Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported second quarter financial results for the period ending June 30, 2024 and provided business updates.
“The second quarter of 2024 brought important progress for EFX with the initiation of the Phase 3 SYNCHRONY Outcomes trial and appointment of a chief technical officer,” said Andrew Cheng, president and CEO. “Initiation of the final planned trial in the Phase 3 SYNCHRONY program and expansion of our leadership team strengthen Akero’s position to advance our EFX program, bringing us closer to providing this potentially transformative therapy to patients in need.”
Third Phase 3 Clinical Trial Initiated In SYNCHRONY Program
- Akero’s global Phase 3 SYNCHRONY clinical trial program consists of three ongoing global, randomized, placebo-controlled trials to support marketing applications for treatment of compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) and pre-cirrhotic MASH.
- SYNCHRONY Outcomes is a two-cohort trial recruiting patients with compensated cirrhosis (F4) due to MASH to receive weekly injections of EFX 50mg or placebo. The primary histology endpoint (Cohort 1 only) is fibrosis regression without worsening of MASH after 96 weeks of treatment based on histology. Patients will continue treatment as randomized to be evaluated for the primary outcomes endpoint measured as time to first occurrence of any of the pre-defined, adjudicated events across both Cohort 1 and 2.
- SYNCHRONY Histology is enrolling patients with pre-cirrhotic MASH, fibrosis stage 2 or 3 (F2-F3) to receive weekly injections of EFX 28mg, EFX 50mg, or placebo. The primary endpoint, to support an application for accelerated approval, is the proportion of patients experiencing ≥ 1-stage fibrosis improvement AND resolution of NASH/MASH after 52 weeks of treatment. After 52 weeks, patients will continue treatment as randomized in SYNCHRONY Histology to be followed for long-term clinical outcomes.
- SYNCHRONY Real-World is enrolling patients with MASH or MASLD to receive weekly injections of EFX 50mg or placebo. The primary endpoint of safety and tolerability will be assessed after 52 weeks of treatment.
- In all EFX Phase 3 studies, patients are using the LyoJect 3S dual chamber syringe, a pre-filled device designed for self-administration and intended for commercial use in the event EFX is approved for marketing.
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