Lipella Pharma reports positive results from phase 2a trial of LP-10 for haemorrhagic cystitisn

Lipella Pharmaceuticals Inc., a clinical-stage biotechnology company, announced top line results of the company's recently completed phase 2a clinical trial evaluating the safety and efficacy of its drug candidate LP-10 for haemorrhagic cystitis, a rare but highly morbid disease for which there are currently no FDA approved treatments. Jonathan Kaufman, chief executive officer, presented a corporate overview including the top-line results, at Biotech Showcase 2023 on Wednesday, January 11th at 2:00pm PST at the Hilton San Francisco - Union Square, 333 O'Farrell Street, San Francisco, California. "The successful completion of the phase 2a clinical trial of LP-10 is a critical milestone in Lipella's development," said Jonathan Kaufman, Ph.D., chief executive officer of Lipella. "We're gratified with the results and look forward to our next step, which will be to communicate with the FDA on the study's results and the pathway forward to seeking regulatory approval for LP-10. The achievement of this milestone brings Lipella one step closer to providing a first-in class treatment for the cancer survivor community with haemorrhagic cystitis." The LP-10 phase 2a clinical trial was a multi-center, dose-escalation study (clinicaltrials.gov: NCT01393223). The study recruited 13 subjects with moderate to severe refractory haemorrhagic cystitis. These subjects were treated with up to two courses of LP-10 intravesical bladder instillations. The top line results indicated: All subjects tolerated LP-10 instillations and completed the study without report of product related serious adverse events; LP-10 pharmacokinetic analysis demonstrated short duration of systemic uptake; A dose response was noted and there were; Decreased haematuria: Decreased cystoscopic bleeding and ulceration sites; Improved patients' urinary symptoms. Responder analysis noted complete response in 3 subjects, partial response in 7 subjects and no response in 3 subjects. Lipella received Orphan Disease Designation LP-10 for the treatment of moderate to severe haemorrhagic cystitis, a disease with great unmet need and no currently approved drug treatment. Radiation used to treat prostate, colon, uterine, cervical and other pelvic cancers can cause chronic, painful urinary inflammation and blood loss called radiation haemorrhagic cystitis. Certain chemotherapies (such as cyclophosphamide) can also cause this painful form of urinary bleeding. The blood loss associated with haemorrhagic cystitis can lead to surgery and can be fatal. Lipella is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications

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