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FDA gives ImmuPharma go-ahead for pharmacokinetic study
12th Aug 2021 13:02
(Sharecast News) - Specialist drug discovery and development company ImmuPharma said on Thursday that the United States Food and Drug Administration (FDA) has approved the start of the pharmacokinetic study as part of its new, "optimised" international phase 3 trial of 'Lupuzor'.
The AIM-traded firm said the pharmacokinetic (PK) study is a phase 1 study to assess the presence of Lupuzor in the body after administration of a single dose.
It said the study would be carried out in a total of up to 24 healthy male subjects, and depending on the timing of patient recruitment, it was expecting the study to take between eight and 12 weeks to complete from commencement.
Preparations would be made to begin the phase 3 study following completion of the PK study, the board explained.
For the continued late-stage programme development, ImmuPharma and Avion Pharmaceuticals, as part of a joint steering committee, had agreed on a collaborative group consisting of a board of 'key opinion leaders', and a "leading" medical patient advocacy group.
Collectively the network, due to its knowledge of the lupus disease and its access to lupus patient groups, would be "invaluable" to the successful outcome of the phase 3 trial, ImmuPharma said.
"We are extremely pleased to see the next positive steps for Lupuzor, with continued positive dialogue with the FDA, their approval to commence the PK study and an agreed clinical and regulatory pathway over the next period," said chairman and chief executive officer Tim McCarthy.
"We look forward to providing further progress updates on the PK study and ultimately moving Lupuzor forward into the optimised phase 3 study, on the successful completion of the PK study."
At 1245 BST, shares in ImmuPharma were down 2.55% at 8.4p.
The AIM-traded firm said the pharmacokinetic (PK) study is a phase 1 study to assess the presence of Lupuzor in the body after administration of a single dose.
It said the study would be carried out in a total of up to 24 healthy male subjects, and depending on the timing of patient recruitment, it was expecting the study to take between eight and 12 weeks to complete from commencement.
Preparations would be made to begin the phase 3 study following completion of the PK study, the board explained.
For the continued late-stage programme development, ImmuPharma and Avion Pharmaceuticals, as part of a joint steering committee, had agreed on a collaborative group consisting of a board of 'key opinion leaders', and a "leading" medical patient advocacy group.
Collectively the network, due to its knowledge of the lupus disease and its access to lupus patient groups, would be "invaluable" to the successful outcome of the phase 3 trial, ImmuPharma said.
"We are extremely pleased to see the next positive steps for Lupuzor, with continued positive dialogue with the FDA, their approval to commence the PK study and an agreed clinical and regulatory pathway over the next period," said chairman and chief executive officer Tim McCarthy.
"We look forward to providing further progress updates on the PK study and ultimately moving Lupuzor forward into the optimised phase 3 study, on the successful completion of the PK study."
At 1245 BST, shares in ImmuPharma were down 2.55% at 8.4p.