BioSenic releases new in-depth analysis of its positive phase 2 clinical data for optimal administration scheme for its next late-stage trial of arsenic trioxide (ATO) targeting cGvHD
18 Juillet 2024 - 7:00AM
UK Regulatory
BioSenic releases new in-depth analysis of its positive phase 2
clinical data for optimal administration scheme for its next
late-stage trial of arsenic trioxide (ATO) targeting cGvHD
Press Release
The upcoming Phase 3 trial with ATO is
more robust following a new post-hoc analysis.
Mont-Saint-Guibert, Belgium, July 18,
2024, 7.00 am CEST – BIOSENIC (Euronext
Brussels and Paris: BIOS), the clinical-stage company specializing
in serious autoimmune and inflammatory diseases therapy, today
announced the final results of a new, detailed post-hoc analysis of
the Company's previous Phase 2 clinical trial of ATO for the
first-line curative treatment of cGvHD. The analysis will be used
to determine the optimal posology of therapeutic oral ATO
administration for BioSenic's upcoming clinical trial(s) and will
be submitted for peer review prior to preparation of the necessary
regulatory filings for trial approvals.
Medsenic's first phase 2 clinical trial,
entitled "Treatment of Chronic Graft Versus Host Disease With
Arsenic Trioxide (GvHD-ATO)", was conducted from 2016 to 2020
(ClinicalTrials.gov ID NCT02966301 - GMED16-001). Medsenic's global
results were originally published in 2022 in the peer-reviewed
journal Transplantation and Cellular Therapy under the title "High
Response Rate and Corticosteroid Sparing with Arsenic
Trioxide-Based First-Line Therapy in Chronic Graft-versus-Host
Disease after Allogeneic Hematopoietic Stem Cell Transplantation".
These results demonstrated that the first-line combination of ATO
and corticosteroids (CS) with or without a calcineurin inhibitor
(cyclosporine) is associated with a high clinical response rate and
rapid CS sparing in moderate to severe cGVHD following allogeneic
hematopoietic stem cell transplantation (HSCT), the current
standard of care for several types of leukemia. The primary
endpoint of the Phase 2 study was preliminary efficacy based on the
overall response rate (ORR; complete response [CR] or partial
response [PR]) at 6 months after 1 or 2 cycles of 4-week treatment.
At 6 months, the ORR was 75.0%, with a CR rate of 35% and a PR rate
of 40%.
BioSenic's new in-depth post-hoc clinical analysis
of the Phase 2 clinical data now shows that in the group of
patients who did not respond after first so-called induction cycle,
more patients (20%) responded after a consolidation cycle of
treatment. As a result, BioSenic will continue to use this 2-cycle,
time-limited regimen. This will consist of a double four-week
course. In addition, BioSenic has determined that an increase in
the number of weekly injections over a four-week course could
significantly increase the positive effect of the treatment on the
biological and cellular parameters of the disease, consistent with
a full effect of the drug at levels determined to be very safe for
patients. BioSenic's goal is to finally select the best conditions
for administering effective and safe doses of arsenic trioxide to
achieve a convincing curative treatment of cGvHD, for which there
is currently no alternative effective long-term therapy.
In the field of oncology, intravenous (IV) ATO
has been accepted as a first-line treatment for acute promyelocytic
leukemia (APL) since 2002, with demonstrated safety and long-term
remissions. Until now, ATO in APL has been administered daily by IV
infusion for up to or more than one hundred cumulative doses. IV
administration requires hospitalization, is inconvenient for
patients, results in reduced quality of life and is expensive. The
anticipated introduction of an oral formulation of ATO in 2 cycles
of four full weeks each, corresponding to an optimal dosing
regimen, will significantly improve patient quality of life and
compliance while reducing healthcare costs. This will be the next
achievement in BioSenic's broader goal to contribute improved and
potentially curative treatments for an autoimmune disease for which
there are currently no satisfactory medical solutions.
François Rieger, PhD, Chairman and CEO,
BioSenic said: "BioSenic's early preclinical and
current clinical data show that the first-in-class modulatory
properties of arsenic trioxide for immune cells differentiation and
homeostatic maintenance of the immune system are much broader and
deeper than previously anticipated. The systematic and renewed
analysis of BioSenic's key clinical results in the treatment of
cGvHD is providing additional insights into the optimization of its
formulations, dosages and optimal treatment timing, in line with
new basic research on the drug's mechanisms of action. We are now
able to propose definitive conditions for the optimal use of
arsenic trioxide for an upcoming pivotal Phase 3 trial of our ATO
formulation for chronic Graft-versus-Host disease. "
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, CEO
Tel: +33 (0)671 73 31 59
investorrelations@biosenic.com
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