Sol-Gel Announces New Data for SGT-510 for Psoriasis

Sol-Gel Technologies, Ltd. announced positive pre-clinical data for SGT-510, its topical roflumilast drug candidate for the treatment of psoriasis.¹

The study has investigated a human psoriasis xenograft mouse model, made of immunodeficient mice transplanted with healthy human skin, and used it to validate many approved topical and systemic dermatology products. For the trial, the human xenograft animal model was brought on with psoriasis by injection of activated allogeneic interleukin (IL)-2-enriched peripheral blood mononuclear blood cells isolated from patients diagnosed with psoriasis. The mice were then treated with different topical agents and assessed.

All of the treatments were applied once or twice a day for 14 days. The results were as follows:

• After a twice-daily application of dexamethasone, the positive control, 9 of 10 mice recovered.
• After a once-daily treatment of a vehicle cream, the negative control, none of the mice recovered.
• After a once-daily application of roflumilast 0.3%, formulated by Sol-Gel with a conventional method, 3 out of 10 mice recovered.
• After only daily application of SGT-510, 6 out of 10 mice recovered.

Based on the above, Sol-Gel has decided to file a provisional patent application for SGT-510. By the end of 2022, Sol-Gel expects to have to have more head-to-head comparative data against the roflumilast cream 0.3% and expects to start a phase 2 trial after.

Mori Arkin, executive chairman of the board of Sol-Gel, Ness Ziona, Israel, commented that while the study does not represent a formal statistical analysis, the company is pleased with early-stage results and thinks it is worthy of patenting. 

Arkin also went into detail about SGT-510, meant as an alternative to steroid medicine for patients diagnosed with psoriasis.

“Sol-Gel intends to develop SGT-510 in accordance with the 505(b)(2) regulatory pathway by only referencing the oral roflumilast brand DALIRESP. The rationale for this carefully planned regulatory strategy is to create a clear path to market, with no litigation requirement,” said Arkin. “As we plan to develop more than one roflumilast product, including potential combination products, we may also utilize alternative regulatory strategies. Our deep involvement in topical generics along with the supportive view of independent intellectual property experts guides us to believe that there is a significant risk that present patents and patent applications for roflumilast 0.3% cream may be unable to prevent early genericization of the roflumilast products currently under development. Should this be the case, our innovative formulations of roflumilast, if approved by the FDA, would give us the opportunity to become a leading player in the multi-billion-dollar psoriasis and atopic dermatitis markets in the second half of the decade.”

There are also studies planned for the SGT-310, a 1% tapinarof cream, which Sol-Gel plans to submit a New Drug Application (NDA) for and SGT-210, an erlotinib gel.

Reference:

1. Ltd S-GT. Sol-gel announces pipeline update and future development plans. GlobeNewswire News Room. Published June 28, 2021. Accessed July 12, 2021. https://www.globenewswire.com/news-release/2021/06/28/2253641/0/en/Sol-Gel-Announces-Pipeline-Update-and-Future-Development-Plans.html