BioSenic presents successful preclinical data on its ATO medication
for controlling key symptoms at the 2024 Systemic Sclerosis World
Congress
PRESS RELEASE
- Preclinical data in a
transgenic mouse model shows beneficial effects on various clinical
symptoms analogous to those observed in human systemic
sclerosis.
- Findings may further support
future clinical program.
Mont-Saint-Guibert, Belgium, 20 March
2024, 7.00am CET – BioSenic
(Euronext Brussels and Paris: BIOS), the
clinical-stage company specializing in serious autoimmune and
inflammatory diseases and cell therapy, presented the latest data
on arsenic trioxide (ATO) for systemic sclerosis (SSc) at the
8th Systemic Sclerosis World Congress 2024. The data,
obtained with the laboratory of Yannick Allanore, MD, Ph.D. from
the Hospital Cochin, builds additional evidence for the use of ATO
in multiple autoimmune conditions, as observed in various animal
models and in recent pilot human clinical trials.
The scientific communication presented by Anne
Cauvet and Pr. Allanore demonstrated the efficacy of ATO in Fra2
transgenic mice, which is used as a disease model of symptomatic
SSc, a chronic autoimmune disease marked by multi-organ fibrosis.
BioSenic has previously showed that ATO, a first-in-class specific
immunomodulatory drug, has significant therapeutic action in
humans, and the company is progressing several formulations for
autoimmune diseases in clinical trials. The researchers further
reported that ATO resulted in significant lung histological
changes, a trend towards a decrease in various fibrotic makers and
a strong reduction in vascular remodeling in the SSc mouse model.
The mechanism of action of ATO appears to involve a marked
counteraction of the immune activation characteristic of SSc,
particularly Tcell involvement. These positive findings have
encouraged BioSenic to continue studying ATO for potential use in
SSc.
François Rieger, PhD, President of
the Board and CEO of the BioSenic Group, said:
“Our past data, including several animal models of autoimmune
diseases and recent Phase 2 trials in systemic lupus erythematosus
and chronic graft-versus-host-disease, have shown the remarkable
therapeutic benefits of BioSenic’s liquid ATO solution for various
autoimmune conditions with critical unmet medical needs. The more
recent data for another serious autoimmune disease, systemic
sclerosis, has given convincing preclinical evidence to support a
Phase 2 trial for patients affected by this disease, which has no
cure. The well-known safety of ATO’s pharmacologically active
ingredient mean derived products, including an oral formulation
(OATO), may follow FDA’s rapid 505(b)(2) regulatory path.”
Understanding the mechanisms of action of
arsenic on target cells is essential to determine the best
conditions of use and possibly optimal combinations with other
drugs. The work of several research teams worldwide has highlighted
the autoimmunity-regulating, anti-fibrotic and vascular remodeling
properties of arsenic, with potential to treat the lethal lesions
in SSc and other autoimmune pathologies.
Dr. Carole Nicco, BioSenic’s CSO and
COO, said: "We are pleased to highlight these
results, which complement previous findings in another preclinical
model of non-genetic but induced-SSc. All our preclinical data,
taken together, provide a coherent picture of the significant
therapeutic effect we can expect in human patients suffering from
severe chronic autoimmune diseases with unmet medical needs."
The results were presented at the 8th
Systemic Sclerosis World Congress last week in Prague, Czech
Republic.
About BioSenic
BioSenic is a leading biotech company
specializing in the development of clinical assets issued
from its Medsenic’s arsenic trioxide (ATO) platform. Key target
indications for the autoimmune platform include
graft-versus-host-disease (GvHD), systemic lupus erythematosus
(SLE), and now systemic sclerosis (SSc).
Following the merger in October 2022, BioSenic combined the
strategic positionings and strengths of Medsenic and Bone
Therapeutics. The merger specifically enables
Medsenic/Biosenic to develop an entirely new arsenal of various
anti-inflammatory and anti-autoimmune formulations using the
immunomodulatory properties of ATO/oral ATO (OATO).
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 the main Medsenic/BioSenic
technology platform
The ATO
platform provides derived active products with
immunomodulatory properties and fundamental effects on the
activated cells of the immune system. One direct application is its
use in onco-immunology to treat GvHD (Graft-versus-Host Disease) in
its chronic, established stage. cGvHD is one of the most common and
clinically significant complications affecting long-term survival
of allogeneic hematopoietic stem cell transplantation
(allo-HSCT).
Medsenic has been successful in a phase 2
trial with its intravenous formulation,
Arscimed®, which has orphan
drug designation status by FDA and EMA. The company is heading
towards an international phase 3 confirmatory study, with its new,
IP-protected, OATO formulation. Another selected target is
moderate-to-severe forms of systemic lupus erythematosus (SLE),
using the same oral formulation. ATO has shown good safety and
significant clinical efficacy on several affected organs (skin,
mucosae, and the gastrointestinal tract). Systemic sclerosis is now
full part of the clinical pipeline of Medsenic/BioSenic. This
serious chronic disease badly affects skin, lungs, or
vascularization, and has no current effective treatment.
Preclinical studies on pertinent animal models are positive, giving
good grounds to launch a phase 2 clinical protocol, using new
immunomodulatory formulations of APIs recognized to be active on
the immune system.
The company is currently focusing its
present R&D and clinical activities on a selective, accelerated
development of its autoimmune platform.
Note: The allogeneic cell therapy
platform-originating from the previous listed company Bone
Therapeutics company, may be of renewed interest by using isolated
and purified differentiated bone marrow Mesenchymal Stromal Cells
(MSCs) as a starting material for further isolation of passive or
active biological subcellular elements. Indeed, these cells may
provide new subcellular vesicles potentially able to deliver a
unique and proprietary approach to organ repair. BioSenic is now
involved in determining new patentable approaches in this complex
area of cell therapy.
For further information, please
contact:
BioSenic SA
François Rieger, PhD, Chief Executive Officer
Tel: +33 (0)671 73 31 59
investorrelations@biosenic.com
International Media Enquiries:
IB Communications
Neil Hunter / Michelle Boxall
Tel: +44 (0)20 8943 4685
neil.hunter@ibcomms.agency / 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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