Effimune obtains regulatory approval for Phase I clinical trial in humans of its new immunomodulator FR104

Effimune announced today that it had received the authorization from the Belgian regulatory authority, the FAMHP (Federal Agency for Medicines and Health Products) for a Phase I clinical trial of FR104, its drug candidate for controlling the regulation of the immune system.

This double-blind randomized clinical trial will take place on 70 healthy volunteers (both men and women) over a period of 9 months, and will prepare the future development of FR104 in rheumatoid arthritis and kidney transplantation. The primary objectives of the trial are to establish the safety and tolerability of FR104 and assess its pharmacodynamics and pharmacokinetics. Since September 2013, FR104 has been under a global license agreement with Janssen Biotech, Inc., a subsidiary of Johnson & Johnson.

Bernard Vanhove, CEO of Effimune said:

The excellent preclinical results obtained with the FR104 confirms its huge potential in controlling the immune system, and our partnership with Janssen Biotech Inc., has favored the transfer of the product to the clinic. We are confident in the development of our drug candidate that provides a real hope for the treatment of people suffering from rheumatoid arthritis and of transplanted patients.

The FAMHP, Belgian equivalent of ANSM in France and, is the competent authority for regulating the quality, safety and efficacy of medicines and other health products in Belgium. It ensures, in the interests of public health, the quality, safety and efficacy of drugs and health products during clinical development and launch. The trial’s full title is "Randomized, double-blind, placebo-controlled, dose-escalation study for the assessment of safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of single and multiple ascending intravenous doses in healthy subjects of FR104"

The FR104 is a new drug candidate fruit of Effimune’s research and based on academic studies carried out in collaboration with INSERM. It is protected by a US patent number 8785604. FR104 is a monoclonal antibody fragment, a specific antagonist of CD28, a central element in the signaling pathway of T-lymphocytes. FR104 blocks, in a targeted manner, the destructive function of effector T-cells but not the function of the regulatory T-cells, thus promoting immune tolerance.