Neovacs announces the full results of its Phase IIb Clinical study of IFNalpha Kinoid in lupus - 13th International Lupus Con...
April 09 2019 - 12:30AM
Neovacs announces the full results of its Phase IIb Clinical study
of IFNalpha Kinoid in lupus - 13th International Lupus Congress
2019
PRESS RELEASE ·
PRESS RELEASE · PRESS
RELEASE
NEOVACS
ANNOUNCES THE FULL RESULTS OF ITSPHASE IIb
CLINICAL STUDY OF IFNα
KINOID IN LUPUS,
PRESENTED AT THE 13th INTERNATIONAL LUPUS CONGRESS
2019
Paris and Boston, April 9, 2019, 7:30 am
CEST – NEOVACS (Euronext Growth Paris: ALNEV) leader in
active immunotherapy for the treatment of auto-immune and
inflammatory diseases, announced that the full results of the phase
IIb clinical study were presented on April 6, 2019, by Prof.
Frédéric Houssiau, MD, PhD, Vice-Rector of the Faculty of Health
Sciences at UCL (Université Catholique de Louvain), Brussels,
Belgium,1 and chairman of the clinical study, at the first plenary
of the international congress on Systemic Lupus
Erythematosus, LUPUS 2019 (San Francisco, 5-8 April),
during an oral session entitled: “IFN Kinoid in Systemic Lupus
Erythematosus (SLE): Results from a Phase IIb, Randomized,
Placebo-Controlled Study 2”.
The results confirmed that treatment
with IFN-alpha Kinoid induced a
strong immune response: 91.4% of treated patients produce
neutralising polyclonal antibodies against interferon alpha.
Prof. Frédéric Houssiau
commented: “A significant biological effect on the
interferon signature was observed in treated patients
during the phase IIb study of IFNα Kinoid in lupus. Although the
clinical response was not based on a modification of the BICLA
score3at 36 weeks, encouraging clinical results were seen on the
SRI score (4), combined with corticosteroid reduction, as well as a
statistically significant clinical result on the LLDAS
endpoint.” 4
“According to the world’s lupus experts, this
LLDAS endpoint may become the main criteria to assess disease
activity and response to treatment when submitting applications to
regulatory agencies. In addition, this study showed a reduction of
corticosteroid therapy, which may eventually lead to a major
breakthrough, as it could improve the patients’ quality of life
considerably by eliminating the adverse effects of
corticosteroids,” continued Prof. Frédéric Houssiau.
This study also showed:
- A statistical trend observed on the SRI-4 clinical score,5 with
corticosteroid reduction to ≤5 or 7.5 mg/day (p=0.07), which became
statistically significant (p=0.04) in the
subgroup of patients who developed neutralising antibodies
against interferon alpha;
- A statistically significant clinical
response (p=0.0022) based on the
LLDAS score, with 52.9% responders in the treated group,
versus 29.8% in the placebo group, i.e. a 23%
difference;
- A marked difference in corticosteroid intake,
i.e. 7.1 mg in the placebo group, versus 5.4 mg in the group of
patients treated with IFNα Kinoid, at 36 weeks;
- A statistical trend on the improvement
of fatigue in patients treated with
IFN-alpha Kinoid
(p=0.068). Fatigue is frequently reported in
most chronic conditions. It affects almost 9 in 10 lupus patients.
When lupus is active, fatigue is directly associated with the
disease;
- Good tolerance of IFNα
Kinoid. Serious adverse effects were more frequent
in the placebo group (13%) than in the group treated with IFN-K
(7%). Moreover, frequency and severity of non-serious adverse
events were not different in both groups. The main adverse effects
reported during the study were mostly related to the disease and to
a local reaction at the injection site. The treatment with
IFN-alpha Kinoid did not modify or worsen the risk of infection
associated with lupus.
All these highly encouraging results must be
assessed further in a phase III clinical program.
About the 13th international lupus
congressThe 13th International Congress on Systemic Lupus
Erythematosus (LUPUS 2019) is proud to invite you to San Francisco,
California USA, April 5-8, 2019. This exciting meeting, “LUPUS:
Gateway to the Future” will highlight advances and insights from
recent SLE research into the causes and outcomes of SLE, explore
the promise of implementing a personalized approach to diagnosis,
prognosis, and treatment, and provide a forum to hear exciting and
innovative research from a new generation of investigators. The
Congress will span the disciplines dedicated to improving outcomes
in SLE, from basic and translational science through epidemiology
and outcomes research.
http://lupus2019sf.org/
About the Phase IIb study with IFNα Kinoid in the
treatment of 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 IFNα Kinoid. Patients were
randomized to receive either IFNα 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 ≤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 IFNα
Kinoid.
About NeovacsListed 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 IFNα-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 auto-immune 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
Contacts
NéovacsCorporate
Communication& Investor
RelationsCharlène Masson+33 1 53 10 93
00cmasson@neovacs.com |
Press Relations – NewCapAnnie-Florence
Loyer+33 (0)6 88 20 35 59 +33 (0)1 44 71 00
12afloyer@newcap.frLéa JacquinTel : +33(0)1
44 71 20 41ljacquin@newcap.fr |
Orphéon FinanceFinancial Communication and
Investor RelationsJames Palmer+33 7 60 92
77 74j.palmer@orpheonfinance.com |
1 Prof. Frédéric Houssiau, MD, PhD, Vice-Rector
of the Faculty of Health Sciences at UCL (Université Catholique de
Louvain), Brussels, Belgium, and tenured professor at UCL,[1] and
formerly Head of the Department of Rheumatology of the St-Luc
University Teaching Hospital (Brussels, Belgium), and founding
member of the lupus research network.
2 The abstract presented is available on the
Company’s website: http://www.neovacs.fr/en/
3 BICLA: BILAG-based Composite Lupus
Assessment
4 LLDAS: Lupus Low Disease Activity State
5 SRI: Composite Systemic Lupus Erythematosus
(SLE) Responder Index 4 with corticosteroid reduction to
≤5mg/day.
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