Shares of Akero Therapeutics AKRO skyrocketed 105.7% in a week after the company announced initial positive top line 96-week data from a mid-stage study of its lead product candidate, efruxifermin (EFX), for liver disease. The phase IIb SYMMETRY study evaluated two doses of EFX (28mg and 50mg) compared with a placebo in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH).
Per the data readout, in patients with both baseline and week 96 biopsies, 39% of those receiving 50mg EFX experienced cirrhosis reversal without MASH worsening, compared to 15% in the placebo group.
In the Intent-to-Treat analysis, which considered missing week 96 biopsies as treatment failures, 29% of the 50mg EFX group achieved cirrhosis reversal without MASH worsening, compared to about 12% in the placebo group.
The SYMMETRY study highlights the advantages of extended EFX treatment for patients with compensated cirrhosis, as evidenced by more than a twofold increase in effect size in the 50mg group, rising from 10% at week 36 to 24% at week 96.
In the past three months, Akero’s shares rallied 67.7% against the industry’s 6.8% fall.
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More on AKRO’s MASH Program for EFX
Akero further reported that among patients in the SYMMETRY study who were not on GLP-1 therapy at baseline (n=97) with week 96 biopsies, 45% receiving 50mg EFX experienced cirrhosis reversal without MASH worsening, compared to 17% in the placebo group. This suggests the observed cirrhosis reversal was independent of GLP-1 therapy.
In the mid-stage study, EFX was generally well tolerated, with no deaths in the EFX group and one in the placebo group due to pneumonia. No serious adverse events were linked to the study drug. The most common side effects in both EFX groups were mild to moderate gastrointestinal issues that were temporary.
Akero is currently evaluating the safety and tolerability of EFX in a phase III SYNCHRONY program, comprising three ongoing studies, to support regulatory filings for the candidate to treat both pre-cirrhotic MASH (F2-F3) and F4 due to MASH.
AKRO’s Success Boosted ETNB’s Stock Price
Interestingly, the positive results from Akero’s compensated cirrhotic MASH study also boosted the shares of rival company 89bio ETNB, which surged 33.5% in a week. ETNB is developing a similar treatment for MASH.
89Bio is developing its only pipeline candidate, pegozafermin, an investigational FGF21 analog, to treat MASH and another cardiometabolic indication. In 2024, ETNB initiated dosing in its phase III ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis studies in F2-F3 MASH patients with fibrosis and F4 MASH patients, respectively. Both MASH studies are currently enrolling patients globally.
Furthermore, 89Bio has also received feedback from the FDA and European Medicines Agency on clinical and CMC requirements for pegozafermin's marketing authorization for both indications. The company remains on track for potential regulatory filings, subject to positive clinical results.
Akero Therapeutics, Inc. Price and Consensus
Akero Therapeutics, Inc. Price and Consensus
Akero Therapeutics, Inc. price-consensus-chart | Akero Therapeutics, Inc. Quote
Other Players in the Market for MASH Treatments
Madrigal Pharmaceuticals MDGL currently markets Rezdiffra (resmetirom), as the first and only FDA-approved therapy for the treatment of adult patients with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), in conjunction with diet and exercise. MASH is also known as nonalcoholic steatohepatitis.
A regulatory application seeking the approval of MDGL’s resmetirom for the same indication is also currently under review in the EU. Madrigal expects a final decision in mid-2025.
Cirrhosis caused by MASH is a severe, life-threatening condition that significantly increases the risk of liver failure, cancer and death. Approximately 3 million Americans are expected to have MASH-related cirrhosis by 2030, making it the fastest-growing driver of liver transplants and liver cancer in both the United States and the EU. Thus, it represents a lucrative market opportunity where Madrigal enjoys the first-mover advantage.
A prominent player in the obesity market, Novo Nordisk NVO, is also evaluating its blockbuster GLP-1 therapy, semaglutide, for MASH. In late 2024, Novo Nordisk reported positive results from part 1 of its pivotal phase III ESSENCE study in 1,200 adults with MASH and moderate to advanced liver fibrosis. Per the data readout, the study achieved its primary endpoints by demonstrating a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo.
Novo Nordisk is currently gearing up to file for regulatory approvals of semaglutide 2.4 mg to treat MASH in the United States and EU in the first half of 2025. NVO’s semaglutide is currently marketed under the brand names Rybelsus oral tablet and Ozempic for type II diabetes and Wegovy injection for chronic weight management.
AKRO’s Zacks Rank
Akero currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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