Sol-Gel has announced positive interim results in its Phase II clinical trial for its treatment for acne using its drug, called Twin. The company met the trial targets, with statistical significance.
Sol-Gel was acquired three years ago by Arkin Holdings, controlled by Mori Arkin, for $17 million. The company was previously mentioned as a candidate for a Nasdaq IPO at a $150 million company value.
The offerings market has recent begun heating up again, after a period in which few offerings took place, so it is possible that plan to hold an IPO for the company may be resuscitated.
Sol-Gel's product is based on a unique method of wrapping the molecule developed by the company that makes it easier for the drug to penetrate the skin. In the case of the acne drug, the company has combined two known drugs for acne that could previously be administered only separately, not together. Sol-Gel's molecule wrapping has already been used successfully in a line of protective cream products. This product line was sold for $8 million in order to finance Sol-Gel's drug development.
The current trial is being conducted on 726 patients in 36 medical centers in the US. The combined product was preferable by any criterion, and the product was shown to be safe, with no severe negative events.
“The results from the Phase II trial are a major step towards establishing Sol-Gel as a pure-play dermatology company that provides patients with innovative drug therapies for multiple skin diseases,” Arkin said.
"Based on the Phase II trial efficacy, tolerability and safety results, TWIN has the potential to become a preferred treatment for acne by dermatologists and their patients,” said Jefferson Medical College clinical Professor of dermatology Guy Webster, the mentor for the trial.
Based on these results and subject to an end of Phase II meeting to be scheduled with the U.S. Food and Drug Administration (FDA), Sol-Gel plans to initiate a Phase III program.
Published by Globes [online], Israel Business News - www.globes-online.com - on July 23, 2017
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