FDA fast track status aiming to speed TolaSure Gel to fragile skin patients

Biomendics’ BM-3103, formulated as TolaSure Gel for epidermolysis bullosa simplex (EBS), has been granted fast track status by the U.S. Food and Drug Administration (FDA) for treating people with fragile skin due to EBS.

The new designation could accelerate the development and review of the topical treatment if the gel proves safe and effective in clinical studies.

With fast track status, Biomendics can communicate more frequently with the FDA and receive regulatory guidance during the treatment’s development. The designation also allows parts of the marketing application to be reviewed as they are completed, rather than waiting for all clinical data to be submitted, thus speeding the review process.

Being on the fast track may also enable priority review, shortening the time the FDA takes to decide whether or not to approve the treatment.

“This designation is a significant milestone for BioMendics and, more importantly, for the individuals and families living with Epidermolysis Bullosa Simplex,” Karen McGuire, PhD, CEO of Biomendics, said in a company press release. “Combined with our Orphan Drug and Rare Pediatric Disease designations, Fast Track positions BM-3103 for an accelerated development path.”

The company is now testing the safety and early effectiveness of BM-3103 in a Phase 2 clinical trial called TAMES-02 (NCT07027345). That study, slated for completion later this year, involves an estimated 40 people with EBS.

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The trial enrolled adults and children ages 4 and older at two U.S. sites: one in Illinois and one in California. Participants were randomly assigned to receive either BM-3103 or a placebo for two months, after which all are given BM-3103 for two months.

BM-3103 gel applied directly onto patients’ fragile skin

The main goal, according to researchers, is to watch for changes in the area of blistered skin over 2-4 months of treatment with the topical gel, applied daily.

“The TAMES-02 study represents an important opportunity to further evaluate a potential therapeutic option for this patient population,” said Amy S. Paller, MD, an investigator and professor at Northwestern University in Chicago, which is running the study together with Stanford University. “We are encouraged by the continued progress of the program and its recognition by the FDA.”

Epidermolysis bullosa causes the skin to become extremely fragile, making it tear or blister easily. In epidermolysis bullosa simplex, this is caused by mutations in the KRT5 or KRT14 gene, which prevent keratin proteins from forming strong networks in the outer layer of the skin. Symptoms range from blisters limited to the hands and feet to widespread blistering and other manifestations all over the body.

The FDA’s fast track designation for BM-3103 highlights the importance of advancing promising investigational therapies and underscores the urgent need for innovation in rare genetic disorders that manifest in the skin.

BM-3103 is a gel applied directly onto the skin. It was developed using Bioendics’ liquid crystal MTORX technology, which works by removing mutated keratin proteins and degrading and recycling keratin aggregates, which are abnormal clusters of keratin proteins that fail to form normal, healthy networks. Its use is expected to ease symptoms of epidermolysis bullosa.

“Families affected by EBS face daily challenges that can profoundly impact quality of life,” said Brett Kopelan, executive director of DEBRA of America. “The FDA’s fast track designation for BM-3103 highlights the importance of advancing promising investigational therapies and underscores the urgent need for innovation in rare genetic disorders that manifest in the skin.”

BM-3103 already has orphan drug and rare pediatric disease designations from the FDA, both of which encourage development of treatments for rare diseases through incentives. The rare pediatric disease designation focuses on serious or life-threatening rare diseases primarily affecting children, and it may lead to a voucher for priority review of another treatment.