TAMES-02 Trial of TolaSure Gel Nears Interim Readout in Epidermolysis Bullosa Simplex

Karen McGuire, PhD, chief executive officer and co-founder of BioMendics, recently spoke with Dermatology Times from the debra Care Conference in Los Angeles, California, about epidermolysis bullosa simplex (EBS) and the development of TolaSure Gel. McGuire detailed the phase 2 TAMES-02 trial (NCT07027345) of TolaSure, which is enrolling patients at Northwestern University with Amy Paller, MD, and at Stanford University with Joyce Tang, MD.¹ McGuire also outlined recent protocol changes, a new primary end point, and steps taken to reduce the burden of trial participation.

In a previous interview, McGuire discussed TolaSure’s fast track designation² and what that means for its development timeline.

TAMES-02 Enrollment and Interim Readout Timeline

According to McGuire, the trial is actively enrolling patients toward an interim readout. Investigators are nearing the 20 patients needed for the interim data evaluation. Enrollment will continue toward a 40-patient phase 2 target or until the decision is made to advance to phase 3.

"We're really getting close to that 20 patients that we need to do that interim data evaluation," McGuire said. "We will continue to enroll patients right until either we decide to move on to phase 3, or we hit that 40 subject goal for phase 2."

McGuire said she hopes to complete the readout and have data available by the end of the year.

Expanded Eligibility and New Localized EBS Cohort

Protocol changes now allow enrollment of patients aged 2 years and older with autosomal dominant KRT5 or KRT14 mutations classified as intermediate or severe. A new cohort has been added for patients with localized EBS, a population McGuire said has had limited access to clinical trials despite foot blistering affecting mobility, schooling and work.

"These patients historically have had very few opportunities to participate in clinical treatments, even though the blistering on their feet can really significantly impact life, mobility, being able to school, work," McGuire said. "We're really excited to see how the drug performs in these patients, so we can build a broader cohort of patients for phase 3."

Longitudinal Blister Burden as the Primary End Point

The trial's primary end point is longitudinal blister burden, tracked across a larger body surface area with weekly imaging. McGuire said the approach better captures new blister formation over time, since EBS is a dynamic disease. Patient-reported outcomes including pain, itch, quality of life and foot function are also assessed.

"EBS is a very dynamic disease. The blister you measure Monday is not the blister you're probably measuring on Friday," McGuire said.

Reducing the Burden of Trial Participation

On-site visits have been reduced to 3, with telemedicine used for assessments in between. Patients receive at-home devices to photograph their skin, and imaging is standardized through partner collaborations for quality control. The trial is also enrolling internationally, with travel support provided to reduce geography as a barrier to participation.

"We've worked hard to reduce the burden of participating in this trial," McGuire said.

McGuire said the current focus remains straightforward: complete a rigorous phase 2 study and let the data guide the design of the phase 3 pivotal trial.

References

1. About clinical trials. BioMendics. Accessed August 5, 2026. https://biomendics.com/index.php/patients-caregivers/about-clinical-trials
2. BioMendics receives FDA Fast Track Designation for BM-3103 (TolaSure Gel) for epidermolysis bullosa simplex. News release. Business Wire. June 23, 2026. Accessed August 11, 2026. https://www.businesswire.com/news/home/20260623529098/en/BioMendics-Receives-FDA-Fast-Track-Designation-for-BM-3103-TolaSure-Gel-for-Epidermolysis-Bullosa-Simplex