CRO Simbec-Orion lands Phase III lupus trial with fast-tracked compound

23-Jan-2015 - Last updated on 07-Nov-2023 at 11:12 GMT

ImmuPharma and the recently formed CRO Simbec-Orion Group have entered into a collaboration to run a Phase III clinical study of the potential lupus treatment Lupuzor. Financial terms of the agreement were not released.

Lupuzor (also known as Rigerimod, IPP-201101 and P140) is ImmuPharma’s lead compound for the treatment of Lupus, a chronic, potentially life-threatening autoimmune disease. Lupuzor has been granted fast track status by the US FDA and approved to start Phase III trials under a Special Protocol Assessment (SPA) due to its strong safety and efficacy profile, the companies said.

The 52-week multi-centre study will commence immediately and will recruit patients in between four and eight European countries, as well as the US, a Simbec-Orion spokesman told Outsourcing-Pharma.com. According to the Alliance for Lupus Research, 1.5m people have Lupus in the US.

Simbec-Orion, a full service international CRO specialising in rare orphan conditions, has previously completed Phase II and III lupus trials, the spokesman added.

The clinical study is a last step prior to the filing of the drug for approval with the US FDA and the EMA.

Dimitri Dimitriou, CEO of ImmuPharma said: "This deal is very attractive for ImmuPharma because it allows us to retain rights to Lupuzor until commercialisation. This opens many options for the Company for further corporate deals including following in the path of all ‘big biotechs’ by generating our own sales. We are delighted to have chosen to work with Simbec-Orion for a number of key clinical and commercial reasons. We are confident in their abilities and credentials and particularly appreciate their investment and commitment to Lupuzor’ssuccess."

Simbec-Orion moves

Simbec-Orion was created in 2014 after the merger of Simbec, a specialty CRO in early stage development, and Orion Clinical Services, a specialty CRO in late stage development, for £12.5m ($21m).

Simbec-Orion has agreed that it will reinvest a significant proportion of its fees from the ImmuPharma trial in new ordinary shares at a fixed price of 150p per share, representing a premium of 206% to the closing price on January 21. It is expected that over the duration of the study Simbec-Orion will subscribe for approximately 900,000 new ordinary shares.

The merger was completed through the provision of funds raised from the Wales Life Sciences Fund, managed by Christopher Evans’ Arthurian Life Sciences Limited. The CRO has annual revenues of about £25m ($37.6m) and employs nearly 250 staff with operations across Europe, Australia and the US.