By The Life Science Report

Source: Streetwise Reports   07/01/2020

Akero Therapeutics shares traded 28% higher and established a new 52-week high after the company reported that it recorded positive histological data across all Efruxifermin dosage groups in its Phase 2a BALANCED Study in NASH patients.

Clinical-stage biotechnology company Akero Therapeutics Inc. (AKRO:NASDAQ), which develops and commercializes treatments for serious metabolic diseases, yesterday announced “results of a 16-week analysis of secondary and exploratory endpoints in its Phase 2a BALANCED study of efruxifermin (EFX), formerly known as AKR-001, in patients with nonalcoholic steatohepatitis (NASH).”

The firm highlighted that “of the 40 treatment responders who had end-of-treatment biopsies, it observed that 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score and 28% achieved at least a two-stage improvement in fibrosis.”

Stephen Harrison, M.D., medical director of Pinnacle Clinical Research, remarked, “These substantial improvements observed in multiple measures of liver health, particularly the one- and two-stage improvements in fibrosis, are extremely encouraging and among the strongest biopsy results reported in NASH to date…I believe Efruxifermin continues to set itself apart as one of the most promising drug candidates in NASH, with impressive histology results after just 16 weeks of treatment.”

Akero Therapeutics’ President and CEO Andrew Cheng, M.D., Ph.D., commented, “We believe the BALANCED study data, which exceeded our expectations, demonstrate the strong potential of efruxifermin to be a foundational monotherapy for the treatment of NASH…We look forward to the continued development of efruxifermin and are working diligently to deliver this potentially leading treatment to patients. We are extremely grateful to all of our investigators and study patients, particularly given that this study cohort was completed amidst the COVID-19 pandemic.”

The company advised that the BALANCED study is an ongoing clinical trial in NASH patients and that the firm previously reported that several EFX dose groups in the study had met the primary endpoint compared to placebo.

The Phase 2a BALANCED study enrolled a total of 80 patients and was described as “a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed adult patients with NASH.”

The firm explained that NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) that is closely linked to obesity and diabetes epidemics observed worldwide. The company stated that NASH affects around 17 million Americans and is a leading cause of liver transplants both in the US and Europe.

The company additionally listed that Efruxifermin (EFX) is its lead product candidate for NASH and “it is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins.”

Akero Therapeutics is headquartered in South San Francisco, Calif., and described it business as “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.”

Akero Therapeutics started the trading day with a market capitalization of around $714.6 million with approximately 28.67 million shares outstanding. AKRO shares opened 40% higher today at $35.10 (+$10.18, +40.85%) over yesterday’s $24.92 closing price and reached a new 52-week high price this morning of $35.30. The stock has traded today between $31.12 and $35.30 per share and is currently trading at $32.00 (+$7.08, +28.41%).

Sign up for our FREE newsletter at: www.streetwisereports.com/get-news

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: AKRO:NASDAQ,
)