Galatea is a Phase 2a clinical trial evaluating TP-04 (lotilaner gel, 2.0%) in papulopustular rosacea.

Tarsus Pharmaceuticals is launching Galatea, a Phase 2a clinical trial evaluating TP-04 (lotilaner gel, 2.0%) in papulopustular rosacea (PPR).

Lotilaner, the active component of TP-04, has proven effective in previous clinical trials to kill Demodex mites, the most common ectoparasite found on humans, and the company is now attempting to treat PPR by targeting the mites as a potential underlying cause of the chronic skin disease.  

TP-04 is a novel, anti-parasitic agent that paralyzes and kills mites and other parasites by selectively inhibiting parasite-specific GABA-CI channels.  

The trial will evaluate the safety, tolerability, and efficacy of TP-04 when applied topically to the faces of adult participants aged 18-59 with moderate to severe PPR; and will also measure the improvement in facial lesions over a 12-week treatment period. 

Data from a Phase 1 study of TP-04 demonstrated that it was well tolerated when topically applied to facial areas of healthy volunteers and safety data supports progression to Phase 2a.