Akero Therapeutics Announces Lancet Publication of the Phase 2b HARMONY Clinical Trial Demonstrating 96 Weeks Treatment with EFX Reduced Liver Fibrosis in Patients with Pre-cirrhotic MASH
Akero Therapeutics (Nasdaq: AKRO) published 96-week results from its Phase 2b HARMONY trial in The Lancet, evaluating efruxifermin (EFX) in patients with pre-cirrhotic MASH. The trial demonstrated significant efficacy with 49% of patients receiving 50mg EFX achieving at least one stage fibrosis improvement compared to 19% for placebo.
Key findings include 40% and 37% of patients achieving MASH resolution in the 28mg and 50mg groups respectively, versus 19% for placebo. The composite endpoint of MASH resolution and fibrosis improvement was met by 35% and 28% of participants in the 50mg and 28mg groups. Notably, 92% of week 24 responders maintained their response at week 96.
EFX was generally well-tolerated, with mainly mild to moderate gastrointestinal events reported. The results support EFX's potential to reduce disease progression in MASH patients.
Akero Therapeutics (Nasdaq: AKRO) ha pubblicato su The Lancet i risultati a 96 settimane del trial di fase 2b HARMONY, che ha valutato efruxifermin (EFX) in pazienti con MASH precirrotica. Lo studio ha mostrato un鈥檈fficacia significativa con il 49% dei pazienti trattati con 50 mg di EFX che ha ottenuto un miglioramento di almeno uno stadio di fibrosi, rispetto al 19% per il placebo.
I principali risultati includono il 40% e il 37% dei pazienti che hanno raggiunto la risoluzione della MASH nei gruppi 28 mg e 50 mg rispettivamente, contro il 19% nel gruppo placebo. L'endpoint composito di risoluzione della MASH e miglioramento della fibrosi 猫 stato raggiunto dal 35% e 28% dei partecipanti nei gruppi 50 mg e 28 mg. Da notare che il 92% dei responder a settimana 24 ha mantenuto la risposta alla settimana 96.
EFX 猫 stato generalmente ben tollerato, con eventi gastrointestinali prevalentemente lievi o moderati. I risultati supportano il potenziale di EFX nel ridurre la progressione della malattia nei pazienti con MASH.
Akero Therapeutics (Nasdaq: AKRO) public贸 en The Lancet los resultados a 96 semanas del ensayo fase 2b HARMONY, que evalu贸 efruxifermin (EFX) en pacientes con MASH precirr贸tica. El ensayo demostr贸 eficacia significativa, con un 49% de los pacientes que recibieron 50 mg de EFX logrando al menos una mejora de un estadio de fibrosis, frente al 19% con placebo.
Los hallazgos clave incluyen que el 40% y el 37% de los pacientes lograron la resoluci贸n de la MASH en los grupos de 28 mg y 50 mg respectivamente, frente al 19% del placebo. El endpoint compuesto de resoluci贸n de MASH y mejora de la fibrosis se cumpli贸 en el 35% y 28% de los participantes en los grupos de 50 mg y 28 mg. Cabe destacar que el 92% de los respondedores a la semana 24 mantuvo su respuesta en la semana 96.
EFX fue generalmente bien tolerado, con eventos gastrointestinales principalmente leves a moderados. Los resultados respaldan el potencial de EFX para reducir la progresi贸n de la enfermedad en pacientes con MASH.
Akero Therapeutics (Nasdaq: AKRO)電� The Lancet鞐� Phase 2b HARMONY 鞁滍棙鞚� 96欤� 瓴瓣臣毳� 氚滍憸頄堨溂氅�, 鞚� 鞐瓣惮電� 臧勱步氤� 鞝勲嫧瓿� MASH 頇橃瀽鞐愳劀 鞐愴攧耄╈嫓韻茧(EFX)鞚� 韽夑皜頄堨姷雼堧嫟. 頃措嫻 鞁滍棙鞚� 50mg EFX 韴棳甑办潣 49%臧� 靹湢頇旉皜 斓滌唽 頃� 雼硠 鞚挫儊 順胳爠霅橂姅 霌� 鞙犾潣頃� 鞙犿毃靹膘潉 氤挫榾瓿�, 鞙勳暯甑办潃 19%鞐� 攴胳长鞀惦媹雼�.
