Results of the main study in patients with compensated cirrhosis due to NASH (F4) expected in fourth quarter of 2023
Results of the cohort D expansion to evaluate EFX in combination with GLP-1 therapy in patients with pre-cirrhotic NASH expected in second quarter of 2023
Following designation of EFX as a Breakthrough Therapy, a meeting has been scheduled for March 2023 with FDA to review results of the Phase 2b HARMONY study and to obtain feedback on a proposed Phase 3 clinical program
SOUTH SAN FRANCISCO, Calif., Dec. 21, 2022 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced that it has completed enrollment of the Phase 2b SYMMETRY main study evaluating efruxifermin (EFX) for the treatment of non-alcoholic steatohepatitis (NASH), in patients with compensated cirrhosis fibrosis stage 4 (F4). Enrollment is also complete for the expansion cohort, known as Cohort D, evaluating EFX in combination with GLP-1 therapy in patients with fibrosis stage 1-3 (F1-F3) and Type 2 Diabetes Mellitus (T2D).
“We are encouraged by the strength of our EFX data to date, including histology data from a Phase 2a proof-of-concept study in patients with cirrhosis due to NASH, and believe EFX has the potential to show favorable histology results in the SYMMETRY main study despite other investigational drugs having shown limited efficacy,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. “We look forward to reporting SYMMETRY data later next year as we evaluate EFX’s potential to slow or reverse progression of cirrhosis.”
The Phase 2b SYMMETRY main study is a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with compensated cirrhosis (F4, Child-Pugh class A). One hundred eighty-two patients have been randomized to receive once-weekly subcutaneous dosing of 28mg EFX, 50mg EFX, or placebo. The primary endpoint for the trial is fibrosis regression after 36 weeks treatment. Secondary measures include change from baseline in liver enzymes, liver fat, lipoproteins, glycemic control, and body weight at 36 weeks, as well as evaluation of safety and tolerability. To provide additional safety data from long-term follow up, patients will continue to receive EFX or placebo from 36 to 96 weeks.
The primary goal of the 12-week Cohort D expansion, in which 32 patients have been randomized, is to assess safety and tolerability of EFX compared to placebo when added to an existing GLP-1 receptor agonist in patients with T2D and F1-F3 liver fibrosis due to NASH. Demonstrating that EFX could accelerate NASH resolution and reversal of fibrosis among those patients already on GLP-1 therapy would help address an important unmet medical need.
Consistent with prior guidance, results from the Cohort D expansion cohort are expected in the second quarter of 2023, while results from the main study remain on track to be reported in the fourth quarter of 2023.
Following designation of EFX as a Breakthrough Therapy by the FDA, an End-of-Phase 2 meeting has been scheduled for March 2023 to review the HARMONY F2/3 data as well as the proposed Ph3 clinical program.
NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) that is estimated to affect 17 million Americans. NASH 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. There are no approved treatments for the condition and NASH is a leading cause of liver transplants in the US and Europe.
Efruxifermin (EFX), formerly known as AKR-001, is Akero’s lead product candidate for NASH, currently being evaluated in the ongoing Phase 2b HARMONY and SYMMETRY studies. EFX is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins. This holistic approach offers the potential to address the complex, multi-system disease state of NASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX offers convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.
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 non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero's lead product candidate, efruxifermin (EFX), is a differentiated, bivalent 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 is designed to offer convenient once-weekly subcutaneous dosing. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in two Phase 2b clinical trials: the HARMONY study in patients with pre-cirrhotic NASH (F2-F3 fibrosis), and the SYMMETRY study in patients with cirrhotic NASH (F4 fibrosis, compensated). EFX is also being evaluated in an expansion cohort of the SYMMETRY study, comparing the safety and tolerability of EFX to placebo when added to an existing GLP-1 receptor agonist in patients with pre-cirrhotic NASH (F1-F3 fibrosis) and Type 2 diabetes. Akero is headquartered in South San Francisco. Visit us at www.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 efruxifermin (EFX), the therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; and upcoming milestones, including the results, and expected timing to report such results of Akero’s Phase 2b SYMMETRY study and the Cohort D expansion cohort; the potential benefits resulting from the Breakthrough Therapy Designation of EFX and related implications; and the timing and expectations around regulatory interactions, including planned meetings with the FDA to discuss the development 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: risks related to the impact of COVID-19 on Akero’s ongoing and future operations, including potential negative impacts on Akero’s employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; 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.