNapoli is the sole manager of the $274 billion state Common Retirement Fund.
