XBiotech is using a subcutaneous injectable formula of bermekimab to safely and conveniently stop the chronic inflammation associated with acne - to help resolve both skin lesions and mental health issues associated with the disease. The Phase II clinical study evaluated treatment in moderate to severe acne vulgaris, headed by leaders in the dermatology community including Dr. Ronald Moy, recent President of the American Academy of Dermatology, former Co-Chief of Dermatology, and Chief of Dermatological Surgery at UCLA Medical Center.

Therapeutic Opportunity

Acne vulgaris affects more than 40 million persons in the U.S. Most adolescents suffer from some degree of acne and up to 51 percent of adults may suffer from acne into their fourth decade. The underlying cause of acne is not clear, inflammation of pilosebaceous follicles is known to be a central feature of the disease; where in severe cases, subsequent cyst and nodule formation result in permanent scarring.

While almost everyone is familiar with the skin manifestations, relatively few are aware that acne vulgaris is associated with serious psychological disturbances and in some cases even mortality due to suicide. In fact, depression and anxiety associated with acne is reportedly more severe in acne patients than in many other serious chronic, non-psychiatric medical conditions.

Current treatments exist, but are often associated with:

  • Exacerbation of depression
  • Psychosis
  • Suicide ideation

No therapy currently exists to treat both the skin manifestations of acne as well as the psychological complications.

Anti-IL-1α Antibody Therapy

Several avenues of research point toward the chronic inflammatory cytokine IL-1α as playing a key role in microcomedone formation and hypercornification. Skin biopsies of acne vulgaris reveal the presence of IL-1α.

As a result, antibody therapy could be expected to reduce inflammatory acne lesions. Furthermore, in the hypothalamus, IL-1α can trigger the cells to signal the presence of danger signals resulting in perception of anxiety or depression.

The True Human™ antibody under development for the treatment of acne provides a highly targeted blockade of IL-1α. Results from a recent Phase I/II study have provided the basis to conduct advanced clinical study in this indication. The results showed continual improvement in lesions, with up to a 36 percent reduction after eight weeks, and statistically significant improvement in patient anxiety.

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