Optimer Pharmaceuticals Awarded Grant from the National Institutes of Health for Development of OPT-80 to Treat Deadly Hospital
Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) has been awarded a $1 million annual federal grant which will be applied to the late-stage development of OPT-80 to treat Clostridium difficile-Associated Diarrhea (C. Difficile), or CDAD. C. difficile is a bacterial strain that can accumulate in the gut causing severe diarrhea and is potentially more lethal than Methicillin-Resistant Staphylococcus Aureus (MRSA), according to the Centers for Disease Control and Prevention (CDC).
C. difficile is a major cause of nosocomial (hospital associated) diarrhea worldwide and the CDC estimates it affects as many as 500,000 people each year in the United States alone. In response, the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), is sponsoring the initiative titled, “New Treatment for C. difficile-Associated Diarrhea (CDAD),” and has awarded Optimer a grant to fund the project. The $1 million grant is renewable each year until August 2010 to a maximum of $3 million over a three year funding period.
CDAD typically develops from the use of broad-spectrum antibiotics that alter normal gastrointestinal (gut) flora, allowing C. difficile to flourish and produce toxins that disrupt the intestinal lining, cause cell death and inflammation with ensuing diarrhea. Approximately 20 percent of treated patients develop single or multiple recurrences of CDAD, which may require repeated hospitalization and persistence of symptoms for years.
Tessie M. Che, Ph.D., Chief Operating Officer and Senior Vice President, Corporate Affairs at Optimer, underscored the grave threat posed by CDAD and reaffirmed Optimer’s ongoing commitment to the search for a more effective treatment by saying, “CDAD is a serious disease which we believe is highly underreported. The award of this grant from the NIH validates the technical and commercial merit of our OPT-80 program. We are grateful and appreciate the NIH’s continuing support of Optimer’s lead anti-infective drug candidate.”
OPT-80, formerly known as PAR-101 or Difimicin, is a narrow spectrum antibiotic in development to treat CDAD. OPT-80, which is cidal against (i.e., kills) C. difficile, is unlike the current FDA-approved treatment which only inhibits bacteria growth. OPT-80 has shown selective activity against C. difficile while leaving the healthy intestinal flora intact. This selective activity, while eliminating the infection, may preserve the natural balance of flora in the GI tract.
Farah Babakhani, Ph.D., Principal Investigator and Group Leader at Optimer, described the NIH grant which supports Optimer’s research and development efforts by saying, ”This Phase II NIH award will allow the examination of the gut flora as a supplementary study to the ongoing OPT-80 trials to confirm narrow spectrum activity and potency of OPT-80 against hypervirulent epidemic strains. Moreover, the award will support additional toxicology and microbiological studies to further demonstrate the safety and efficacy of this compound and its major metabolite in CDAD patients. It will also support a surveillance study of C. difficile isolates across North America to compare the activity of OPT-80 with existing CDAD treatments.”
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products for the treatment of serious infections. Optimer has two late-stage anti-infective product candidates. OPT-80, currently in two pivotal Phase 3 clinical trials, is being developed for the treatment of Clostridium difficile-associated diarrhea, the most common hospital-acquired diarrhea. Prulifloxacin, also in two pivotal Phase 3 clinical trials, is an antibiotic being developed for the treatment of travelers’ diarrhea, a form of infectious diarrhea. Additional information regarding Optimer can be found at http://www.optimerpharma.com.