Cempra Pharmaceuticals (CEMP) continues to be one of our favorite long term prospects due to its assets in the antibiotic space and signs of excellent management. We originally covered the company in June of 2013 when the stock was trading in the $7/share range. Since that time, the stock has gained significant investor attention, and should continue to appreciate over time as the company has numerous studies with data due in 2015.
In this article, we will cover the company’s upcoming coming Phase III top-line data release for CEM -101 (Solithromycin), due by the first quarter of 2015, and discuss the drug’s other indications it’s being developed for.
Near Term Catalyst: Top-line data from the Solitaire-Oral Phase 3 Study.
Solithromycin is being studied in Cempra’s largest trial, the Solitaire-IV trial. In this trial, it’s being compared to moxifloxacin in over 800 patients with community acquired bacterial pneumonia (CABP).
Solithromycin is likely the most valuable asset being developed by Cempra. The Drug is a ketolide antibiotic, which is in the macrolide class of antibiotics. In our opinion, results are likely to be positive because of solid Phase II data versus its comparator levoflaxacin. The FDA also is being more lenient with efficacy results because it is looking to expand the types of antibiotics that are on the market.
What may set Solithromycin aside from conventional pneumonia therapies are its possible intravenous-to-oral step-down capabilities. Studies show that 40%-50% of hospitalized pneumonia patients would be successfully treated by switching from IV to oral after 2-3 days of IV.
Step-down therapy requires the continuation of the same antibiotic, but a change in delivery method. By switching from IV to oral, a patient is not required to stay in the hospital. Step-down and switchover therapies are being used more and more by doctors to limit costs and burdens associated with hospital stays. If approved, Solithromycin would be the first macrolide approved in twenty years that has oral and intravenous administrational capabilities.
Due to the mechanism of action of macrolides, adverse effects seem to be dramatically decreased. If this scope of low toxicity can be demonstrated in Phase III trials, Solithromycin has a great shot at approval. The drug received the Qualified Infectious Disease Product Designation from the FDA in September of 2013 for the CABP indication.
In the phase II clinical trial for CABP, Solithromycin was compared to oral Levofloxacin in 132 patients. Not only was non-inferiority reached over levofloxacin, the safety profile of Solithromycin was superior by a vast amount:
