DGAP-News

NEOVACS ANNOUNCES TOP LINE PHASE IIB CLINICAL TRIAL RESULTS OF TNF-KINOID IN RHEUMATOID ARTHRITIS

DGAP-News: Neovacs S.A. / Key word(s): Study results
NEOVACS ANNOUNCES TOP LINE PHASE IIB CLINICAL TRIAL RESULTS OF
TNF-KINOID IN RHEUMATOID ARTHRITIS

16.12.2014 / 07:30

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PRESS RELEASE

NEOVACS ANNOUNCES TOP LINE PHASE IIB CLINICAL TRIAL RESULTS OF TNF-KINOID
IN RHEUMATOID ARTHRITIS

AND UPDATE ON CLINICAL PROGRAMS

- Phase IIb clinical trial of TNF-Kinoid in Rheumatoid Arthritis
confirmed the good safety profile as well as antibody production, but
failed to meet efficacy endpoints. Further evaluation is ongoing.

- Clinical studies of IFNα-Kinoid in lupus to be initiated mid 2015 in
Europe, Latin America and Asia, and early 2016 in the U.S.; Preclinical
development programs to proceed as planned

- Financial agreement with Kepler Cheuvreux of up to EUR20 million
extends operating capital beyond 2015

Paris, December 16, 2014 - NEOVACS (Alternext Paris: ALNEV), a leader in
active immunotherapies for the treatment of autoimmune diseases, today
announced top line data on the Phase IIb clinical trial of TNF-Kinoid in
Rheumatoid Arthritis (RA).

This trial confirmed the immunogenicity and good tolerance of TNF-Kinoid
with no safety issues, but did not meet its primary efficacy endpoint.

"We are disappointed that our TNF-Kinoid Phase IIb study did not have a
positive outcome, given the potential benefits that this new approach would
have brought to patients suffering from RA.
We are in the process of analyzing the data in depth to understand the lack
of clinical efficacy for TNF-Kinoid in this trial and to discuss potential
next steps with Neovacs Scientific Advisory Board and with our prospective
partners. These findings will determine future developments of TNF-Kinoid
within our portfolio," said Miguel Sieler, Neovacs CEO.

"As we analyze these data, we will focus our research efforts and resources
on the clinical development of IFNα-Kinoid in lupus, a disease that affects
over six million people worldwide, and for which no fully effective
biological treatment currently exists."

TNF-Kinoid Phase IIb trial in Rheumatoid Arthritis fails to meet primary
endpoint

In 2014, Neovacs completed a randomized, double-blind, placebo-controlled,
multicenter 140-patients Phase IIb clinical trial of TNF-Kinoid in RA. The
co-primary endpoints for the study were based on the DAS28-CRP and ACR 20
scores - measures commonly used in clinical trials for RA.

The study confirmed the safety and tolerability of the product. An
independent Data Safety and Monitoring Board had previously issued positive
assessments on safety in January and March 2014.