Akero strengthens MASH drug’s case with new study data

Dive Brief:

• The effects of an experimental medicine for a common liver disease strengthened with time in a clinical trial, giving the drug’s developer, Akero Therapeutics, a chance to rebound from a setback last year.
• Akero previously said the trial hit its main goal. After six months of treatment, 39% of patients with metabolic dysfunction associated steatohepatitis on a low dose of the drug and 41% on a high dose had a meaningful reduction in liver scarring and no worsening of their disease, versus 20% of placebo recipients. New results disclosed Monday show that 75% of those on a high dose and 46% on a low dose hit that mark after two years, compared to 24% of placebo patients.
• The most common side effects associated with treatment were mild-to-moderate cases of diarrhea, nausea and increased appetite. The 15 serious adverse events reported were “generally balanced across dose groups,” though Akero didn’t provide specifics. Three patients on the high dose stopped treatment. Shares were up around 27% early Monday morning.

Dive Insight:

After a series of drugmaker setbacks, competition developing medicines for metabolic dysfunction associated steatohepatitis, or MASH, is heating up again.

The first drug for the condition, Madrigal Pharmaceuticals’ resmetirom, could be approved by the Food and Drug Administration this month. Akero is one of several others, including 89bio and Viking Therapeutics, following closely behind. Popular weight-loss medicines are being tested against MASH as well, and two have already shown promise.

Akero believes its drug, called efruxifermin, has a chance to stand out. Efruxifermin works differently than Madrigal’s medicine, mimicking the activity of a protein that regulates the metabolism of lipids and carbohydrates. By doing so, it’s supposed to reduce the toxic buildup of liver fat in MASH patients, as well as improve blood sugar control.

In an email to BioPharma Dive, Chief Operating Officer Jonathan Young wrote that resmetirom’s impact on fibrosis is “similar to the ‘modest efficacy’” the Food and Drug Administration described when reviewing Intercept Pharmaceutical’s obeticholic acid, a medicine the agency rejected twice.

“Based on today’s data, we believe efruxifermin has the potential to deliver substantially higher rates of fibrosis improvement” than resmetirom in people who don’t yet have cirrhosis, Young wrote.

Chief Scientific Officer Tim Rolph added that the obesity drugs in testing don’t directly target the liver, which, at least so far, “translates into little beneficial impact on fibrosis.” The company anticipates efruxifermin, if approved, would be used on its own as well as alongside obesity drugs to increase effects on liver scarring, he wrote.

Yet Akero has reported mixed results. The drug succeeded in the mid-stage study it updated on Monday, which tested efruxifermin in people with stage 2 or 3 fibrosis. But company shares lost more than half their value in October, after the drug missed its main mark in another trial in patients with more advanced disease.

The updated results were being closely watched by analysts as an indicator of the drug’s prospects in a pair of ongoing Phase 3 trials. Jefferies analyst Michael Yee, for one, was looking to see if efruxifermin could widen its separation from placebo on symptoms and sustain its difference on fibrosis. Such an outcome “should improve confidence” in that study, Yee wrote last month.

Young, for his part, noted that “all the key measures” in the failed study were moving “in the right direction” in a particularly tough-to-treat patient group. Monday’s results are “broadly consistent with the totality of data generated to date,” he wrote.

“This is the highest fibrosis delta by any drug and above investor expectations,” wrote Jefferies analyst Yee, in a Monday note to clients. The results “support what we see as best-in-class and best-in-disease therapeutic” for MASH.

Minor changes in bone density were more commonly observed in people who received Akero’s drug. But Yee highlighted how those changes weren’t “much different from what is expected” in the study population, and the overall risks and benefits favor efruxifermin.

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