Will Akero’s (AKRO) NASH Data Delight Investors?

Akero Therapeutics Inc. (AKRO), which completed its IPO last June, has since gained more than 30 percent and trades around $24.

Akero Therapeutics is a clinical-stage biotechnology company developing therapies for metabolic diseases like nonalcoholic steatohepatitis (NASH).

Pipeline

The Company’s sole product candidate is AKR-001, a potential treatment for patients with NASH, which is under a phase IIa study, dubbed BALANCED.

The NASH Study

The phase IIa BALANCED study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial evaluating AKR-001 in biopsy-confirmed patients with NASH.

The trial involves 80 patients who are randomized to receive weekly subcutaneous doses of AKR-001 or placebo for up to 16 weeks, with safety and tolerability followed through week 20.

The primary efficacy endpoint for the study is absolute change from baseline in hepatic fat fraction measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) at week 12. Secondary measures include the change from baseline in ALT (alanine transaminase, a liver enzyme) at 12 weeks, the number of patients who had a decrease of more than 2 points in the NAFLD activity score at 24 weeks and safety and tolerability measures.

Near-term Catalyst

Topline results from the BALANCED study are due in the first quarter of 2020, with full data readout anticipated in the second quarter of 2020.

Market Potential

An estimated 16 million Americans are said to have NASH, and there is no approved drug for this yet. The global addressable pharmaceutical market could reach $35-40 billion by 2025, according to analysts.

Cash Position

Akero’s cash and cash equivalents at September 30, 2019 were $147.8 million.

AKRO, which went public on the Nasdaq Global Select Market on June 20, 2019, has thus far hit a low of $16.06 and a high of $34.00.

The stock closed Friday’s (Mar.6, 2020) trading at $24.41, up 2.48%.

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