Clinical-stage pharmaceutical firm Cempra has obtained fast track designation from the US Food and Drug Administration (FDA) for solithromycin intravenous (IV) and capsules to treat community acquired bacterial pneumonia (CABP).
Currently, the company is carrying out phase three trials for solithromycin to treat CABP and plans to submit a new drug application (NDA) in 2016.
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The firm also designed a phase three trial with solithromycin in uncomplicated gonorrhoea, which is expected to complete patient enrolment by the end of this year.
Additional clinical trials with solithromycin include a phase II trial in chronic obstructive pulmonary disease (COPD), a phase two trial in nonalcoholic steatohepatitis (NASH) and a Phase 1b trial in paediatric patients.
Cempra president and CEO Prabhavathi Fernandes said: "We are pleased that the FDA has granted Fast Track status for solithromycin IV and capsules in the treatment of CABP.
"We look forward to working with the FDA to streamline the development and review of this promising drug and we currently remain on track to release top line data from our phase three solithromycin IV clinical study conducted in patients with CABP by the end of this year."
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By GlobalDataEarlier, solithromycin IV and capsules received FDA approval to treat CABP and solithromycin capsules to treat gonorrhoea as a qualified infectious disease product (QIDP).
Cempra collaborated with Toyama Chemical, a subsidiary of Fujifilm Holding, for certain exclusive rights in Japan.
The firm’s second product includes Taksta (CEM-102), which is being developed for chronic oral treatment of refractory infections in bones and joints.
Image: A very prominent pneumonia of the middle lobe of the right lung. Photo: courtesy of James Heilman, MD.
