UK-based companies ImmuPharma and Simbec-Orion Group have entered into a collaboration agreement to execute ImmuPharma’s pivotal Phase III clinical trial of its lead compound Lupuzor to treat Lupus, a chronic, potentially life-threatening autoimmune disease.
Lupuzor (also called as Rigerimod, IPP-201101 and P140) has secured fast track designation from the US Food and Drug Administration (FDA) as well as approval to initiate Phase III trials under a Special Protocol Assessment (SPA) due to its strong safety and efficacy profile.
The multi-centre Phase III trial will start immediately and will enrol patients across Europe, the US and other regions.
The 52-week, randomised, double-blind, parallel-group, placebo-controlled trial will evaluate the efficacy and safety of a 200mcg dose of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.
The trial is designed to show the safety and efficacy of IPP-201101 and as a last step prior to the filing of the drug for approval with the FDA and the European Medicines Agency (EMA).
ImmuPharma chief executive officer Dimitri Dimitriou 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’s success."
Simbec-Orion is a full service international Clinical Research Organisation (CRO) that specialises in Rare & Orphan conditions and also has previous direct experience in conducting Lupus trials.
The organisation was created through the merger between Simbec Research, a specialist CRO in early stage clinical development, and Orion Clinical Services, the specialist CRO in late stage clinical development.