Data show that MABp1 has led to rapid improvement in skin lesions and acne-associated psychological symptoms.
Findings are published in the June 2015 issue of Journal of Drugs in Dermatology. (J Drugs Dermatol. June 2015;14(6):560-564)
XBiotech, Inc. (XBIT-NASDAQ) announced this morning the publication of Phase 2 clinical results for its True Human™ Antibody used as a treatment for acne vulgaris. This study used a next-generation antibody called MABp1, which works to block the activity of interleukin-1 alpha (IL-1α), a pro-inflammatory protein, in the body. The IL-1α gene is present in healthy individuals and has a beneficial role as part of the immune response to injury. However, IL-1α can also have a negative impact as a result of stimulating local and systemic inflammation and swelling, damaging tissues, and lowering pain thresholds, among other actions. The role of IL-1α in acne suggests that an anti-IL-1α antibody therapy may help reduce inflammatory acne lesions, as well as depression and other acne-related conditions, due to an impact on the chronic inflammatory process. IL-1α starts the inflammation response and then sends a message to the brain to give the injury response, thus it is possible that the anxiety and depression frequently associated with acne may actually be physiologically related to the inflammatory process.
To test this approach, Austin, Texas-based biotechnology company XBiotech, Inc. conducted an open-label Phase 2 clinical study of 10 patients with moderate to severe acne. These patients received three subcutaneous injections of MABp1 monotherapy over a six-week period and were followed for a total of 70 days to assess safety and efficacy endpoints. As reported by XBiotech, MABp1 showed excellent tolerability in the study, with no serious adverse events reported and only few mild adverse events. Disease severity, as measured by inflammatory lesion count, improved consistently, with a median 36% reduction by day 56. MABp1 monotherapy also resulted in clinically meaningful improvements in anxiety/depression and body image scores using two clinically validated questionnaires: (1) the Hospital Anxiety and Depression Scale (HADS), which showed a median score of 6 reduced to 1 on day 56; and (2) the Body Image Disturbance Questionnaire (BIDQ), which showed a mean overall score improved from 2.3+.9 to 2.1+.1.
As a result, XBiotech writes that "MABp1, due to its unique molecular target, may be a safe and effective means of treating not only inflammatory acne lesions, but also improving feelings of depression and anxiety commonly associated with acne." This study is further believed to be the first to show a link between the physical and mental symptoms of acne, and moreover, the first to show a single agent capable of treating both aspects.
Acne may represent a considerable market opportunity for XBiotech, given the favorable safety and tolerability profile of MABp1 shown to date. Existing medications for severe acne that cannot be controlled through over-the-counter means center on the use of isotretinoin (brand names Claravis, Accutane, and others), which is a high-risk compound characterized by frequent side effects and products with carefully controlled distribution. Consequently, a more tolerable alternative to treating moderate to severe acne without exacerbating the associated psychological conditions is needed. XBiotech anticipates needing a large-scale trial in order to establish the database of safety information required for this indication, which could be a possible path for the company in the future.
XBiotech is engaged in discovering, developing, and translating natural human immunity into novel therapeutic antibody products. These “true human” antibodies may enable faster development of potentially safer, more efficacious antibody therapies. Moreover, XBiotech has developed a streamlined approach to biologics manufacturing that is believed to offer lower development costs, shorter lead times, greater reliability, and more flexible production than conventional techniques. The company’s product development centers on the use of its True Human™ antibodies, which are cloned directly from a human gene, as opposed to using antibodies that are engineered or derived from animal immunization procedures. XBiotech’s lead True Human™ antibody therapy, Xilonix™, is currently in Phase III clinical trials for advanced colorectal cancer in both the U.S. and Europe. Proof-of-concept for the company’s True Human™ therapeutic has also been established with favorable data to date in non-small-cell lung cancer (NSCLC), vascular disease, pyoderma gangrenosum (PG), acne, psoriasis, and type 2 diabetes. Additionally, XBiotech recently launched a Phase I/II study to assess its True Human™ antibody therapy for the treatment of Staphylococcus aureus infections, and has begun using the True Human™ technology to develop a therapy for Ebola virus infection. XBiotech is a Canadian company headquartered in the U.S., with wholly owned subsidiaries in the U.S., Switzerland, Germany, and Japan.