Completed trials

Completed clincal trials:

A first in man Phase I study to investigate tolerability and safety of topical LTX-109 in healthy subjects (Study C08-109-01)

• • • Healthy volunteers
    • Phase I
    • 1, 2 and 5% LTX-109 3x daily for 5 days, placebo controlled
    • 3 x 6 subjects w/ intact skin, and 6 subjects with abraded skin (1%)

Safety conclusions
Application site reactions for 2% and 5% not significantly different from placebo. Negligible systemic uptake

Efficacy conclusions
No efficiency assessment performed.

A Phase I/IIa study to evaluate the safety, tolerability and efficacy of topical LTX-109 in subjects nasally colonized with methicillin-resistant/-sensitive Staphylococcus aureus (MRSA/MSSA; Study C10-109-02)
Clinicaltrials.gov

• • • Nasal decolonization with MSSA or MRSA
    • Phase I / IIa
    • 1, 2 and 5% LTX-109 3x daily for 3 days, placebo controlled
    • 3 x 6 subjects; 12 with MSSA and 6 with MRSA

Safety conclusions
Predominantly mild (95%) AEs, also moderate (4%). Two unrelated severe AE (1%). 2% and 5%
caused more itching and burning

Efficacy conclusions
Statistically significant treatment effect on Log CFU for 2% and 5% on day 3 and 4. Re-colonization
weeks 2, 5 and 9.

• • • Nasal decolonization with MSSA or MRSA
    • Phase I / IIa
    • 3% LTX-109 4x in a day, 2 hours between applications, placebo controlled
    • 15 subjects

Safety conclusions
4 applications once every 2 h of a high-viscosity gel containing 3 % w/w was safe and well-tolerated by the study subjects. 19 AEs reported and 10 were assessed as possibly related, 1 was assessed as probably related, and 8 were assessed as unlikely related to the IMP.

Efficacy conclusions
The largest bacterial eradication rate in the active treatment group was observed at 6 h after the start of treatment (eradication in 8 out of 11 subjects). Four (4) out of 11 subjects in the active treatment group had MSSA eradicated at the end of the study (Day 22).