Akero Presents Additional Positive Data from Phase 2a BALANCED Study Demonstrating Potential of Efruxifermin as a Foundational NASH Monotherapy
Akero Therapeutics (Nasdaq: AKRO) presented new data from its Phase 2a BALANCED study at The Liver Meeting®, highlighting efruxifermin (EFX) as a promising monotherapy for non-alcoholic steatohepatitis (NASH). The study revealed significant reductions in liver fat, with 100% of patients in the 50mg EFX group achieving over 50% relative reduction. Additionally, 50% of patients with fibrosis stage F2 or F3 experienced a two-stage improvement. EFX, showing positive effects on glycemic control, is expected to enter a Phase 2b/3 trial in 2021, supported by EMA’s PRIME designation.
- 100% of patients in the 50mg EFX group achieved over 50% relative reduction in liver fat.
- 50% of treated patients with fibrosis stage F2 or F3 showed a two-stage improvement.
- Significant reductions in HbA1c observed, including a 0.9% decrease in patients with NASH and Type 2 diabetes at the 70mg dose.
- Projected initiation of Phase 2b/3 trial in 2021 based on positive results.
- None.
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Akero Therapeutics, Inc. (Nasdaq: AKRO) today announced the presentation of additional data analysis from the Phase 2a BALANCED study at the Presidential Oral Plenary Session at The Liver Meeting®. The data continue to demonstrate the potential of efruxifermin (EFX) as a foundational monotherapy for patients with non-alcoholic steatohepatitis (NASH).
Overall, the data show large magnitudes of reduction in liver fat across all EFX dose groups with
Among all EFX-treated patients who were fibrosis stage F2 or F3 at baseline (n=22),
Additional analysis of the BALANCED data showed substantial improvement in glycemic control for patients with both NASH and Type 2 diabetes, a group that comprises about half of all NASH patients. The company previously reported mean absolute reductions in HbA1c among all study participants of
“Additional analyses from the BALANCED study, including the proportion of subjects with at least 50 and
EFX has received European Medicines Agency Priority Medicines (PRIME) designation as a treatment for NASH. Akero plans to begin a Phase 2b/3 adaptive clinical trial in biopsy confirmed NASH patients in the first half of 2021. The company will be using 28mg and 50mg doses for that trial.
Akero previously reported data from the BALANCED study demonstrating that each of the 28, 50 and 70mg EFX dose groups met the primary endpoint compared to placebo, with absolute reductions of
Prior Reporting of secondary and exploratory endpoints revealed that of the 40 EFX treatment responders who had end-of-treatment biopsies,
About NASH
NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. 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. NASH is a leading cause of liver transplants in the US and Europe.
About the BALANCED Study
The Phase 2a BALANCED study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed adult patients with NASH. The main study enrolled a total of 80 patients. Participants were randomized to receive weekly subcutaneous doses of efruxifermin (EFX), formerly known as AKR-001, or placebo for up to 16 weeks, with safety and tolerability followed through week 20. The primary efficacy endpoint for the study is absolute change from baseline in hepatic fat fraction measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) at week 12. Secondary measures include change from baseline in ALT at 12 weeks, the number of patients who had a decrease of ≥2 points in the NAFLD activity score (NAS) at 24 weeks and safety and tolerability measures.
About Efruxifermin
Efruxifermin (EFX), formerly known as AKR-001, is Akero’s lead product candidate for NASH, currently being evaluated in the ongoing Phase 2a BALANCED study. 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 is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company’s lead product candidate, Efruxifermin (EFX), formerly known as AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.
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. Such statements include, but are not limited to, statements regarding: Akero's guidance regarding its business plans and objectives for EFX, including the therapeutic potential and clinical benefits thereof, as well as the safety and tolerability of EFX and future clinical development plans; Akero's Phase 2a BALANCED clinical trial, including its results and Akero’s analysis of such results; Akero’s design, implementation and expected timing of the Phase 2b/3 trial; the potential benefits conferred by the EMA on Akero’s PRIME designation; and the potential impact of COVID-19 on patient retention, strategy, future operations and clinical trials.
Any forward-looking statements in this statement 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 public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19, including potential negative impacts on Akero's employees, manufacturers, supply chain and production as well as on global economies and financial markets; the company'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 risks related to the competitive landscape. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Akero's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the company's 2019 Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Akero's other filings 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.
