Neovacs announces completion of patient recruitment for its phase IIB clinical study in the l…

Perspective for the publication of clinical results in the second quarter of 2018

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Paris and Boston, June 20, 2017 – 07: 00 CEST – NEOVACS (Alternext Paris : ALNEV), a leader in immunotherapy active for the treatment of autoimmune diseases, announced today the completion of recruitment of patients for its clinical study of IFN-K-002, phase IIb clinical trial with the IFNalpha-Kinoid in the treatment of lupus.

“The completion of the recruitment is an important milestone for our clinical development program with the IFNalpha-Kinoid : it confirms the interest of the clinicians involved in this trial for our therapeutic approach innovative,” said Thérèse Croughs, Chief Medical Officer of Neovacs. “We are now awaiting the results of the study in the second quarter of 2018. ”

178 patients with systemic lupus erythematosus active, moderate-to-severe, were enrolled in this phase IIb clinical trial (study IFN-K-002). This study, randomized versus Placebo, multicentric and international conduct under IND [1], is currently taking place in Europe, Asia, North Africa, South America and the United States. All patients is in the course of treatment and the duration of follow-up in the main study is 9 months.

Neovacs has designed this phase IIb clinical trial, according to the assessment criteria, robust, and scientifically established, whose objectives are to obtain data that is relevant and meaningful :

Biological efficiency : measured by the reduction of the signature interferon, one of the markers of the main activity of the disease.
Clinical effectiveness : measured by the response to the score BICLA [2] at the 9 month. This score is one of the indices of reference validated by the health authorities, to assess the clinical response in the clinical studies targeting lupus.

The company has put in place an effective strategy, promoting the dynamics of the recruitment of eligible patients in this phase IIb clinical trial in lupus, a complex disease, and rare on a global scale, with a number of patients in the world, estimated at 5 million [3].

In order to ensure the validity of the clinical results of this study, Neovacs is now surrounded by 3 committees of experts : (1) the Committee independent data monitoring of security ” iDSMB [4] “, whose missions are related to the assessment of the safe use of the vaccine, 2) a “Committee of adjudication independent” : in order to assess the consistency of the data of the clinical response to the vaccine (BICLA) and finally, 3) a “Steering Committee”, to oversee the proper conduct of the clinical trial as well as the operational aspects.

About the Kinoid technology® developed by Neovacs
It is for the treatment of pathologies associated with an overproduction of a cytokine and endogenous to the origin of auto immune disorders or certain cancers. This technology is immunotherapy active and is based on the generation of an immune response that produces antibodies through the administration of a complex immunogenic associating the cytokine targeted to a protein carrier. Intramuscular injection of the Kinoid at the patient will be able to induce the immune response and stimulate the production of polyclonal antibodies directed against the cytokine target. It is thus possible to block the overproduction of the cytokine and its pharmacological effects. Several auto-immune diseases and inflammatory conditions (systemic lupus erythematosus, dermatomyositis, type 1 diabetes, …) are characterized by a disruption of the functioning of cytokines, which are produced in excess. In the case of the cytokine IFNalpha, its overproduction is going to encourage inflammation and the dysregulation of immunity.

About the lupus
Systemic Lupus Erythematosus (sle) or systemic Lupus Erythematosus (sle) is an autoimmune disease, severe, chronic and catastrophic, the causes of which remain unknown. This progressive disease is marked by a succession of flare-ups and is accompanied by a deterioration of the general condition and periods of remission (symptom-free). The causes are multiple, it seems that there is some genetic predisposition can play a role in the onset of the disease. Among the triggers are the environmental factors, hormonal and immunological (autoimmune ” self-tolerance “). In fact, the first seizure usually occurs at the end of a particular event (stress, sun exposure, pregnancy, viral infections, medications, etc.). It is preceded by an asymptomatic phase that can last for several years, during which patients develop autoantibodies. Lupus can affect many organs and tissues (skin, kidneys, joints, heart, lungs, nervous system…) and manifested by clinical signs heterogeneous (rashes, arthritis, photosensitivity, renal impairment, neurological disorders, anemia…), which vary from one person to another and change during the course of the disease. The prevalence stands at between 1 in 1000 and 1 to 3000. The disease affects mainly women (9 women/ 1 man) and starts mostly between 15 and 45 years of age. In France the number of patients is estimated at between 30 000 and 60 000.

About Neovacs
Listed on Alternext Paris since 2010, Neovacs has become a major player in the therapeutic vaccines targeting the treatment of auto-immune diseases, inflammation, and certain cancers. Thanks to its innovative technology inducing an immune response, polyclonal, protected potentially until 2032 by 5 families of patents, Neovacs is focusing its development efforts clinic on IFNalpha-Kinoid for the treatment of lupus and dermatomyositis. Neovacs has also been performing preclinical work on other therapeutic vaccines for the treatment of autoimmune diseases, cancers, allergies and type 1 diabetes. The ambition of this approach “Kinoid” is to allow patients to better endure a life-long treatment, which would be more effective, well-tolerated and very flexible in its administration. Neovacs is eligible for the plan (PEA-PME.
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