Moleculin Biotech reports efficacy results from Phase 1B/2 trial of annamycin

Moleculin Biotech (MBRX) reported topline efficacy results from its completed U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases. The MB-107 trial was a multi-center, open-label, single-arm monotherapy study that in Phase 1B determined the Maximum Tolerable Dose and Recommended Phase 2 Dose and safety of Annamycin and in Phase 2 explored the efficacy of Annamycin as a single agent for the treatment of subjects with STS lung mets for which chemotherapy was considered appropriate. Clinical Benefit Rate was 59.4%, comprised of 18 subjects with stable disease and 1 subject with a partial response. Progression Free Survival & Overall Survival: Dose and regimen optimized subjects demonstrated PFS of ~4 months and OS of ~20 months; Overall Median PFS was 63 days, with a 95% Confidence Interval between 43 and 105 days; Median OS was 411 days, with a 95% CI between 241 and 583 days. In Phase 2 at 330 mg/m2: Median PFS was 105 days and OS for all-comers of 13.5 months exceeded typical results for 2nd line monotherapies; OS/PFS was higher for subjects with fewer prior therapies and receiving doses of Annamycin less than or equal to 330 mg/m2; Results suggest overall disease control was better at 330 mg/m2, but once combined with Phase 1B data OS and PFS was the same as overall. Subjects achieving a Partial Response or Stable Disease with greater than or equal to2 cycles also experienced higher OS/PFS, demonstrating that achieving CBR from Annamycin resulted in better outcomes. No cardiotoxicity demonstrated in all subject data as noted by an independent Expert.