Sunday, October 01, 2017 4:49:00 AM
Basically, they have data showing oral eravacycline achieved therapeutic drug ranges in urine when taken fasting. Thus, the oral formulation of the drug does in fact work just fine. The whole entire fail of the trial back in 2015 leading to a loss of 80% of TTPH share value was all due to people eating before taking the pill......
https://idsa.confex.com/idsa/2017/webprogram/Paper66183.html
Conclusion:
These results support the conclusion that oral dosing in the previous phase 3 study resulted in low ERV exposures and urine concentrations. The exposures and urine concentrations observed with IV ERV are well within the expected therapeutic range and support the efficacy of IV ERV in the treatment of cUTI. Day 7 results in the fasted period indicate that an IV to oral transition dose regimen for ERV is achievable and work is ongoing to optimize dose and meal schedule.
Patrick Horn, MD, PhD, Tetraphase Pharmaceuticals, Watertown, MA, Susan Redican, MS, Clinical Operations, Tetraphase Pharmaceuticals, Watertown, MA and Larry Tsai, MD, Clinical, Tetraphase Pharmaceuticals, Watertown, MA
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