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Barron's Akero Therapeutics Bats Back Challenge From Lilly in Emerging Liver-Drug Market

Less than a month after Eli Lilly released trial results that seemed to kick the legs out from under the biotech companies racing to develop treatments for the serious liver condition now known as MASH, Akero Therapeutics is roaring back with data that analysts say could be the best yet presented.

Liver fibrosis, or scarring, is classified in stages, with stage four signifying chronic liver failure, or cirrhosis. Akero said that in a mid-stage study of MASH patients, 75% of those on a high dose of its drug efruxifermin saw an improvement in liber fibrosis of at least one stage. That compares with 24% of patients who received a placebo.

Akero’s data suggests that its drug can actually reduce the serious effects of MASH, potentially more effectively than any other drugs tested so far.

In early February, Lilly rocked the sector with MASH data of its own, announcing that after 52 weeks, 74% of MASH patients on its Type 2 diabetes and obesity drug tirzepatide, which is sold under the brand names Mounjaro and Zepbound, had no MASH, or liver inflammation, and no worsening of fibrosis, compared with 13% of patients on a placebo.

That tirzepatide MASH data scared biotech investors, sending Akero shares down 12% the day it was announced. The fear was that Lilly’s drug, already all but destined to be a record-shattering blockbuster as a treatment for obesity and Type 2 diabetes, would wipe out demand for MASH-specific treatments under development by competitors.

The Lilly announcement, however, didn’t specify the degree to which tirzepatide had improved fibrosis in patients. The company said that there was a “clinically meaningful” decrease in fibrosis in its study, but didn’t quantify it.

Akero’s drug’s decrease in fibrosis announced Monday, meanwhile, blew past expectations, and past data from the handful of peers that have released competing results. The Phase 2B data from Akero, Jefferies analyst Michael Yee wrote early Monday, “support what we see as best-in-class and best-in-disease therapeutic.”

Akero shares opened at $35.51 on Monday morning, up 28% from their previous close of $27.81. On Feb, 6, the day Lilly released its tirzepatide MASH data, the stock fell from a previous close of $20.24 to $17.76. 

Akero shares pulled back slightly as the morning progressed on Monday, after the company released more detailed safety data during a conference call. There were 15 serious adverse events in the 126-patient trial, including two that the investigators considered to be drug-related.

In a note before the call, Cantor Fitzgerald analyst Prakhar Agrawal said that the results wash away worries that drugs like Lilly’s tirzepatide will undermine the commercial opportunity for Akero’s drugs, and drugs like it. “The impact of GLP1 combinations on the MASH commercial opportunity for anti-fibrotic drugs like EFX doesn’t even matter now,” Agrawal wrote.