欤检殧 瓴瓣臣搿滊姅 28mg 氚� 50mg 甑办棎靹� 臧侁皝 40%鞕� 37%鞚� 頇橃瀽臧� MASH 甏�頃措ゼ 雼劚頃� 氚橂┐ 鞙勳暯甑办潃 19%鞓�雼る姅 鞝愳澊 鞛堨姷雼堧嫟. MASH 甏�頃� 氚� 靹湢頇� 順胳爠鞚� 氤淀暕鞝侅溂搿� 韽夑皜頃� 膦呺鞝愳潃 50mg 氚� 28mg 甑办棎靹� 臧侁皝 35%鞕� 28%鞚� 彀戈皜鞛�臧� 於╈”頄堨姷雼堧嫟. 欤茧頃� 鞝愳溂搿� 24欤� 鞁滌爯鞚� 氚橃潙鞛� 欷� 92%臧� 96欤� 鞁滌爯鞐愲弰 氚橃潙鞚� 鞙犾頄堨姷雼堧嫟.
EFX電� 欤茧 瓴届鞐愳劀 欷戨摫霃勳潣 鞙勳灔甏�瓿� 鞚挫儊氚橃潙鞚� 氤挫榾鞙茧┌ 鞝勲皹鞝侅溂搿� 雮挫暯靹膘澊 鞏戫樃頄堨姷雼堧嫟. 鞚� 瓴瓣臣電� MASH 頇橃瀽鞐愳劀 歆堧硲 歆勴枆鞚� 鞝�歆�頃� 靾� 鞛堧姅 EFX鞚� 鞛犾灛霠レ潉 歆�歆�頃╇媹雼�.
Akero Therapeutics (Nasdaq: AKRO) a publi茅 dans The Lancet les r茅sultats 脿 96 semaines de l'essai de phase 2b HARMONY, 茅valuant l'efruxifermin (EFX) chez des patients atteints de MASH pr茅cirrhotique. L'essai a montr茅 une efficacit茅 significative, avec 49% des patients ayant re莽u 50 mg d'EFX pr茅sentant une am茅lioration d'au moins un stade de la fibrose contre 19% pour le placebo.
Les r茅sultats cl茅s incluent 40% et 37% des patients obtenant la r茅solution de la MASH dans les groupes 28 mg et 50 mg respectivement, contre 19% pour le placebo. Le crit猫re composite de r茅solution de la MASH et d'am茅lioration de la fibrose a 茅t茅 atteint par 35% et 28% des participants dans les groupes 50 mg et 28 mg. Notamment, 92% des r茅pondeurs 脿 la semaine 24 ont maintenu leur r茅ponse 脿 la semaine 96.
EFX a 茅t茅 g茅n茅ralement bien tol茅r茅, avec principalement des 茅v茅nements gastro-intestinaux l茅gers 脿 mod茅r茅s. Ces r茅sultats soutiennent le potentiel de l'EFX pour r茅duire la progression de la maladie chez les patients atteints de MASH.
Akero Therapeutics (Nasdaq: AKRO) ver枚ffentlichte in The Lancet die 96-Wochen-Ergebnisse der Phase-2b-Studie HARMONY, in der Efruxifermin (EFX) bei Patienten mit pr盲zirrotischer MASH gepr眉ft wurde. Die Studie zeigte eine signifikante Wirksamkeit, wobei 49% der Patienten, die 50 mg EFX erhielten, eine Verbesserung der Fibrose um mindestens ein Stadium erzielten, verglichen mit 19% unter Placebo.
