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Phase II Clinical Trials Initiated for XMP.629, Potential Acne Treatment

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.

About acne vulgaris
Acne is a multi-factorial disease that affects the sebaceous (oil-producing) hair follicles (pores) of the skin, primarily on the face and neck, but often on the back and chest as well, where hairs grow most densely. The current understanding of the disease is that increasing levels of androgen sex hormones at puberty lead to increased production of oils and epidermal cells lining the follicles. In its less severe forms, acne is characterized by non-inflammatory papules (comedones, whiteheads or blackheads), which are pores plugged by excessive sebum production and trapped skin cells. In more severe cases, patients develop inflammatory lesions, in which the common and generally non-pathogenic skin bacterium P. acnes plays a significant role.

According to the American Academy of Dermatology, acne vulgaris affects nearly 100% of adolescents and nearly half of adults over 25 in the U.S. Various sources estimate that 15-40% of Americans seek medical treatment for acne by their mid-teens. Every year, five million prescriptions for oral antibiotics are dispensed for acne treatment in the U.S. Additionally, U.S. prescription and over-the-counter sales of topical acne treatments total approximately $1.1 billion per year.

Although not a serious threat to general health, acne is one of the most socially distressing skin conditions, especially for adolescents, who must deal with a disfiguring disease that erupts just when sexual maturity makes them most sensitive about their appearance. Moreover, severe acne can lead to permanent scarring of the skin that carries the social distress throughout adulthood.

About existing treatment regimens
The goal for acne treatment is to clear existing lesions and prevent new ones from occurring. Current topical treatments for acne include benzoyl peroxide, retinoids, salicylic acid and antibiotics such as erythromycin and clindamycin. Broad-spectrum oral antibiotics, retinoids and hormone treatments are also prescribed, although many of these treatments produce undesirable and even dangerous side effects. Topical antibiotics kill off and decrease the population of P. acnes within follicles, as well as reduce the ability of this organism to generate pro-inflammatory molecules.

An important issue in the use of topical antibiotics is the emergence of bacterial resistance and crossresistance, which can also occur with repeated courses of systemic antibiotics. Therefore, a topical treatment that is effective against P. acnes and does not induce resistance would offer an attractive alternative to currently available topical acne products.

Source: XOMA Ltd.

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