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.

A Phase II, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses of LTX-109 (1 % and 2 %) versus placebo in impetigo (Study C12-109-04)
Clinicaltrials.gov

• • • Gram-positive skin infection
    • Phase IIa
    • 1, 2 and 5% LTX-109 3x daily for 5 days, placebo controlled
    • 3 x 6 subjects

Safety conclusions
Adverse events (AEs) did not differ significantly between treatment groups. No AEs related to
treatment. Negligible systemic uptake in 2 of 18 patients

Efficacy conclusions
No indications that LTX-109 improved clinical cure. Bacteriological response was slightly better for
the patients treated with LTX-109. To pursue this clinical indication further treatment regimen
exploration is required.

A Phase IIa pilot study to evaluate the safety, tolerability and efficacy of LTX-109 in patients with uncomplicated, Gram-positive, skin infection (Study C10-109-03)
Clinicaltrials.gov

• • • Impetigo (non-bullous)
    • Phase IIa
    • 1 and 2% LTX-109 3x daily for 5 days, placebo controlled
    • 2 x 70 subjects enrolled; 51 and 60 subjects completed

Safety conclusions
LTX-109 safe and well tolerated. Only one AE (fever) was considered as possibly related to the study
drug.

Efficacy conclusions
Consistent trends, but no statistically significant differences, improvement for 1% and 2% dose group. Bacterial response unaffected. The study was one completed subject short of having statistically significant results on antibacterial efficacy. Furthermore, the low IMP concentrations
used (1 and 2%) were too low, and only early-stage impetigo patients should have been enrolled.

• • • 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).