ImmuPharma updates plan for trials of lupus treatment Lupuzor

The AIM-traded firm said that, following approval from the US Food and Drug Administration (FDA) of the protocol for the pharmacokinetic study and local ethics committee approval, it had been working with its US partner Avion Pharmaceuticals and its contract research organisation Simbec-Orion, together with additional specialist service providers, to prepare for the start of the study.

As part of the regulatory process, the Investigational Medicinal Product Dossier (IMPD) required “significant” revision, due to the inclusion of a new proprietary synthesis of P140, which ImmuPharma said provided greater intellectual property protection and a lower cost of goods.

The new IMPD was submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) and, following a full review, the MHRA approved the start of the pharmacokinetic study.

The company described the pharmacokinetic study as 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 volunteers.

Volunteers had been selected and approved, with dosing to start on 15 February.

As it had previously said, ImmuPharma said it expected study results to be available around the end of the first quarter of 2022.

“We are extremely pleased to see this next positive step for Lupuzor, with approval from the MHRA to commence the pharmacokinetic study,” said chief executive officer Tim McCarthy.

“We look forward to moving Lupuzor forward into the optimised phase 3 study, in collaboration with our partner Avion, on the successful completion of the pharmacokinetic study.

“The study is on track to deliver results around the end of the first quarter of 2022.”

Dr Tim Franklin, chief operating officer, added that the company’s biotechnology team in Bordeaux was “looking forward” to the near-term completion of the pharmacokinetic study.

“Our contract research organisation, Simbec-Orion, and other key collaborators including professor Sylviane Muller, have provided invaluable contributions in completing a robust and improved IMPD to the MHRA.

“We look forward with Avion to moving Lupuzor forward and in parallel, we will continue to focus on unlocking further value through the other indications within the P140 platform and the anti-infective programmes.”

At 1235 GMT, shares in ImmuPharma were down 3.31% at 7p.