WASHINGTON, Dec. 16 /PRNewswire-FirstCall/ -- Inhibitex, Inc. today presented results from a Phase II clinical trial evaluating Aurexis as a first-line therapy, in combination with standard of care antibiotics, for serious, life-threatening Staphylococcus aureus (“staph”) bloodstream infections at the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, DC. This study was primarily a test of safety and pharmacokinetics, but also represents an initial step in assessing the potential of Aurexis to improve cure rates over current standard of care therapy.
Dr. J. John Weems, Professor of Medicine, Department of Medicine, Medical University of South Carolina, a lead investigator in the study, presented results from the 60-patient Phase II trial. Patients with both hospital- associated and community-acquired staph bloodstream infections were included in the trial. Positive trends were observed in the composite primary endpoint of mortality, relapse rate and infection-related complications, and a number of secondary endpoints, including the progression in the severity of sepsis and days in the intensive care unit. Based on these findings, Inhibitex plans to initiate additional clinical studies in this indication in 2006.
“More than 60,000 cases of staph bloodstream infection occur annually in the United States,” Dr. Weems reported to the conference attendees. “Associated mortality and relapse rates remain unacceptably high, and metastatic complications affect approximately one-third of these patients. Increasing antibiotic resistance to staph emphasizes the need for alternative approaches to current therapy.”
Serious infections caused by staph represent a growing problem at hospitals, particularly as bacterial resistance to existing antibiotics increases. One-half of the patients in the Inhibitex study had infections caused by staph that were resistant to the most commonly used antibiotics. In addition to the challenges these infections pose to hospitals, staph infections that are serious and often resistant to antibiotics are now appearing in the community at an increasing rate. In fact, in the Inhibitex study, approximately 30% of the patients had infections that originated in the community, not in the hospital.
“Unfortunately, it is becoming evident that the development of new antibiotics is not improving outcomes or keeping pace with the increasing rates of antibiotic resistance among bacteria,” said Dr. William Johnston, CEO of Inhibitex. “Our strategy at Inhibitex is to develop novel antibody-based drugs that augment current antibiotics, resulting in significantly improved therapeutic outcomes.”
About Aurexis Phase II Trial
The Phase II trial was a randomized, placebo-controlled, double-blind study of 60 patients with documented staph bloodstream infections. Patients were randomized to one of two arms; standard of care antibiotic therapy plus placebo, or standard of care antibiotic therapy plus Aurexis (single administration at 20mg/kg). Nearly 60% of the patients already had serious complications from their staph infection at the time of diagnosis. Four patients in the group that received antibiotics alone met the primary composite endpoint, compared with two in the group that also received Aurexis. The other primary objectives of the study were pharmacokinetics (PK) and safety. The PK profile indicated that the plasma levels of Aurexis were lower in infected patients than those observed in healthy subjects in an earlier Phase I trial. Comparison of adverse events and laboratory values between the groups demonstrated that Aurexis was generally safe and well tolerated in this patient population. Among the secondary endpoints, progression in severity of sepsis was observed in four patients in the group that received antibiotics alone and none in the group that also received Aurexis. Total hospital days were similar for both groups of patients; however of those patients admitted to the ICU, the median duration of stay in the ICU was seven days for patients who received antibiotics alone compared to three days for patients who also received Aurexis. The median duration of mechanical ventilation use was eight days for those receiving Aurexis compared to four days for patients receiving antibiotics alone. The trial was not powered to show statistically significant differences in the primary endpoint between the cohorts. The study was conducted at 12 leading infectious disease hospitals within the United States.
About Staph Infections
Staph is one of the leading causes of hospital-associated infections. There were an estimated one million hospital-associated staph infections worldwide in 2002, of which over 225,000 occurred in the United States.
According to the Centers for Disease Control and Prevention (CDC) and other sources, the percentage of hospital-associated staph infections in intensive care units in the United States caused by methicillin-resistant staph, or MRSA, doubled from 1994 to 2002, increasing from 30% to nearly 60%. The mortality rate for bloodstream infections associated with MRSA is 30% to 50%. Studies indicate that patients that acquire a MRSA bloodstream infection, as compared to those that do not, require on average, an additional 12 days in an intensive care unit at an average cost of $27,000.
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on the discovery, development and commercialization of antibody-based products for the prevention and treatment of serious, life-threatening infections. The Company currently has five drug development programs, all of which are based on its proprietary MSCRAMM protein platform technology. The Company’s most advanced product candidates are Veronate and Aurexis, both of which are in various stages of clinical development. The Company has retained world-wide rights to both of these programs. The Company’s three preclinical programs include a collaboration and joint development agreement with Dyax to develop fully human monoclonal antibodies against MSCRAMM proteins on enterococci and a partnership with Wyeth to develop staphylococcal vaccines. For additional information about the Company, please visit www.inhibitex.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements other than statements of historical facts included in this press release, including statements regarding the Company’s interpretation of results from its Aurexis Phase II clinical trial and its intention to initiate additional clinical trials of Aurexis in 2006 are forward-looking statements. These plans, intentions, expectations or estimates may not actually be achieved and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including unanticipated safety or regulatory issues and other cautionary statements contained elsewhere herein, in its Annual Report on Form 10-K for the year ended December 31, 2004 and in risk factors described in or referred to in greater detail in the “Risk Factors” section of the Company’s prospectus, which forms part of its Registration Statement on Form S-3, which, as amended, was declared effective by the Securities and Exchange Commission or SEC on September 21, 2005. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release.
There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company’s business, financial condition, results of operations, and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward- looking statements, by these cautionary statements.
Inhibitex(R), MSCRAMM(R), Veronate(R) and Aurexis(R) are registered trademarks of Inhibitex, Inc. (R)
CONTACTS: Inhibitex, Inc. Russell H. Plumb Chief Financial Officer (678) 746-1136 rplumb@inhibitex.com Lilian Stern (Investors) Stern Investor Relations, Inc. (212) 362-1200 lilian@sternir.com Kathryn Morris (Media) KMorrisPR (845) 635-9828 kathryn@kmorrispr.com
Inhibitex, Inc.
CONTACT: Russell H. Plumb, Chief Financial Officer of Inhibitex, Inc.,+1-678-746-1136, rplumb@inhibitex.com ; or Investors, Lilian Stern of SternInvestor Relations, Inc. +1-212-362-1200, lilian@sternir.com ; or Media,Kathryn Morris of KMorrisPR, +1-845-635-9828, or kathryn@kmorrispr.com
Web site: http://www.inhibitex.com//
