Clinical Trials

BioMendics is actively recruiting for the TAMES-02 clinical study: A Phase II, Closed Label, Placebo Controlled, Randomized, Double-Blinded Clinical Trial to Evaluate the Efficacy and Safety of TolaSure Gel, 5% w/w Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex (TAMES-02), in collaboration with Stanford University School of Medicine’s Department of Dermatology and Northwestern Medicine Department of Dermatology. 

Click here for an approved flier on the TAMES-02 clinical trial. 

Have EB Simplex patients? Talk to us about becoming a future site and referring patients! 

Who should I contact? 
For participation in the clinical trial. 

Stanford Dermatology: Dr. Joyce Teng (Investigator) & Thomas Buschbacher, tbusch@stanford.edu 
Northwestern University: Dr. Amy Paller (Investigator) & Dr. Lydia Rabbaa Khabbaz, lydia.rabbaakhabbaz@northwestern.edu 

For interest in BioMendics or to collaborate on the clinical trial

BioMendics, LLC: Dr. Karen McGuire, PhD, CEO kmcguire@biomendics.com

Safety and Efficacy Information

Clinical Trials in EB Simplex Adults: 

Clinical Evidence (TAMES-01, NCT05062070)

Design: Phase I/IIa, within-patient randomized, 6 severe EBS adults

Treatment: TolaSure Gel 5% w/w vs. Vehicle, applied daily to matched TLAs (up to 10 weeks)

    Key Outcomes

    • Blister surface area reduction
      • Week 3: –93% (BM-3103) vs. –52% (Vehicle) (p<0.05)
      • Week 4: –96% (BM-3103) vs. –45% (Vehicle) (p<0.01)
      • Fewer new blisters observed from Week 2 onwards
    • Molecular disease correction
      • TEM imaging: loss of keratin aggregates, restored keratin filaments in treated lesions
    • Safety: No treatment-related SAEs or lab abnormalities. Well tolerated in all subjects.

    Human Clinical Trials: Phase I and Phase II acute wound healing clinical research trials in reported no deaths or serious adverse events in over 100 healthy volunteers. No patients discontinued use of TolaSure® during the studies, and any adverse events related to erythema or edema peripheral to the wound bed were attributed to the normal wound healing process and most likely a result of frequent bandage changes.

    Manufacturing: TolaSure® is manufactured as a gel, under current Good Manufacturing Practice standards, for topical use only and may be administered to wounded, healing, or intact skin. Gel excipients are on the U.S. Food and Drug Administration’s list of inactive ingredients and are generally regarded as safe. BM-3103 can be stored at room temperature or refrigerated temperature.

    Toxicology Studies in Animals: Evidence from toxicology studies (rodents and swine) completed under Good Laboratory Practice standards supports that BM-3103 is distributed in sufficient concentrations throughout the skin to have a pharmacological effect with limited absorption. Additionally, these studies revealed no clinically significant findings of local or systemic toxic effects after repeated topical application of BM-3103.

    Click here to access our social media platforms and sign up to receive emails about an upcoming Epidermolysis Bullosa Simplex Focus Group and TAMES-02 Clinical Trial updates.

    Learn more at clinicaltrials.gov.