Acne vulgaris (Acne), a disease associated with certain strains of Propionibacterium acnes (P. acnes) that colonize the pilosebaceous units of human skin (Figure 1), affects about 10% of the world's population and is the eighth most prevalent disease worldwide. Yet despite its enormous prevalence, there have been no fundamental advances in treatment for the last 30 years. The newest FDA-approved drug is Cabtreo, a topical combination of three drugs (adapalene, clindamycin, benzoyl peroxide) that have separately been available over the counter for decades. Other combinations of old drugs are also in development, and old classes of drugs that have been chemically modified are also in development. There are several reasons for this relative lack of innovation in acne treatment: 1. Acne does not cause mortality, and its morbidity is due primarily to its understandable emotional and psychological impacts rather than physical disability. 2. There is a plethora of treatments available without prescription. 3. The interaction of specific P. acnes lines and human skin has only recently been elucidated on the molecular and genomic level and has not yet been exploited in drug development.
Regarding the genomic and molecular understanding of acne, researchers at the University of California, San Diego, have recently shown that two different lineages of P. Acnes colonize human skin. One type is associated with healthy skin, and the other has genetic mutations that cause inflammation and, presumably, acne. These researchers are now leveraging these differences as targets for developing acne vaccines. However, these vaccines are many years from clinical trials. The large drug company Sanofi lists an mRNA vaccine for acne in its early clinical pipeline. The first (Phase 1) study in humans was completed in November of 2023, and results have not been published. If the Phase 1 trial was successful, the company would still need to complete Phases 2 and 3 of development and is thus many years away from possibly being commercialized.
Dermata Therapeutics, Inc. has what they describe as a novel acne treatment in Phase 3 trials. DMT310 is a once-weekly topical product candidate derived from Spongilla, a freshwater sponge. The company expects topline results in March 2025. DMT310 is an unusual candidate for FDA drug development as it is a naturally derived extract mixture of physical and chemical active agents. The vast majority of drugs that enter the FDA approval process have single active ingredients or are combinations of already approved drugs. Moreover, numerous Spongilla extracts for skin application are already available over the counter, and classifying DMT310 as a novel treatment may be unwarranted.
The bottom line is that no novel breakthrough prescription acne treatments are on the market or close to commercialization. However, significant advances on the genomic and molecular levels elucidating why some lines of P. acnes are pathogenic and others are not may provide new targets for drug and vaccine development.
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Assessed and Endorsed by the MedReport Medical Review Board