Palvella Reveals 3.9% QTORIN™ Rapamycin Gel Phase 3 SELVA Success and Porokeratosis Study
Palvella showcased QTORIN™ 3.9% rapamycin gel in two posters, highlighting Phase 3 SELVA success in microcystic lymphatic malformation with mLM-IGA improvement (p<0.001) and systemic levels under 2 ng/mL. A porokeratosis study of ten patients uncovered major physical, psychosocial and cancer burdens, supporting Phase 2 QTORIN™ pitavastatin trial in H2 2026.
1. QTORIN™ Rapamycin Gel Poster and Phase 3 SELVA Data
Palvella presented Poster #76954 at the American Academy of Dermatology meeting, detailing development of QTORIN™ 3.9% rapamycin anhydrous gel designed to prevent crystallization and optimize skin penetration. The poster highlighted Phase 3 SELVA trial results in microcystic lymphatic malformations with statistically significant mLM-IGA improvement (p<0.001) and systemic rapamycin levels below 2 ng/mL, confirming strong efficacy and tolerability.
2. Porokeratosis Burden Qualitative Study
Poster #76929 reported on ten in-depth interviews (nine patients, one caregiver) assessing the impact of porokeratosis. Interviewees described persistent pre-cancerous, pruritic lesions, reported up to 16% malignant transformation risk, experienced physical limitations, social isolation and anxiety, and highlighted substantial daily and psychosocial challenges.
3. Upcoming Pipeline Milestones
Palvella is advancing its QTORIN™ pipeline with a Phase 2 trial of pitavastatin for disseminated superficial actinic porokeratosis scheduled for the second half of 2026. The company also expects to announce a fourth clinical indication for QTORIN™ rapamycin in H2 2026, reinforcing its focus on rare skin diseases and vascular malformations without FDA-approved therapies.