The Phase II, multi-center, international randomized, double-blind, placebo-controlled study (Mpex 204) is expected to enroll 140 stable cystic fibrosis (CF) patients to evaluate the safety, tolerability and efficacy of three dosage regimens of MP-376 given once or twice daily for 28 days.
The doses of MP-376 to be used in this study are based on clinical and microbiological data from a previously completed Phase Ib study in which CF patients received 14 days of varying doses of MP-376.
Data from that study indicated that all doses were well tolerated and that patients experienced a reduction in bacterial counts of Pseudomonas aeruginosa in sputum. The primary efficacy endpoint to be assessed in the Phase II study will be microbiological (change in bacterial counts of Pseudomonas aeruginosa in sputum) over 28 days of dosing.
Additional endpoints and exploratory analyses will include the time to need for other inhaled or systemic antibiotics, changes in forced expiratory volume in one second (FEV1), and patient-reported outcomes.
Jeffery Loutit, chief medical officer of Mpex, said: “Based on the preclinical and early clinical work to date, we believe MP-376 has the potential to be an important new treatment option for CF patients.”