Lipella Reports Successful Top Line Results in Phase 2a Study
Clinical-stage biotechnology company, Lipella Pharmaceuticals (LIPO) has released positive top line results from its Phase 2a clinical trial investigating a potential treatment for hemorrhagic cystitis.
The trial showed statistically significant safety and efficacy for Lipella’s drug candidate, LP-10. The company plans to communicate with the FDA on the study’s results and the pathway forward to seeking regulatory approval for LP-10.
- The clinical trial was a multi-center, dose-escalation study of 13 subjects with moderate to severe refractory hemorrhagic cystitis.
- All subjects tolerated LP-10 instillations and completed the study without report of product related serious adverse events.
- This milestone positions Lipella to potentially provide a first-in-class treatment for the cancer survivor community living with hemorrhagic cystitis.
- Hemorrhagic cystitis is a rare but highly morbid disease for which there are currently no FDA approved treatments.
- LP-10 peak annual revenue estimates in hemorrhagic cystitis exceed $1 billion.
- Radiation results in hemorrhagic cystitis for approximately 60,000 patients each year.
- LP-10 has been granted orphan drug designation by the FDA.
- Lipella has patent protection for LP-10 through 2034.
- Given the severity of hemorrhagic cystitis and the lack of adequate treatment, LP-10 will potentially be a candidate for multiple accelerated regulatory pathways.
Lipella is focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications.