Moleculin Biotech completes End of Phase 2 meeting with FDA for Annamycin

Moleculin Biotech announced the completion of its End of Phase 2, or EOP2, meeting with the FDA for its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy, or MB-106. The Company expects to report outcomes from the EOP2 meeting upon receipt of official minutes from FDA which is expected by the end of Q3. The EOP2 meeting was supported by second-line treatment results from the Company’s ongoing MB-106 clinical trial. As recently reported on June 14, 2024, a total of 22 subjects have been enrolled, 20 of whom have completed efficacy evaluations with 9 subjects, or 45%, achieving a composite complete remission, consisting of 8, or 40%, subjects with complete remission, or CR, and one subject with complete remission with an incomplete recovery of peripheral blood counts, or CRi, following treatment with AnnAraC. Efficacy outcomes for 2 additional subjects (enrolled and treated) are pending. Of the 10 ITT subjects for whom AnnAraC was administered in the 2nd line setting, 5 achieved a CR, or 50%, and 6 achieved a CRc, or 60%. Of the 13 subjects in the ITT evaluable population that were 1st or 2nd line treatment, 7 achieved a CR, or 54%, and 8 achieved a CRc, or 62%. The mDOR for the 9 subjects who achieved a CRc is approximately 7 months and climbing.