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cempra inc (CEMP) Key Developments

Cempra, Inc. - Special Call

To discuss on positive topline phase 3 clinical results

Cempra, Inc. Announces Positive Topline Phase 3 Clinical Results for Oral Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia

Cempra, Inc. announced positive topline results from a global, pivotal Phase 3 clinical trial of solithromycin oral capsules (Solitaire-Oral) in the treatment of patients with community acquired bacterial pneumonia (CABP). In the intent-to-treat population (ITT, all randomized patients), solithromycin met the primary objective of statistical non-inferiority (10% non-inferiority margin) of the early clinical response at 72 (-12/+36) hours after initiation of therapy compared to moxifloxacin. Solithromycin also met the secondary objectives of non-inferiority in clinical success at the short term follow up (SFU) visit, 5-10 days after the end of therapy, both in the ITT and clinically evaluable populations. The point estimates for the primary endpoint of early clinical response were 78.2% for solithromycin and 77.9% for moxifloxacin. The 95% confidence interval for the treatment difference had lower and upper bounds of -5.5% and 6.1%, respectively. The results were similar in the combined total patient population, however, initial sub-groups analysis by age, indicate that the difference in point estimates became larger with increasing age and favored solithromycin in the ITT early clinical response groups. The results for the secondary efficacy endpoints supported results from the primary endpoint. This study was the first to be completed under the proposed FDA CABP guidance which allows for assessment of the new primary endpoint of early clinical response in the pooled mITT population (ITT population with microbial isolates) across two similar Phase 3 trials, utilizing a 12.5% non-inferiority margin. In this first study, solithromycin met the secondary objective of non-inferiority of the early clinical response in the mITT population. Although, the individual mITT was analyzed, the weighted pooled mITT from the two Phase 3 studies is the true secondary outcome for the NDA. This Phase 3 study, Solitaire-Oral, was a double-blind, active-controlled global, multi-center trial that enrolled 860 adult patients with moderate to moderately severe CABP (pneumonia of PORT Class II, III and IV severity classification). Enrollment of PORT Class II pneumonia patients was limited to 50% of the study population. Patients were randomized to receive either oral solithromycin, as an 800 mg loading dose followed by 400 mg once daily for a total of five days, while oral moxifloxacin was dosed at 400 mg once daily for seven days. The primary objective was demonstration of non-inferiority of early clinical response at 72 (-12/+36) hours, as specified by FDA guidance, defined as having improvement in at least two of the following four symptoms (without worsening of any); cough, shortness of breath, chest pain and sputum production in the ITT. The study was designed to provide 90% power to demonstrate non-inferiority in early clinical response rate for solithromycin versus moxifloxacin utilizing a 10% non-inferiority margin. Secondary endpoints included the clinical success rate at the short term follow up visit 5 to 10 days following the last dose of study drug in the ITT and clinically evaluable populations, and importantly, a comparison of safety and tolerability of solithromycin compared to moxifloxacin. In this clinical trial, serious adverse events (SAEs) occurred with equal frequency in both arms (< 7% of patients) and no SAEs were considered study drug related. The most frequently reported adverse events for solithromycin were headache (4.5%, versus 2.5% incidence with moxifloxacin), diarrhea (4.2%, versus 6.5% with moxifloxacin), nausea (3.5%, versus 3.9% with moxifloxacin), emesis (2.4% versus 2.3% with moxifloxacin) and dizziness (2.1% versus 1.6% with moxifloxacin). No other treatment emergent adverse events occurred, in either arm, with 2.0% incidence or greater. C. difficile associated diarrhea was diagnosed in two patients, both of whom received moxifloxacin. Asymptomatic, reversible alanine transaminase (ALT) elevation was observed in both treatment arms. Grade 3 ALT elevation (>3-8xULN) occurred in 2.1% of moxifloxacin patients and 4.6% of solithromycin patients. Grade 4 ALT elevation (> 8xULN) occurred in 1.2% of moxifloxacin patients and 0.5% of solithromycin patients. No patient in either arm of the study developed treatment emergent elevation of both ALT and bilirubin defined by Hy's Law criteria.

Cempra, Inc. Presents at Guggenheim One on One Day 2014, Dec-16-2014

Cempra, Inc. Presents at Guggenheim One on One Day 2014, Dec-16-2014 . Venue: Langham Hotel, Boston, Massachusetts, United States.

Cempra's Is Not Looking For A Buyer

Cempra, Inc. (NasdaqGS:CEMP) has no plans for now to sell itself, its Chief Executive Officer said, brushing off talk that Cempra is a potential target as big drugmakers set their sights on antibiotic developers. "We are not focused on selling the company. I know a lot of other biotechs are," Cempra Chief Executive Prabha Fernandes said in an interview. Fernandes added, "There's no reason for (a buyer) to offer us anything right now. Why can't they just wait and buy us later if need be? I don't think anyone going to rush to do anything."

Cempra, Inc. Presents at Oppenheimer 25th Annual Healthcare Conference, Dec-10-2014 01:35 PM

Cempra, Inc. Presents at Oppenheimer 25th Annual Healthcare Conference, Dec-10-2014 01:35 PM. Venue: The Crowne Plaza Hotel, New York, New York, United States. Speakers: Mark W. Hahn, Chief Financial Officer and Executive Vice President, Prabhavathi B. Fernandes, Founder, Chief Executive Officer, President and Director.

 

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