ImmuPharma PLC on Monday said it submitted a phase 2/3 clinical trial protocol to the US Food & Drug Administration testing the Lupuzor treatment for lupus patients.
The London-based drug discovery and development company said the new design takes into account the FDA’s key guidance points from a previous ’Type C’ meeting alongside insights from its pharmacokinetic study completed last year.
This followed ImmuPharma and Avion Pharmaceuticals LLC agreeing in February on a phase 2/3 adaptive trial design for the next clinical design of Lupuzor.
ImmuPharma said the submitted protocol contains many changes from the design of the previous phase 3 clinical trial it carried out, including the level of dose being administered and the method of administration.
A Type C meeting with the FDA has been requested and it will update the market with the date of the meeting once confirmed by FDA, ImmuPharma said.
The phase 2/3 study remains on track to begin in the second half of 2023.
‘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,’ said ImmuPharma Chief Executive Officer Tim McCarthy.
Avion CEO Art Deas added: ‘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.’
Shares in ImmuPharma were up 17% to 2.13 pence each in London on Monday morning.
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