TAMES-02 Trial Launches for EB Simplex Therapy

Image Credit: © DermNet

BioMendics announced today it has initiated the TAMES-02 clinical trial to evaluate the safety and efficacy of TolaSure, a novel topical treatment for patients with generalized intermediate to severe Epidermolysis Bullosa Simplex (EB Simplex). The multicenter, randomized, double-blind, placebo-controlled study aims to build on promising early data and address a long-standing therapeutic gap in EB Simplex care.¹

A New Approach for a Challenging Disease

EB Simplex is a rare, inherited blistering disorder affecting approximately 30,000 to 50,000 people globally. Characterized by skin fragility and recurrent, painful blister formation—especially on the hands and feet—EB Simplex has historically lacked disease-modifying therapies. Management has largely been limited to supportive wound care and infection control.

TolaSure is positioned to change that landscape. The therapy works by targeting mutant keratin proteins responsible for structural instability in the skin’s epidermis. By reinforcing fragile keratinocytes, TolaSure offers a new mechanism that directly addresses the root cause of blister formation.

“Our mission is to bring meaningful therapies to patients living with rare diseases like EB Simplex—conditions that have been overlooked for too long,” said Karen M. McGuire, PhD, CEO and founder of BioMendics, in a news release. “With TolaSure, we’re targeting the root cause of blistering by reinforcing fragile keratinocytes. The TAMES-02 trial is a critical step toward proving safety and efficacy.”

Clinical Trial Design and Goals

TAMES-02 is being conducted in partnership with Stanford University School of Medicine and Northwestern University Feinberg School of Medicine, both recognized leaders in dermatologic research. The trial is enrolling patients aged 4 and older with generalized intermediate to severe EB Simplex. It includes a 2-month double-blind, placebo-controlled phase, followed by a 2-month open-label phase where all participants will receive TolaSure. A subsequent 6-month follow-up period is designed to monitor longer-term outcomes.

The trial also allows treatment of plantar blistering—a highly disabling manifestation of EB Simplex that often limits mobility and quality of life.

“This trial is a vital next step,” said Amy Paller, MS, MD, principal investigator at Northwestern University, in the release. “The collaboration with BioMendics and Stanford enables us to rigorously evaluate this therapy and, hopefully, bring real progress to patients who have had limited options for far too long.”

Building on Earlier Success

TAMES-02 follows the initial success of the TAMES-01 trial, which demonstrated early signs of clinical benefit and safety in adult patients.² According to Joyce Teng, MD, PhD, principal investigator at Stanford University, the early data was promising:

“Our early studies with TolaSure showed meaningful reduction in blistering, which is incredibly encouraging for the EB Simplex community,” she said in the release. “Clinical research in rare skin diseases requires collaboration with companies like BioMendics and patient advocacy groups like debra of America to accelerate progress toward transformative therapies.”

Access and Inclusivity

Recognizing the geographic and logistical barriers facing many rare disease patients, BioMendics is taking additional steps to ensure broad access to the trial.

“We’re really excited to be able to cover travel costs to bring patients in from all over the United States and internationally,” said Aleesha McCormick, PhD, senior clinical research scientist at BioMendics. “Our study design also lets us recruit slightly less severe patients who may not have flared enough to be eligible for other clinical studies.”

This inclusive recruitment strategy expands trial access to more of the EB Simplex population, potentially allowing earlier intervention in the disease course.

Broader Implications

Beyond EB Simplex, BioMendics sees potential for TolaSure in other rare keratin-based skin conditions, such as pachyonychia congenita and epidermolytic ichthyosis. If TAMES-02 results are positive, the company plans to pursue strategic partnerships to accelerate regulatory approval and commercialization.

Enrollment Open

TAMES-02 is now enrolling participants at multiple academic sites. Interested clinicians and patients can learn more by visiting www.biomendics.com.

As the trial progresses, the dermatology community will be watching closely for results that could signal the arrival of the first disease-modifying treatment for EB Simplex—offering renewed hope for patients long underserved by traditional dermatologic therapies.

References

1. BioMendics launches TAMES-02 clinical trial for innovative epidermolysis bullosa simplex therapy. News release. BioMendics. Published August 7, 2025. Accessed August 8, 2025. https://www.businesswire.com/news/home/20250806145441/en/BioMendics-Launches-TAMES-02-Clinical-Trial-for-Innovative-Epidermolysis-Bullosa-Simplex-Therapy
2. Safety and efficacy of topical TolaSure targeting aggregated mutant keratin in severe epidermolysis bullosa simplex (TAMES). ClinicalTrials.gov. Identifier: NCT05062070. Updated September 11, 2023. Accessed August 8, 2025. https://clinicaltrials.gov/study/NCT05062070