The Lipella Pharmaceuticals Inc (NASDAQ: LIPO) stock price soared 68.9% after completing the Phase 2a clinical trial evaluating the safety and efficacy of its LP-10 drug candidate for treating hemorrhagic cystitis.
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Investors cheered the news, given that the US Food and Drug Administration (FDA) had awarded LP-10 Orphan Disease Designation for treating hemorrhagic cystitis, a potentially fatal disease with significant unmet need since there is no currently approved drug treatment.
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Lipella’s multi-centre, dose-escalation Phase 2A clinical trial recruited 13 subjects with moderate to severe refractory hemorrhagic cystitis. The participants were treated with up to two courses of LP-10 through intravesical bladder instillations.
All the participants tolerated the LP-10 doses and completed the study without reporting any severe side effects related to the treatment. The drug’s pharmacokinetic analysis showed it was quickly absorbed into the patient’s system.
Lipella Intends to present the study results as a late-breaking presentation at the American Urological Association (AUA) Annual Meeting in Chicago on April 30, 2023.
The company noted decreased cystoscopic bleeding, decreased hematuria, and improved patients’ urinary symptoms and ulceration sites among the different dose responses. The firm has received complete responses from three participants and a partial response from seven, and no responses from three participants.
Dr Jason Hafron, the trial’s Principal Investigator, noted: “Patients were able to tolerate LP-10, and the treatment response is fast. Having a safe and effective drug to treat hemorrhagic cystitis would be a major service to the field of urology.”
Jonathan Kaufman, PhD, Lipella Pharma’s CEO, stated: “The successful completion of the clinical trial of LP-10 is a critical milestone in Lipella's development. This milestone takes us one step closer to bringing a first-in-class treatment for the cancer survivor community with hemorrhagic cystitis.”
Dr Michael Chancellor, M.D., Lipella’s Chief Medical Officer, said: “Lipella's next step will be to communicate with the FDA on the study results and pathway toward seeking regulatory approval for LP-10.”
*This is not investment advice.
The Lipella Pharma (LIPO) stock price.
The Lipella Pharma (LIPO) stock price rallied 68.85% to trade at $3.09, rising from Wednesday’s closing price of $1.83.
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