Akero Therapeutics (AKRO) Jefferies London Healthcare Conference 2024 summary

Pipeline and clinical development status

• Phase 3 programs underway for F2, F3, and F4 NASH/MASH, with non-invasive and histology-based studies enrolling since late 2023 and 2024.

• First patient enrolled in phase 3 cirrhotic outcome study in Q3 2024.

• SYNCHRONY Real-World (non-invasive) data expected in 2026; F2-F3 histology study readout in H1 2027.

Key study results and expectations

• SYMMETRY phase 2b in F4 cirrhosis showed 24% fibrosis improvement at 50mg vs. 14% placebo at 9 months, best in field but missed statistical significance.

• Two-year (96-week) biopsy results for SYMMETRY expected February 2025, with anticipation of broader and deeper response based on prior F2-F3 data.

• F2-F3 HARMONY study showed 40% vs. 20% improvement at 24 weeks, increasing to 75% vs. 25% at 96 weeks, with strong statistical significance.

• Phase 3 cirrhosis study is well powered with over 1,100 patients, aiming for robust statistical significance on primary endpoints.

Market and competitive landscape

• NASH/MASH market is growing, with recent strong launches (e.g., Madrigal's $62M in Q2) and multiple FGF21 agents showing similar efficacy.

• FGF21 competitors include Boston Pharmaceuticals and Novo, with similar effect sizes and varying dosing regimens (weekly vs. monthly).

• GLP-1s are widely used but may not address F4 cirrhosis; combination therapy with EFX and GLP-1s shows promising synergistic effects.

• Despite market growth, major M&A activity in NASH has yet to materialize, but positive data could catalyze transactions.