ImmuPharma and Avion to proceed with Lupuzor phase 3 trial

Specialist drug discovery and development company ImmuPharma updated the market on its activities with Avion Pharmaceuticals on Thursday, following the licence and development agreement it signed with Avion in November for the exclusive rights to ‘Lupuzor’ in North America.

The AIM-traded firm said the first joint steering committee was completed in December, in a bid to identify and agree the optimised phase 3 study design for Lupuzor, including a focus on those patients presenting with the biomarker anti-dsDNA autoantibody positive.

Confirmation that the committee wished to progress Lupuzor into its second international phase 3 clinical trial as soon as possible this year was received.

Avion and ImmuPharma were set to meet with the US Food and Drug Administration (FDA) in the first quarter, to discuss guidance on a new optimised international phase 3 trial protocol.

Positive discussions were also said to be ongoing with a number of potential commercial partners of Lupuzor outside of the United States.

“We are delighted with the positive and proactive progress made since entering into this partnership with Avion in November last year. Both companies are focused on expediting Lupuzor into a new optimised international phase 3 study as soon as possible this year after discussions with the FDA over the next period,” said ImmuPharma’s chief executive officer Dimitri Dimitriou and its president and chief scientific officer Robert Zimmer in a joint statement.

“In parallel, we have entered into positive discussions with a number of potential commercial partners for Lupuzor outside of the US.

“We are in a new chapter within ImmuPharma's history, with the investment thesis for the company and specifically Lupuzor being repositioned and we look forward to providing further updates on progress with shareholders over the next period.”

Art Deas, chief executive officer of Avion Pharmaceuticals, added that his company was “extremely pleased” with the partnership with ImmuPharma.

“We believe that Lupuzor has a unique position within lupus that sets it apart from competition, and we are delighted to be extending our footprint within this therapeutic area.

“We are committed on moving Lupuzor into a new phase 3 trial as quickly as possible this year.

“We look forward to continuing to make successful strides in the relationship with ImmuPharma going forward.”

At 1443 GMT, shares in ImmuPharma were down 10% at 13.5p.