XOMA Advances into Phase II Acne Clinical Trials with XMP.629
Thursday January 22, 7:30 am ET
Topical Compound Targeted for Phase III Decision by Year End
BERKELEY, Calif.--(BUSINESS WIRE)--Jan. 22, 2004--XOMA Ltd. (Nasdaq:XOMA - News) announced today the initiation of a Phase II clinical trial with its XMP.629 peptide, which is being developed as a topical treatment for acne. In several preclinical studies, XMP.629 was found to be a potent agent against Propionibacterium acnes and other related skin microorganisms associated with acne, demonstrating favorable topical properties, safety and rapid bactericidal activity. Phase I studies have also shown favorable properties in terms of skin irritation and penetration.
The Phase II trial is a randomized, double-blind, placebo-controlled, dose-ranging efficacy and safety study of 240 patients with mild-to-moderate acne. Treatment will be administered once daily for 12 weeks as either a placebo or one of three concentrations of XMP.629.
Efficacy will be evaluated based on the decrease in the number of inflammatory lesions, noninflammatory lesions, total lesions and Physician's Global Severity Assessment (a visual evaluation of acne severity based on a five point scale) of each patient during the study. In addition, the safety and tolerability of the drug will be assessed. Current planning is for Phase II initial results and a decision by the end of 2004 on whether or not to enter into Phase III trials.
Acne remains a widespread and frustrating condition that drives an estimated 17 to 28 million Americans to seek some form of treatment. XMP.629 represents a broadening of XOMA's dermatology portfolio, following RAPTIVA(TM), which is approved for marketing as a treatment for moderate-to-severe psoriasis in the U.S.
"We're kicking off 2004 by moving XMP.629 into Phase II clinical trials right on schedule," said John L. Castello, XOMA's chairman, president and chief executive officer. "Our Phase I studies have provided us with positive results, and we anticipate reviewing initial efficacy data later this year. We believe that a potentially significant market opportunity exists for an innovative, effective and safe topical medication that could help acne patients avoid the growing problems of antibiotic resistance and adverse side effects."
About XMP.629
XMP.629 is a synthetic peptide compound derived from bactericidal/permeability-increasing protein (BPI) -- a human host-defense protein that is part of the body's early lines of defense against invading microorganisms. The compound kills acne-causing bacteria.
In preclinical studies, XOMA scientists evaluated antibacterial activity of XMP.629 against P. acnes and other skin flora. They found that the compound, in a proprietary formulation buffer, showed bactericidal activity against P. acnes, including strains resistant to other antibiotics such as erythromycin or clindamycin. Recent Phase I studies in healthy volunteers have shown that topical application of XMP.629 is safe, non-irritating, well tolerated and importantly, does not have measurable systemic absorption. |
