BioSenic presents new Phase 3 data on JTA-004 to treat severe
osteoarthritis pain at the 2024 OARSI World Congress
PRESS RELEASE
BioSenic presents new Phase 3 data on
JTA-004 to treat severe osteoarthritis pain at the 2024 OARSI World
Congress
Using a recently published approach to
stratify patients with knee osteoarthritis, an external post hoc
analysis of Phase 3 data showed JTA-004 is safe and efficient for
treating pain symptoms in the most severely affected
patients.
Mont-Saint-Guibert, Belgium, January 25
2024, 7.00 am CET – BioSenic
(Euronext Brussels and Paris: BIOS), the
clinical-stage company specializing in serious autoimmune and
inflammatory diseases and cell therapy, will for the first time
share post hoc data on its late-clinical asset JTA-004 at the
Osteoarthritis Research Society International (OARSI) World
Congress 2024. The post hoc analysis of a Phase 3 study found that
a single injection of JTA-004 was safe and efficacious for patients
with a newly characterized severe inflammatory subtype of knee
osteoarthritis (OA). The data will be presented by Yves Henrotin,
Ph.D, a professor at University of Liège in Belgium
(musculoSKeletal Innovative research Lab, mSKIL), Center for
Interdisciplinary Research on Medicine, CIRM), as well as Founder
and the Chairman of the Board of Artialis, which performed the
analysis.
JTA-004 is an innovative intra-articular
viscosupplement treatment for knee OA, composed of hyaluronic acid,
plasmatic proteins, and clonidine. The post-hoc analysis addresses
different subpopulations of OA patients in the data of a Phase 3
trial (KOA-2) completed in 2019. The trial was intended to
demonstrate that treatment with JTA-004 leads to a reduction in
knee pain intensity compared to saline solution or Synvisc-One®,
three months after injection, in subjects suffering from
symptomatic knee OA.
The initial results in a broad pool including
patients with several subtypes were inconclusive. However, BioSenic
was inspired to reevaluate the previous data following the
publication of a study1 that identified biomarkers to
stratify OA phenotypes, including a disease subtype characterized
by systemic inflammation and the most severe symptoms. The
conclusion of the post hoc analysis is that JTA-004 is safe and
effective for successfully treating symptoms in this
inflammatory-driven subgroup.
François Rieger, Ph.D, President of
the Board and CEO of the BioSenic Group, said:
“We thank Prof. Henrotin, a renowned specialist, and his team
of biostatisticians for this collaboration. This new, detailed
analysis demonstrates the positive therapeutic effect of JTA-004 in
severe OA, and it will enable a more specific approach to the
unsolved problem of efficient pharmacological treatment of
osteoarthritis pain.”
“OARSI is dedicated solely to advancing OA
research. It brings together KOLs and renowned researchers from
around the world to facilitate the translation of knowledge about
OA, a debilitating disease that affects about 528 million people
worldwide and rising sharply. With more than 30 years of experience
serving the OA community, OARSI provides the necessary framework,
expert resources, and support for its international members to
address the challenges of OA so that the knowledge gained can
ultimately be used to improve patient care and outcomes,”
said Carole Nicco, Ph.D, BioSenic Chief Scientific Officer
and Chief Operating Officer. “We are pleased to share
our findings at the Congress and hope that these data will support
the further evaluation of our viscosupplement, which has all the
characteristics to treat severe inflammatory OA and address an
unmet medical need.”
BioSenic recently filed an additional patent
application to support further development of JTA-004 for severe
OA.
“A single intra-articular injection of JTA-004
is safe and efficient for treating symptoms in the most severely
affected knee osteoarthritis (OA) patients – a multicenter,
randomized, double-blind, placebo-and active-treatment controlled
phase 3 clinical trial” will be presented at OARSI World Congress
2024, held April 18-21 in Vienna, Austria.
1 Angelini F, et al. Ann Rheum Dis
Feb 2022
About BioSenic
BioSenic is a biotech company specializing
in the clinical development of autoimmune disease therapies.
Following a reverse merger in October 2022, BioSenic combined its
strategic positioning, key strengths and strong IP to develop
products along two tracks, separately and in combination. The first
platform leverages immunomodulatory properties of arsenic trioxide
(ATO) for an entirely new arsenal of formulations, including oral
delivery (OATO), for anti-inflammatory and anti-autoimmune
indications such as chronic graft-versus-host disease (cGvHD),
systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). In
parallel, BioSenic develops innovative products through a second
platform that includes cell therapies and strong IP protection for
tissue repair technologies.
BioSenic is based in the Louvain-la-Neuve
Science Park in Mont-Saint-Guibert, Belgium. Further information is
available at http://www.biosenic.com.
About BioSenic's technology
platforms
The ATO
platform has immunomodulatory properties with
fundamental effects on the activated cells of the immune system.
One direct application is its use in autoimmunity to treat in its
chronic, established stage. Chronic GvHD is one of the most common
and clinically significant complications affecting long-term
survival of allogeneic hematopoietic stem cell transplantation
(allo-HSCT), a curative treatment for patients with serious blood
diseases, including cancers.
BioSenic’s intravenous ATO formulation,
Arscimed®, has orphan drug
designation status by FDA and EMA, and it has shown good safety and
significant clinical efficacy for skin, mucosae, and the
gastrointestinal tract in an early Phase 2a study. The company is
planning a confirmatory international Phase 3 study with its oral
ATO (OATO) formulation. OATO
will also target moderate-to-severe forms of SLE. BioSenic is also
developing a new IP-protected OATO formulation for the treatment of
SSc, a serious chronic disease that affects skin, lungs or
vascularization, and has no current effective treatment.
Preclinical studies on pertinent animal models support the launch
of a Phase 2 clinical trial.
ALLOB is an
allogeneic cell therapy platform made of differentiated, bone
marrow-sourced mesenchymal stromal cells (MSCs), which can be
stored at the point-of-use in hospitals. ALLOB represents a unique
and proprietary approach to organ repair, and specifically to bone
regeneration, by turning undifferentiated MSCs from healthy donors
into bone-forming cells at the site of injury. BioSenic is studying
the results of a Phase 2 trial to optimise the efficacy of ALLOB by
determining the best timing for therapeutic intervention and
seeking partners to continue the development of the promising
underlying therapy strategies.
The company is also exploring partnerships
at all levels for its JTA-004
viscosupplement for a severe inflammatory subtype of
osteoarthritis, following a positive post hoc analysis of Phase 3
data demonstrating safety and efficacy in support of this
licensing.
For further information, please
contact:
BioSenic SA
François Rieger, PhD, CEO
Tel: +33 (0)671 73 31 59
investorrelations@biosenic.com
International Media Enquiries:
IB Communications
Michelle Boxall
Tel: +44 (0)20 8943 4685
michelle@ibcomms.agency
For French Investor Enquiries:
Seitosei ● Actifin
Ghislaine Gasparetto
Tel: +33 (0)1 56 88 11 22
ghislaine.gasparetto@seitosei-actifin.com
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