Pruvel is a broad-spectrum fluoroquinolone antibiotic for the treatment of infectious diarrhea, including travelers' diarrhea, which can be caused by a broad range of bacteria. Pruvel is a prodrug, or an inactive form of the compound, that converts in the body to the active form ulifloxacin following oral administration. Ulifloxacin, a compound that inhibits bacterial DNA replication, has demonstrated activity against a wide range of the bacteria that can cause infectious diarrhea.
In February 2009, Optimer reported top-line data from the second pivotal Phase 3 study which shows that Pruvel met the study objective of superiority to placebo in the resolution of diarrhea, measured by Time to Last Unformed Stool (TLUS). Pruvel showed a statistically significant benefit compared to placebo in TLUS in both the mITT (modified intent-to-treat; n=200) and microbiologically evaluable (per protocol; n=173) populations. The median TLUS for patients treated with Pruvel was 32.8 hours; this was significantly different from the TLUS for placebo with a p-value of <0.0001. This trial confirmed the overall efficacy and safety profile observed in the previous Phase 3 trial, demonstrating that Pruvel was generally well tolerated and had a similar safety profile compared to placebo. This was the second of two pivotal Phase 3 clinical studies performed in preparation for a NDA filing with the U.S. Food and Drug Administration.
Data from the first Phase 3 study, referenced as OPT-099-001, was announced in July 2008, and also showed that Pruvel met the primary endpoint of TLUS in both the mITT (n=187) and microbiologically evaluable (n=165) populations compared to placebo. The median TLUS for patients treated with Pruvel in the first Phase 3 trial was approximately 24 hours, which was significantly different from the median TLUS for placebo with a p-value of <0.0001.
We intend to conduct a Phase 4 trial subsequent to NDA submission to compare Pruvel to ciprofloxacin, an antibiotic commonly used to treat infectious diarrhea.
We believe that Pruvel is active against a broad set of gastrointestinal pathogens, has a favorable safety profile and has a more convenient dosing regimen than current treatments for travelers' diarrhea.
Infectious diarrhea can be caused through infection by bacteria, viruses or parasites. Travelers' diarrhea is infectious diarrhea contracted by the ingestion of contaminated food or water by travelers to a developing country. Symptoms include stomach cramps, vomiting, nausea, fever and headache. Approximately 85% of travelers' diarrhea cases are caused by bacteria, such as E. coli, Shigella, Salmonella, or Campylobacter. The limitations of currently available antibiotics for infectious diarrhea include limited spectrum of activity, antimicrobial resistance, possible side effects, and poor compliance, which can reduce successful outcome.
Pruvel is approved in Japan, Korea and several European countries for the treatment of various bacterial diseases including respiratory and urinary tract infections, skin infections, infectious enteritis, cystitis, and prostatitis. Optimer acquired exclusive rights to discover, develop and commercialize Pruvel in the U.S. from Nippon Shinyaku Co., Ltd., in June 2004.
