Date: 2016-03-07
Type of information: Grant
Company: Cempra (USA - NC)
Investors: Department of Health and Human Services (USA)
Amount: $25.5 million
Funding type: grant
Planned used: These funding will be used to finance a Phase 2/3 clinical study of solithromycin. Cempra is responsible for an additional designated portion of the cost of the planned Phase 2/3 study. Pediatric patients from age 2 months to 17 years with community-acquired bacterial pneumonia (CABP) who are enrolled in the study may receive intravenous, oral suspension or oral capsule formulations of solithromycin or a comparator treatment. The planned enrollment of 400 patients for the Phase 2/3 study is expected to begin during the first half of 2016, with full enrollment expected during the first half of 2018. The trial will be conducted at 60 centers worldwide. Patients will be randomized 3:1 to receive solithromycin (n~300) as an oral, IV or suspension formulation, or a comparator drug (n~100). The primary endpoint will be safety and the secondary endpoints will be efficacy and pharmacokinetics in the pediatric population. Patients will receive solithromycin for 5 to 7 days and the dose will be based on the age and weight of the patient. The duration of treatment will be up to the treating physician. Comparator treatments include amoxicillin, amoxicillin-clavulanic acid, ampicillin, azithromycin, ceftriaxone and erythromycin. Primary safety endpoints for the Phase 2/3 study will be the proportion of subjects experiencing an adverse event (AE) and the proportion of subjects discontinuing study drug due to a related AE. The secondary efficacy endpoint is defined as clinical improvement on the last day of treatment (end of treatment response), and additional efficacy endpoints are defined as early clinical response at days 2-4 and clinical success (cure) at the short-term follow-up visit which is 10 days (+/- 4 days) after the last dose of treatment.
Others:
Therapeutic area: Infectious diseases
