EXTON, PA, Aug. 28, 2025 (GLOBE NEWSWIRE) -- The recent approval of Novo Nordisk’s Wegovy (semaglutide 2.4mg) as the second treatment for metabolic dysfunction-associated steatohepatitis (MASH) represents a critical step forward in a condition with a vast patient population and significant unmet need. Highly anticipated by the field, this milestone is expected to transform the future of MASH care.  Findings from a Spherix Global Insights pulse study among gastroenterologists and hepatologists (n=77) conduct ...

Core Insights - The publication of the 96-week results from the Phase 2b HARMONY trial indicates the potential of efruxifermin (EFX) to significantly reduce the risk of fibrosis progression in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) [1][2][3] Company Overview - Akero Therapeutics, Inc. is a clinical-stage company focused on developing treatments for serious metabolic diseases, particularly MASH, which has a high unmet medical need [1][12] - Efruxifermin (EFX) is Akero's lead product candidate, currently being evaluated in three ongoing Phase 3 studies targeting different stages of MASH [9][12] Trial Results - The HARMONY trial was a 96-week multicenter, randomized, double-blind, placebo-controlled study involving 128 adult participants with biopsy-confirmed MASH and moderate to advanced fibrosis [2][11] - In the mITT population at week 96, 49% of participants receiving 50mg EFX achieved at least one stage of fibrosis improvement without worsening of MASH, compared to 19% for placebo (p=0.0030) [3][4] - Improvements in fibrosis were also noted in patients with more advanced disease, indicating EFX's potential effectiveness across different stages of MASH [3][4] Secondary Endpoints - The secondary endpoint of MASH resolution without fibrosis worsening was achieved by 40% of participants receiving 28mg EFX and 37% receiving 50mg EFX, compared to 19% for placebo [4] - A composite endpoint of both MASH resolution and at least one stage of fibrosis improvement was met by 35% and 28% of participants in the 50mg and 28mg EFX groups, respectively, versus 7% for placebo [4] Safety and Tolerability - EFX was generally well tolerated, with a safety profile consistent with previous trials; the most common adverse events were mild to moderate gastrointestinal issues [6] - A small reduction in bone mineral density was observed after 96 weeks of EFX treatment, although the clinical significance of this finding remains to be determined [6] Overall Impact - The sustained reductions in fibrosis and MASH observed in the trial reflect an overall improvement in whole-body metabolic health, including reduced dyslipidemia and increased insulin sensitivity [7] - The results from the HARMONY trial, along with data from the SYMMETRY trial, suggest that EFX has the potential to transform patient outcomes, particularly for those with a high fibrosis burden [3][7]

Core Insights - Akero Therapeutics reported significant advancements in its clinical program for Efruxifermin (EFX), particularly in reversing compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) as demonstrated in the Phase 2b SYMMETRY trial [1][2][7] Financial Performance - As of June 30, 2025, Akero had cash, cash equivalents, and short-term marketable securities totaling $1,086.2 million, which is expected to fund operations into 2028 [1][13] - Research and development expenses for Q2 2025 were $69.3 million, up from $55.3 million in Q2 2024, attributed to ongoing Phase 3 studies and increased personnel costs [13] - General and administrative expenses rose to $11.6 million in Q2 2025 from $10.4 million in Q2 2024, reflecting higher personnel and professional service costs [13] - Total operating expenses for Q2 2025 were $80.9 million, compared to $65.7 million in the same period of 2024 [13] Clinical Developments - The Phase 2b SYMMETRY trial results were published in the New England Journal of Medicine, reinforcing EFX's potential as a first- and best-in-class therapy for advanced-stage MASH [7] - EFX demonstrated the ability to reverse cirrhosis in high-need subgroups, including patients with cryptogenic cirrhosis and type 2 diabetes, marking a significant milestone in treatment options [7] - The Phase 2b HARMONY study also showed consistent improvements in fibrosis for patients with pre-cirrhotic MASH, utilizing both conventional and AI-based analysis methods [7] Market Context - MASH affects an estimated 17 million Americans, with approximately 20% of patients expected to progress to cirrhosis, highlighting the urgent need for effective treatments [8] - By 2030, it is projected that 3 million Americans will have cirrhosis due to MASH, emphasizing the growing public health challenge [9]

Core Insights - Madrigal Pharmaceuticals (MDGL) shares increased by 10.9% following the U.S. Patent and Trademark Office's Notice of Allowance for a new patent related to the FDA-approved dosing regimen of its product Rezdiffra (resmetirom) [1][7] Company Developments - In 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and only approved therapy for metabolic dysfunction-associated steatohepatitis (MASH) [2] - The new patent will protect Rezdiffra until September 30, 2044, and will be listed in the FDA's Orange Book, preventing generic competition and enhancing market exclusivity [3][7] - As of March 31, 2025, over 17,000 patients are currently receiving Rezdiffra treatment, indicating strong early demand [4][7] Clinical Pipeline - Madrigal Pharmaceuticals is awaiting a final decision on its regulatory filing for Rezdiffra for the MASH indication in the EU, expected in August [8] - The ongoing pivotal phase III MAESTRO-NASH biopsy study aims to provide long-term safety and efficacy data to support full approval of Rezdiffra for noncirrhotic MASH [9] - A second phase III outcomes study (MAESTRO-NASH OUTCOMES) is evaluating the drug's effectiveness in patients with compensated MASH cirrhosis, with top-line data expected in 2027 [10] - The open-label extension of the MAESTRO-NAFLD-1 study shows that patients treated with Rezdiffra achieved significant reductions in liver damage over two years [11][12] Market Performance - Year-to-date, MDGL shares have gained 11.8%, outperforming the industry growth of 6.3% [6]