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NEOVACS ANNOUNCES THE RESULTS OF ITS PHASE IIB STUDY FOR IFNalpha KINOID IN THE TREATMENT OF LUPUS WHICH ALLOWS TO PROCEED
WITH THE CLINICAL DEVELOPMENT INTO PHASE III
THE BIOLOGICAL OBJECTIVE AND THREE OUT OF FOUR CLINICAL OBJECTIVES WERE MET:
- Highly statistically significant efficacy in reduction of interferon signature
- Lack of statistically significant clinical efficacy measured by BICLA score
- Statistical trend on clinical efficacy measured by SRI-4 with reduction of steroid less than or equal to 5mg/day
- Statistically significant clinical efficacy on the LLDAS score
- Favorable safety profile of IFNalpha Kinoid treatment
Paris and Boston, July 3, 2018 - 7:00 am CEST - Neovacs (Euronext Growth Paris: ALNEV), a leader in active immunotherapy for the treatment of autoimmune diseases, today announces the results of its Phase IIb clinical trial of IFNalpha Kinoid in patients with moderate to severe lupus (SLE).
The results show a very statistically significant biological efficacy of IFNalpha Kinoid (p <0.0001), measured by the decrease of the interferon signature at week 36 of the study. The clinical response in patients treated with IFNalpha Kinoid vs those treated with placebo measured by the BICLA score at week 36, did not achieve a statistical trend as defined in the primary objectives of the study.
"It is important to note the very marked effect of IFNalpha Kinoid on the LLDAS score, of which one of the 5 criteria is the reduction of steroid use," stressed Professor Frédéric Houssiau, Scientific Chairman of the study, Rheumatology Department, Saint-Luc Clinical Universities, Brussels, Belgium. It suggests that one must take into account the reduction of steroid therapy, an important goal of treatment. This study demonstrates, once again, the difficulties in choosing the primary clinical endpoint in SLE."
The main secondary endpoints for assessing clinical efficacy were:
- SRI-4 with steroid reduction less than or equal to 5 mg/day
- LLDAS (Lupus Low Disease Activity Score)
Measured in week 36, SRI-4 with a reduction of steroid to less than or equal to 5mg/day showed a statistical trend of 54.4% for treated patients vs. 39% in those treated with placebo (p = 0.07) and the LLDAS a statistically significant effect of 52.9% vs. 29.8% (p = 0.002). Both point in favor of IFNalpha Kinoid treatment, which coupled with a major reduction in steroid is an important therapeutic step forward.
IFNalpha Kinoid was well tolerated and serious adverse events were reported more frequently in the placebo group (12.9%) compared to the IFNalpha Kinoid treated group (6.6%).
"These results of clinical efficacy, in particular on two reference indices (SRI-4 with steroid reduction to less than or equal to 5 mg/day and LLDAS) which have been validated by international health authorities or medical community, authorise the further clinical development with these scores into phase III," said Thérèse Croughs MD, Chief Medical Officer of Neovacs. "We would like to express our thanks to the patients, the investigators and all those who contributed to this important Phase IIb trial of our therapeutic vaccine in lupus."
This double blind, randomized, placebo-controlled, multi-center, Phase IIb study enrolled 185 patients in Europe, Asia, the United States, North Africa, and Latin America with moderate to severe lupus. The primary endpoints for the trial were biological efficacy and clinical efficacy nine months after the first treatment with IFNalpha Kinoid. Patients were randomized to receive either IFNalpha Kinoid or placebo intramuscular 5 times: days 1, 7, and 28 and then at 3 and 6 months. Patients also received standard treatment with antimalarials, immunosuppressants and / or steroids, the latest were gradually decreased to a dose less than or equal to 5 mg of prednisolone equivalent / day by 24 weeks and remained stable until the 36th week. At the end of this primary evaluation period, patients entered a 5-year follow-up period to assess the safety as well as the long-term biological and clinical efficacy of IFNalpha Kinoid.
"We are very pleased with these results that will enable us to move into phase III within a partnering to be finalised, in line with the objectives announced previously," said Miguel Sieler Chief Executive Officer of Neovacs, adding, "We have achieved 4 major objectives in a complex autoimmune disease. These results confirm the relevance of our innovative therapeutic approach and strengthen the potential of Kinoid treatment. "
Neovacs plans to submit the full results of this study and present them at a future international scientific congress.
The U.S. Food and Drug Administration has already granted Fast Track Status for IFNalpha Kinoid in lupus to Neovacs.
Neovacs will hold a Webcast conference call today at 10:00 am CEST, log in via the following link: https://channel.royalcast.com/webcast/neovacsfr/20180703_2/
For more information, visit this phase IIb clinical study with IFNalpha Kinoid in the treatment of lupus: www.clinicaltrial.gov. (Identifier: NCT02665364)
Systemic lupus erythematosus (SLE) or lupus erythematosus is a debilitating, chronic autoimmune disease whose etiology remains unknown. SLE is characterized by a loss of tolerance of self-antigens, with the production of autoantibodies, especially antinuclear antibodies that attack healthy tissues and cause inflammatory reactions in different parts of the body. The disease can affect multiple organs (skin, kidneys, joints, heart, lungs, central nervous system, etc.) and is characterized by heterogeneous clinical signs (skin rashes, arthritis, photosensitivity, nephritis, neurological disorders, anemia, thrombocytopenia, etc.), which vary from one person to another and change during the progression of the disease. Systemic lupus erythematosus affects mostly women.
About IFNalpha Kinoide
Neovacs anti-IFNalpha therapy consists of patient immunization using Interferon alpha (IFNalpha) kinoid (IFNalpha Kinoid). IFNalpha Kinoid is a heterocomplex consisting of an inactivated IFNalpha coupled to a T-helper stimulating carrier protein, Keyhole Limpet Hemocyanin (KLH). IFN-K is emulsified with Montanide(TM) oily adjuvant that non-specifically stimulates cell-mediated immune (CMI) responses to antigens.
IFNalpha Kinoid elicits the production of neutralizing polyclonal antibodies directed against the excess IFNalpha, thus blocking its ability to activate the inflammatory cascade. The generation of polyclonal neutralizing antibodies against IFNalpha following the administration of IFNalpha Kinoid is relevant to diseases mediated by IFNalpha over-production, such as Systemic Lupus Erythematosus (SLE), Dermatomyositis (DM), Type I Diabetes (T1D) and Sjögren's Syndrome (SS).
Listed on Euronext Growth since 2010, Neovacs is today a leading biotechnology company focused on an active immunotherapy technology platform (Kinoids) with applications in autoimmune and/or inflammatory diseases. On the basis of the company's proprietary technology for inducing a polyclonal immune response (covered by four patent families that potentially run until 2032) Neovacs is focusing its clinical development efforts on IFNalpha-Kinoid, an immunotherapy being developed for the indication of lupus, dermatomyositis and also in preclinical trial for Type 1 diabetes. Neovacs is also conducting preclinical development works on other therapeutic vaccines in the fields of autoimmune diseases, oncology and allergies. The goal of the Kinoid approach is to enable patients to have access to safe treatments with efficacy that is sustained in these life-long diseases. www.neovacs.fr
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 BILAG-Based Composite Lupus Assessment score
 Systemic Lupus Erythematosus Responder Index-4 with a reduction at less than or equal to 5mg/day level of glucocorticoids less than or equal to 5mg/day
 Lupus Low Disease Activity State