Clinical Trial on RGRN-305 for Hidradenitis Suppurativa

In a recent clinical trial, promising outcomes were discovered for the inhibition of heat shock protein 90 by RGRN-305 for individuals suffering from moderate to severe Hidradenitis Suppurativa (HS), a painful immune-mediated disorder. These results were published in the Journal of the American Medical Association.

The randomized clinical study was conducted from September 22, 2021, to August 29, 2022, at the Department of Dermatology, Aarhus University Hospital in Denmark. The study included 15 patients who met eligibility criteria—aged 18 or older with moderate to severe HS—and aimed to evaluate the feasibility of using RGRN-305, a heat shock protein 90 inhibitor, in treating the disorder.

The patients randomly received either oral RGRN-305, a 250-mg tablet, or a matching placebo once daily for 16 weeks. The primary efficacy endpoint was the percentage of patients achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR-50) at week 16.

The trial demonstrated that the RGRN-305 group outperformed the placebo group in achieving HiSCR-50 at week 16, with 60% compared to 20%, respectively. Secondary endpoints included:

• HiSCR-75 and HiSCR-90
• Dermatology Life Quality Index scores
• A pain numeric rating scale

These also showed significant improvements in the RGRN-305 group.

The safety of RGRN-305 was significant in the study, with no deaths or serious adverse events reported. Treatment-emergent adverse events were equally distributed between the RGRN-305 and placebo groups, indicating that this treatment was well-tolerated.

These highlights suggest that heat shock protein 90 inhibition by RGRN-305 presents a promising mechanism of action against Hidradenitis Suppurativa. The success of this trial underscores the importance of further evaluation in larger-scale cohorts to improve and ease the quality of life of individuals with this painful immune disorder.

Source

Ben Abdallah, H., Bregnhøj, A., Emmanuel, T., Ghatnekar, G., Johansen, C., & Iversen, L. (2023). Efficacy and Safety of the Heat Shock Protein 90 Inhibitor RGRN-305 in Hidradenitis Suppurativa. In JAMA Dermatology. American Medical Association (AMA). https://doi.org/10.1001/jamadermatol.2023.4800