If you have ever personally contracted or know anyone who has contracted hospital or long-term care born internal infection, there is a bit of good news this morning. Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) released some positive top-line results from its pivotal Phase III clinical study of Optimer’s lead anti-infective drug candidate, OPT-80, in patients with Clostridium difficile Infection (CDI).
ViroPharma (NASDAQ: VPHM) makes the competing drug called Vancocin, and its shares are down 5.7% at $11.85 in pre-market trading.
CDI is a growing problem in hospitals, long-term care facilities and in the community as a serious illness caused by infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. CDI typically develops from using broad-spectrum antibiotics that disrupt normal gastrointestinal flora, allowing C. difficile bacteria to flourish. Current therapeutic options for CDI include metronidazole and oral vancomycin; but approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of antibiotic administration. CDI currently has limited treatment options and affects more than 500,000 patients in the United States on an annual basis alone.
Optimer said that 92.1% of patients treated with OPT-80 achieved clinical cure vs. 89.8% for Vancocin. In addition, only 13.3% of patients treated with OPT-80 experienced a recurrence vs. 24.0% for Vancocin. Patients treated with OPT-80 had a global cure with no recurrence within four weeks of 77.7%, which was greater than Vancocin at 67.1%. OPT-80 was well-tolerated. The company’s next step is to complete the on-going second Phase III study at clinical sites in Europe and North America to support an NDA filing.
This is the first of two pivotal Phase III trials and highlights the important differentiating features of OPT-80, including lower recurrence and higher global cure rate than Vancocin, the only FDA approved antibiotic for the treatment of CDI.
The OPT-80 clinical trial is the largest single comparative study ever conducted against Vancocin. The detailed data from the study will be presented at a medical conference in the near future. Top-line trial results are summarized in the table below.
Jon C. Ogg
November 11, 2008
