Palvella Therapeutics’ QTORIN™ Rapamycin Gel: A Potential Game-Changer for Microcystic Lymphatic Malformations
At the 15th World Congress of Pediatric Dermatology in Buenos Aires, Argentina, Dr. Amy Paller, a renowned dermatologist, presented the latest developments in the SELVA trial, focusing on the potential of Palvella Therapeutics’ QTORIN™ rapamycin 3.9% anhydrous gel for treating microcystic lymphatic malformations (microcystic LMs).
Phase 2 Results and the Design of the Ongoing Phase 3 SELVA Trial
During her presentation, Dr. Paller reviewed the clinically and statistically significant Phase 2 results of the SELVA trial. These results demonstrated the safety and efficacy of QTORIN™ rapamycin in treating microcystic LMs, leading to the expansion of the Phase 3 SELVA trial to include children aged 3 to 5 years old.
Expanding the Reach of the SELVA Trial
The Phase 3 SELVA trial is a randomized, double-blind, placebo-controlled study designed to assess the safety, efficacy, and durability of QTORIN™ rapamycin in treating microcystic LMs in children and adults. The trial is expected to enroll approximately 120 patients across multiple centers in the United States and Europe.
Top-Line Results on Track for the First Quarter of 2026
Top-line results from the SELVA trial are on track for the first quarter of 2026, and if successful, QTORIN™ rapamycin could become the first approved therapy and standard of care for microcystic LMs in the U.S.
Impact on Individuals and the World
For individuals with microcystic LMs, the potential approval of QTORIN™ rapamycin could mean a significant improvement in their quality of life. These rare, often disfiguring skin conditions can cause physical discomfort, emotional distress, and social isolation. An FDA-approved therapy would provide hope and effective treatment options for those suffering from these conditions.
On a larger scale, the approval of QTORIN™ rapamycin could lead to a paradigm shift in the way rare genetic skin diseases are treated and perceived. It could pave the way for further research and development of treatments for other rare conditions, ultimately improving the lives of countless individuals around the world.
Conclusion
The ongoing SELVA trial represents a promising step forward in the development of an FDA-approved therapy for microcystic lymphatic malformations. With top-line results expected in the first quarter of 2026, the potential approval of QTORIN™ rapamycin could significantly improve the lives of those affected by this rare condition, while also inspiring continued research and innovation in the field of rare genetic skin diseases.
- Palvella Therapeutics’ QTORIN™ rapamycin 3.9% anhydrous gel is being studied for the treatment of microcystic lymphatic malformations.
- Dr. Amy Paller presented the latest developments in the SELVA trial at the 15th World Congress of Pediatric Dermatology.
- Phase 2 results demonstrated the safety and efficacy of QTORIN™ rapamycin, leading to the expansion of the Phase 3 SELVA trial to include children aged 3 to 5 years old.
- Top-line results from the SELVA trial are expected in the first quarter of 2026.
- If successful, QTORIN™ rapamycin could become the first approved therapy and standard of care for microcystic LMs in the U.S.
- Approval of QTORIN™ rapamycin could significantly improve the lives of those affected by this rare condition and inspire continued research and innovation in the field of rare genetic skin diseases.
