Galmed Pharmaceuticals Ltd. Q3 FY2021 earnings call

Allen Baharaff introduced the call, mentioning the Phase 3 ARMOR study, the presence of Chief Scientific Officer Dr. Liat Hayardeny and Chief Financial Officer Yohai Stenzler, and invited Professor Vlad Ratziu to present results from the open label part of the Phase 3 ARMOR study. Professor Ratziu discussed the innovative open label study within the Phase 3 trial, detailing baseline characteristics of patients, preliminary results showing 60% of 20 patients had fibrosis reduction by 1 stage or more, and positive biomarker results including reductions in aminotransferases, FIB-4, and PRO-C3. These results reinforce the drug's ability to induce histological improvement and fibrosis reversal, supporting the higher dose use in the Phase 3 ARMOR study.

Plan to reinitiate the double-blind part of the ARMOR study in the second half of 2022, expecting a shorter design based on improved effect size. Continuing manufacturing of Aramchol meglumine clinical batches for a bioequivalence study and subsequent double-blind study. Anticipate releasing further data around EASL.

Q: Any patients in the cohorts receiving other therapies like vitamin E, pioglitazone?

A: Patients are non-responders to such therapies; lifestyle changes are actively reinforced but not systematically implemented.

Q: Time to onset of effects?

A: Understanding dynamics of antifibrotic potency, importance of multiple time points to assess kinetics of response and individual variability.

Q: Comparison to other NASH drugs?

A: Aramchol shows higher fibrosis reduction than historical placebo rates and some other drugs, though Phase 3 trial needed for confirmation.

Q: Double-blind study enrollment?

A: Plan to reinitiate in second half of 2022, working on manufacturing and bioequivalence study.

Q: Diversity of patient population?

A: Population for double-blind part includes US, Europe, Latin America, Korea, China, Australia, using leading sites.

Q: Phase 1 data on Amilo-5MER?

A: Finalizing data, planning Phase 1b/2a study early next year.

Q: ALT reduction correlation?

A: No specific correlations run apart from presented data.