The ImmuPharma PLC (LON: IMM) share price surged 26.2% after issuing a further update about its Lupuzor™ (P140) program in patients with systemic lupus erythematosus (SLE). The company noted that it had submitted a phase 2/3 clinical trial protocol to the US Food and Drug Administration (FDA).
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In addition, the company confirmed that the submitted protocol contained significant changes compared to the phase 3 clinical trial it had already conducted. The most crucial changes were in the dosage levels, where the company will now use much higher dosages of Lupuzor™ than in the past.
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Investors cheered the news because the FDA submission brought the company closer to starting the phase 2/3 clinical trial. The company has requested a Type C meeting with the FDA, whose date the FDA will confirm within 21 days from the submission date.
Once the Type C meeting happens, the FDA will have a 75-day window to approve the new trial if all its conditions have been met. ImmuPharma intends to change the dosing method during the Phase 2/3 clinical trial from a subcutaneous injection to an intravenous injection to achieve higher levels of Lupuzor™ (P140) in the blood vessels.
ImmuPharma has partnered with Avion Pharmaceuticals and will conduct the phase 2/3 clinical trial together. The study will be a one-protocol pivotal study, allowing the two firms to explore a wide dosing range for Lupuzor™, having already established a clean safety profile for the drug.
Tim McCarthy, ImmuPharma’s CEO, said: “We are extremely pleased to be moving positively forward with the Lupuzor™ program. Avion and ourselves believe that the new design of the Phase 2/3 adaptive study offers the greatest probability of a successful result for the overall benefit of Lupus patients. We remain on track to commence the trial in H2 2023.”
Art Deas, Avion’s CEO, said: “We remain committed to our full support of ImmuPharma, and with insights gained from last year's PK study and invaluable guidance from the FDA, we believe we have submitted the most robust clinical protocol for Lupuzor™.”
Investors should watch ImmuPharma’s subsequent announcements to monitor Lupuzor™’s progress.
*This is not investment advice.
ImmuPharma share price.
The ImmuPharma share price surged 26.23% to trade at 2.31p, from Friday’s closing price of 1.83p.
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