Press Release Details

As reported previously, the addition of EFX to GLP-1 receptor agonist therapy had a safety and tolerability profile comparable to that of EFX alone and led to statistically significant improvements in non-invasive markers of liver injury and fibrosis and of metabolic health

Results indicate potential of EFX to improve resolution of steatohepatitis and fibrosis for patients with MASH and type 2 diabetes already taking a GLP-1 receptor agonist

SOUTH SAN FRANCISCO, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease, today announced publication of results in Clinical Gastroenterology and Hepatology from an expansion cohort (Cohort D, N=31) of the Phase 2b SYMMETRY study.

The publication, available online, reports results of the 12-week study to assess safety and tolerability of efruxifermin (EFX) compared to placebo when added to a stable dose of GLP-1 receptor agonist (GLP-1RA) in patients with Type 2 diabetes (T2D) and F1-F3 liver fibrosis due to metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH.

Tolerability of EFX on top of GLP-1RA (N=21 patients) was generally comparable to GLP-1RA alone (placebo, N=10). The most frequent adverse events for EFX-treated patients were grade 1 or 2 gastrointestinal events (diarrhea, nausea, and increased appetite). One patient treated with EFX discontinued due to nausea and one EFX-treated patient withdrew consent prior to Week 12. There were no drug-related serious adverse events. The overall tolerability profile was similar to that observed in Akero’s prior BALANCED and HARMONY studies in patients with MASH (F1-F3). Patients treated with EFX plus GLP-1RA showed a similar mean weight loss from baseline relative to patients treated with GLP-1RA alone.

Non-invasive markers of liver health showed clinically meaningful improvements following treatment for 12 weeks with EFX plus GLP-1RA compared to GLP-1RA alone (placebo). Notably, liver fat was reduced from baseline by 65% for EFX on top of GLP-1RA compared to a 10% relative reduction for GLP-1RA alone, with levels normalized (5% absolute) in almost 90% of patients receiving EFX plus GLP-1RA compared to 10% of those receiving GLP-1RA alone. In addition, patients treated with EFX plus GLP-1RA (N=21) had greater improvements in non-invasive markers of liver injury (ALT and AST) and fibrosis (Pro-C3 and ELF), than those receiving GLP-1RA alone (N=10). Markers of glycemic control and lipid metabolism were also improved more with EFX plus GLP-1RA than GLP-1RA alone, reflecting the complementary insulin-sensitizing action of EFX when combined with an insulin secretagogue such as GLP-1RA.

“We believe these data indicate that EFX could be an important treatment option for patients with MASH who are already receiving GLP-1RA for T2D or obesity,” said Kitty Yale, chief development officer of Akero. “We look forward to continuing the development and assessment of EFX in our Phase 3 SYNCHRONY Histology and SYNCHRONY Real-World studies which are currently enrolling patients including those on stable GLP-1RA therapy.”

About Efruxifermin
Efruxifermin (EFX), Akero’s lead product candidate for MASH, is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX appears to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipids. This holistic approach offers the potential to address the complex, multi-system disease state of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in MASH patients. 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 more than 17 million Americans. MASH is characterized by an excessive accumulation of fat 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 eventually death. Approximately 20% of patients with MASH will progress to cirrhosis, which has a higher risk of mortality. There are no approved treatments for the condition and MASH is the fastest growing cause of liver transplants and liver cancer in the US and Europe.

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 MASH, a disease without any approved therapies. Akero's lead product candidate, EFX, is currently being evaluated in two ongoing Phase 3 clinical trials: the SYNCHRONY Histology study in patients with pre-cirrhotic MASH (F2-F3 fibrosis) and the SYNCHRONY Real-World study in patients with MASH or MASLD. A third clinical trial, the SYNCHRONY Outcomes study in patients with cirrhosis due to MASH, is expected to be initiated in the first half of 2024. 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 cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and Twitter 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’s business plans and objectives, including future plans or expectations for EFX, the therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; the timing and enrollment of Akero’s Phase 3 SYNCHRONY program; and upcoming milestones. 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’s product candidate development activities and planned clinical trials; Akero’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero’s ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero’s 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’s 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.

Investor Contact:
Christina Tartaglia
212.362.1200
IR@akerotx.com

Media Contact:
Sarah O’Connell
732.456.0092
soconnell@vergescientific.com