Sol-Gel pipeline update 2020

Sol-Gel Technologies Ltd., a clinical-stage dermatology company, recently provided updates for three drugs in their pipeline: SGT-210 (erlotinib gel), tapinarof and roflumilast, and shed a light on their projected goals for 2020.

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According to the press release, the company expects results from a phase 1 study of SGT-210 for the treatment of punctuate palmoplantar keratoderma type 1 in the first half of 2021. There are also plans to initiate pre-clinical trials to examine the use of SGT-210 to treat other skin conditions, including superficial squamous cell carcinoma and plaque psoriasis. Additionally, researchers from Sol-Gel plan to also study the drug’s effect in combination with their other novel drug, roflumilast, on inflammatory conditions such as hidradenitis suppurativa and prurigo nodularis.

The company also notes they recently filed 15 provisional patent applications for roflumilast, a PDE4 inhibitor, and tapinarof, an aryl hydrocarbon receptor agonist, as mono or combination therapies for the treatment of psoriasis as well as other skin conditions.

Mori Arkin, Sol-Gel’s chairman of the board of directors, says the company will continue to monitor the progress of tapinarof after successful phase 2b clinical results as a non-steroidal topical product and expects to file and new drug application (NDA) for the drug in 2021 after phase 3 trials have been completed.

“Strategically, given our extensive IP research, we believe we will be able to launch our first branded tapinarof product in the U.S. in approximately 5.5 years following the approval of the originators tapinarof branded product,” says Arkin. “With respect to topical roflumilast, we estimate a significantly shorter timeline between launch of the first branded topical roflumilast and our branded product.  However, regardless of our convictions, there is inherent risk in drug development including clinical, legal, and regulatory with no guarantee on our launch timeline.”

This year, the company anticipates submitting NDAs both for their microencapsulated benzoyl perozide 3% and microencapsulated tretinoin 0.1% cream (Twyneo, Sol-Gel) for the treatment of acne vulgaris and their microencapsulated benzoyl peroxide 5% cream (Epsolay, Sol-Gel) for the treatment of papulopustular rosacea. Both drugs demonstrated positive phase 3 data in 2019.

The NDA for Epsolay is expected to be submitted by the first half of 2020 and the NDA for Twyneo is expected in the second half of 2020.

“2019 proved to be a transformational year, marked by our significant clinical progress, including positive Phase 3 results for our Epsolay and Twyneo programs,” says Alon Seri-Levy, Chief Executive Officer of Sol-Gel, in a press release.

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“We are eager to build on this progress in 2020, with the addition of new pre-clinical programs for the treatment of psoriasis and other dermatological disorders. We are excited by the prospect of making a change in the lives of severely afflicted patients in the U.S. and worldwide, while preparing for two key NDA submissions for the treatment of papulopustular rosacea and acne vulgaris,” he says.

References:

BioSpace. Sol-Gel Provides Product Pipeline Updates and Anticipated Milestones for 2020. BioSpace. https://www.biospace.com/article/releases/sol-gel-provides-product-pipeline-updates-and-anticipated-milestones-for-2020/. Published February 5, 2020. Accessed February 7, 2020.