ImmuPharma announces successful results from its phase I clinical trial with IPP-201101 for Lupus
- Phase II to start soon -
10th May. ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, announced today that it has successfully completed the placebo-controlled phase I study involving 24 healthy volunteers of its lead compound IPP-201101 for Lupus, a chronic, life-threatening autoimmune disease.
This study, which took place in France, was the first administration in humans for IPP-201101 and was designed to assess its safety and tolerability. The preliminary safety report confirmed that the drug was safe and well-tolerated.
These encouraging results have allowed ImmuPharma to proceed with a phase II proof-of-concept and efficacy study in Lupus patients in Europe. The phase II study protocol was recently approved by the ethics committees and has been filed with the appropriate regulatory authorities. The dosing of Lupus patients in this study is expected to start soon and the trial will measure recognised surrogate markers of clinical efficacy, in preparation of the pivotal phase III studies.
To that effect, ImmuPharma has also scheduled a meeting with the FDA to design the appropriate development programme to get market authorisation of the drug in the US.
Dr Robert Zimmer, President and Chief Scientific Officer of ImmuPharma, said: 'IPP-201101, which has blockbuster potential, is a novel concept for the treatment of Lupus. IPP-201101 modulates the signalling of CD4+ cells and may also interact with the T-reg pathway. The key element is that IPP-201101 has been designed to interact only with the CD4+ cells linked to Lupus and leaves intact the remaining immune system, allowing Lupus patients to be protected by a fully operational immune system unlike the currently used therapies such as high dose corticoids and immunosuppressants. When administered appropriately it has the potential to stop the progression of the disease and should therefore be prescribed as early as possible during the course of the Lupus disease. The already available preclinical package demonstrating efficacy and selectivity for Lupus together with the good results of the phase I safety and tolerability study in man are critical in this respect and may offer clear benefit for the patients when compared to the current therapies.' |