All AKR-001 Dose Groups Met Week 12 Efficacy Endpoints in NASH Phase 2a BALANCED Study
All AKR-001 Dose Groups Met Week 12 Efficacy Endpoints in NASH Phase 2a BALANCED Study All AKR-001 dose groups met the primary endpoint, with statistically significant absolute reductions in liver fat of 12-14% |
[31-March-2020] |
SAN FRANCISCO, March 31, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (Nasdaq: AKRO) today announced that all three AKR-001 dose groups in the BALANCED study met the primary endpoint of absolute change from baseline in liver fat as measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) – at week 12. Results for the primary endpoint as well as other week 12 efficacy endpoints are summarized in the table below.
"The magnitude and rate of improvements in liver fat content and ALT observed over 12 weeks in the BALANCED study are among the most robust NASH clinical trial results reported to date," said Stephen Harrison, M.D., medical director of Pinnacle Clinical Research. "AKR-001 is emerging as one of the most promising drug candidates in development for this serious disease." The BALANCED study is an ongoing randomized, double-blind, placebo-controlled study in NASH patients. While the study remains blinded, the tolerability profile appears consistent with results from previous clinical trials evaluating AKR-001 in patients with Type 2 diabetes. The adverse events observed most frequently in prior trials were mild/moderate gastrointestinal events and injection site reactions. After 12 weeks of treatment, patients who have achieved at least a 30% relative reduction in liver fat are eligible for an end-of-study biopsy. Across the AKR-001 dose groups, 75-85% of patients are eligible for biopsies. As of March 30, 2020, 25 end-of-study biopsies have been collected from a total of 50 eligible patients. We expect to report the top-line safety/tolerability, laboratory measures and paired biopsy data from the BALANCED study in the second quarter of this year. The extent to which the COVID-19 pandemic will interfere with collection of the remaining biopsies and data from other scheduled clinical visits, including the safety follow-up visit at week 20, is unclear. We are delaying the planned initiation of the BALANCED study cohort C in NASH patients who have compensated cirrhosis (F4), Child-Pugh Class A. "We are encouraged by these results, which support continued development of AKR-001 for treatment of NASH," said Andrew Cheng, M.D., Ph.D., president and CEO of Akero. "AKR-001 has the potential to provide NASH patients with an important treatment option when there are still no approved therapies. We look forward to the full data set with anticipation and are preparing for the next steps in AKR-001's development." Conference Call / Webcast Details About NASH About the BALANCED Study About AKR-001 About Akero Therapeutics Forward Looking Statements 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, which has been labelled a pandemic by the World Health Organization, 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. View original content to download multimedia:http://www.prnewswire.com/news-releases/all-akr-001-dose-groups-met-week-12-efficacy-endpoints-in-nash-phase-2a-balanced-study-301032199.html SOURCE Akero Therapeutics, Inc. | |||||||||||||||||||||||||||||||||||||||||||
Company Codes: NASDAQ-NMS:AKRO |
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