Wesentliche Ergebnisse sind, dass 40% bzw. 37% der Patienten eine MASH-Heilung erreichten in den 28-mg- bzw. 50-mg-Gruppen, gegen眉ber 19% im Placebo. Der zusammengesetzte Endpunkt aus MASH-Heilung und Fibroseverbesserung wurde von 35% bzw. 28% der Teilnehmer in den 50-mg- bzw. 28-mg-Gruppen erreicht. Bemerkenswert ist, dass 92% der Woche-24-Ansprecher ihre Antwort in Woche 96 beibehielten.
EFX wurde insgesamt gut vertragen; haupts盲chlich leichte bis m盲脽ige gastrointestinale Ereignisse wurden berichtet. Die Ergebnisse st眉tzen das Potenzial von EFX, das Fortschreiten der Erkrankung bei MASH-Patienten zu verlangsamen.
- 49% of patients on 50mg EFX achieved fibrosis improvement vs 19% for placebo (p=0.0030)
- 92% of week 24 responders maintained their response at week 96
- 35% of 50mg EFX group achieved both MASH resolution and fibrosis improvement vs 7% placebo
- Sustained reductions in fibrosis and improvements in whole body metabolic health observed
- Higher treatment discontinuation rate in EFX groups compared to placebo
- Small reduction in bone mineral density observed after 96 weeks of treatment
- Gastrointestinal adverse events reported in treatment groups
Insights
Akero's 96-week HARMONY trial shows impressive fibrosis improvement with EFX in pre-cirrhotic MASH patients, approaching disease reversal in one-third of high-dose recipients.
The 96-week HARMONY trial results for efruxifermin (EFX) represent a significant advancement in MASH therapeutics. The trial demonstrated that 49% of patients receiving the 50mg dose achieved at least one stage of fibrosis improvement without worsening MASH, compared to just 19% for placebo (p=0.0030). This is particularly noteworthy as fibrosis improvement is the histological endpoint most strongly associated with reduced clinical outcomes in MASH.
The durability of response is especially compelling 鈥� 92% of week-24 responders maintained their response at week 96, while 63% of initial non-responders became responders with continued treatment. This suggests EFX may provide cumulative benefits with extended therapy, contrary to many treatments that plateau or lose efficacy over time.
The composite endpoint results are perhaps most impressive, with 35% of 50mg patients achieving both MASH resolution and fibrosis improvement versus just 7% for placebo (p=0.0013). This approaches disease reversal 鈥� a remarkable outcome in a condition historically resistant to pharmacological intervention.
The metabolic improvements beyond liver histology (reduced dyslipidemia, increased insulin sensitivity) reflect EFX's FGF21 analogue mechanism addressing the multisystem dysfunction underlying MASH. The consistent safety profile, primarily limited to gastrointestinal events, is reassuring, though the bone mineral density findings warrant monitoring in longer studies.
These results, combined with previously reported efficacy in MASH cirrhosis (SYMMETRY trial), position EFX as potentially the first agent capable of addressing the full spectrum of MASH severity, including those with advanced fibrosis at highest risk for liver-related complications.
Results support potential of efruxifermin (EFX) to reduce risk of fibrosis progression in聽patients with pre-cirrhotic (F2-F3) MASH
SOUTH SAN FRANCISCO, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced publication of 96-week results from the Phase 2b HARMONY trial in The Lancet.
The publication reports final results from HARMONY, a 96-week multicenter, randomized, double-blind, placebo-controlled trial that evaluated efruxifermin (EFX) in adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and moderate (F2) or advanced (F3) fibrosis. Continued treatment with EFX from 24 to 96 weeks resulted in more participants exhibiting improvements in fibrosis and MASH, such that there was near complete reversal of disease in almost one-third of participants treated with the 50mg dose of EFX. EFX-treated participants also exhibited improvements in markers of liver injury and whole-body metabolic health.
