ImmuPharma PLC (LON:IMM), the specialist drug discovery and development company has told DIrectorsTalk that registration with the U.S. National Institutes of Health – ClincialTrials.gov website has now gone ‘live’ confirming Lupuzor’s(TM) pivotal Phase III trial protocol and the current clinical commencement and completion of the study. Further details can be viewed at: ClincialTrials.gov.
ImmuPharma plc has also signed a Term Sheet with a US investor for a proposed private placement to fund the clinical trial. The initial instalment of funding consists of a convertible loan of US$2,000,000 plus additional capital of up to $12,000,000, at the Company’s discretion, subject to certain criteria, over a two year period. Further disclosure on the financial terms of this agreement will be announced following the signature of full agreement anticipated in the next few weeks.
Lupuzor(TM) (active name Rigerimod, also known as IPP-201101 and P140), is ImmuPharma’s lead compound for the treatment of Lupus, (Systemic Lupus Erythematosus or “SLE”), a chronic, potentially life-threatening autoimmune disease. Lupuzor(TM) 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. Simbec-Orion, a leading full service international Clinical Research Organisation specialising in Rare & Orphan conditions and with previous direct experience in Lupus trials, is conducting these trials. As part of the collaboration agreement with Simbec-Orion, as announced in January this year, it will invest a part of its internal invoiced costs in ordinary shares in ImmuPharma at a price of 150p. Furthermore, based on the French research tax credit (Crédit Impôt Recherche – CIR), ImmuPharma France will receive a tax return in the range of 25% of the incurred costs. The combination of the current funding mechanisms including the new US investor ‘Agreement’ should be sufficient to complete this current pivotal Phase III trial of Lupuzor(TM).
Since the commencement of work with Simbec-Orion, a number of key and necessary steps have been undertaken including detailed technical feasibility, site selection as well as completion of the regulatory process in each selected country where the trials will be conducted. Key European and US sites have now been identified and it is anticipated that about 15 sites in the US and 20 sites in Europe will be enrolled. Recruitment could be completed during the summer of 2016. Patient dosing is expected to commence this autumn.