鈥淭he HARMONY results published in The Lancet provide encouraging evidence of EFX鈥檚 potential to reverse liver fibrosis and resolve steatohepatitis in patients with pre-cirrhotic MASH. The sustained and increased magnitude of response observed with longer treatment underscores the importance of therapies capable of longer-term use to address the underlying drivers of MASH,鈥� said Kitty Yale, chief development officer at Akero. 鈥淭hese results, combined with the exciting topline data from the 96-week SYMMETRY trial that demonstrated significant disease reversal in participants with cirrhosis due to MASH, paint an encouraging picture of the potential for EFX to transform patient outcomes, especially in those with a high fibrosis burden and greater risk of hepatic decompensation.鈥�
In the modified intent-to-treat (mITT) population at week 96,
The secondary endpoint of MASH resolution without fibrosis worsening was achieved by
Analysis of primary endpoint responders at week 24 and week 96 in the 50mg EFX group indicated that almost all (
EFX was generally well tolerated, with a safety profile consistent with previous trials. The most frequent adverse events were mild to moderate gastrointestinal events (e.g., diarrhea, nausea, increased appetite), which occurred at similar rates in the 28mg and 50mg groups. The rate of treatment discontinuation was similar for both doses but was greater than that for placebo. A small reduction in bone mineral density compared with placebo was observed after 96 weeks of EFX treatment. The relevance of this observation remains to be determined, as poor or declining bone health is common in adults with MASH.
The sustained reductions in fibrosis as well as MASH, the underlying disease driver, observed in this trial reflects an overall improvement in whole body metabolic health as evident by reduced dyslipidemia and increased insulin sensitivity. Furthermore, the magnitude of fibrosis improvement supports the potential of EFX to reduce disease progression and improve clinical outcomes, even in patients with high fibrosis burden. Confirmation of these potential benefits of EFX is being evaluated in the ongoing Phase 3 SYNCHRONY clinical trial program.
About EFX
Efruxifermin (EFX), Akero鈥檚 lead product candidate for MASH, is currently being evaluated in three ongoing Phase 3 studies. In multiple Phase 2 studies, EFX has been observed to reverse fibrosis (including compensated cirrhosis), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile. This holistic profile offers the potential to address the complex, multi-system disease state of all stages of MASH, including improvements in multiple risk factors linked to cardiovascular disease 鈥� the leading cause of death among MASH patients.聽Engineered to mimic the biological activity profile of native FGF21, EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.
About MASH
MASH is a serious form of MASLD that is estimated to affect 17 million Americans. MASH is characterized by excess fat accumulation in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer, and death. Approximately
risk of mortality. There are no approved treatments for cirrhosis due to MASH and MASH is the fastest growing cause of liver transplants and liver cancer in the US and Europe.
About HARMONY
HARMONY was a Phase 2b multicenter, randomized, double-blind, placebo-controlled trial in adult participants with biopsy-confirmed MASH and fibrosis stage 2 or 3. The trial enrolled and randomized 128 patients to once-weekly subcutaneous dosing of 28mg or 50mg EFX, or placebo for 96 weeks, 126 of whom received at least one dose of study drug and were included in the modified intent to treat (mITT) population. The primary efficacy endpoint was the proportion of participants with 鈮�1-stage fibrosis improvement without worsening of MASH. The trial continued for up to 96 weeks. Secondary endpoints included MASH resolution without fibrosis worsening, improvement in liver fibrosis, change from baseline in noninvasive markers of liver injury and fibrosis, glycemic control, lipoproteins, and body weight as well as safety and tolerability.
About Akero Therapeutics
Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH). Akero鈥檚 lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic (F2-F3 fibrosis) MASH, SYNCHRONY Outcomes in patients with compensated cirrhosis (F4) due to MASH, and SYNCHRONY AG真人官方-World in patients with MASH or MASLD (metabolic dysfunction-associated steatotic liver disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at聽 and follow us on聽 补苍诲听 for more information.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements'' within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding Akero鈥檚 business plans and objectives, including the ongoing Phase 3 SYNCHRONY clinical trial; and the potential therapeutic effects and anti-fibrotic activity of EFX, as well as the dosing, safety and tolerability of EFX. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking
statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Akero鈥檚 product candidate development activities and planned clinical trials; Akero鈥檚 ability to execute on its strategy; positive results from any of its clinical studies may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero鈥檚 ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors'' in Akero鈥檚 most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero鈥檚 other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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FAQ
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