BioSenic files for additional patent protection following new clinical evidence of efficacy for JTA-004 in osteoarthritis
23 Janeiro 2024 - 3:00AM
BioSenic files for additional patent protection following new
clinical evidence of efficacy for JTA-004 in osteoarthritis
PRESS RELEASE – INSIDE INFORMATION
Following a post-hoc analysis of a Phase
3 trial demonstrating pain relief in patients with severe knee
osteoarthritis, Biosenic applied for an international patent to
support the newly focused indication of JTA-004.
Mont-Saint-Guibert, Belgium, January 23,
2024, 7.00am CET – BioSenic
(Euronext Brussels and Paris: BIOS), the
clinical-stage company focused on serious autoimmune and
inflammatory diseases and cell therapy, today announces the filing
of a U.S. patent for JTA-004, a viscosupplement in late-stage
clinical development, following new evidence of its efficacy in a
recently defined subtype of osteoarthritis (OA).
There are several types of OA. In 2022, outside
investigators publishedi findings that defined three subtypes based
on biomarkers – including a severe form marked by high levels of
pain, of certain biomarkers and persistent and progressive
inflammation. Using this new approach to stratifying disease,
BioSenic commissioned a post hoc analysis of a phase 3 trial for
JTA-004 that had showed inconclusive results for patients with knee
OA. By instead focusing on patients in their study with the severe
inflammatory subtype, the analysis detected pain-relieving efficacy
superior to both placebo and the active comparator.
Given the promising new findings, BioSenic now
intends to expand patent protection for "Hyaluronic acid-based
compositions and related methods for use in the treatment of
osteoarthritis in specifically selected subjects." The rights were
initially acquired from Bone Therapeutics following a reverse
merger with Medsenic SAS to form BioSenic. As BioSenic develops a
new clinical plan, this position will support steps toward
commercializing JTA-004 for patients experiencing severe pain from
knee OA.
JTA-004 differs from other hyaluronic acid-based
products for OA in its inclusion of clonidine, an alpha-2
adrenergic inhibitor, as an active pharmacological component. Its
analgesic properties have been known for decades, and more recent
data has demonstrated prolonged local anti-inflammatory activity,
as well as a normalizing effect on cell differentiation of
chondrocytes. New findings publishedii this month in Nature further
connect chondrocytes to degeneration in knee OA, providing further
potential explanation for JTA-004’s positive clinical results in
reducing symptoms of pain and inflammation in severe cases.
Prof. François Rieger, PhD, Chairman and
Chief Executive Officer of BioSenic said: "Given the
exciting new findings in knee osteoarthritis, it is time to build
on previous efforts to develop JTA-004 to control the most severe
subtype of progressive knee osteoarthritis. As further clinical
work is needed to fully establish the significant benefits expected
from JTA-004, our IP position will provide significant protection
as we explore partnerships to bring this important asset to a very
large pharmacological market. We are dedicated to improving the
lives of millions of patients continue to suffer from this
often-debilitating disease.”
iAngelini F, et al. Ann Rheum Dis Feb 2022iiFu
W, et al. Nature Jan 2024
About BioSenic
BioSenic is a biotech company specializing in
the development of clinical assets issued from: (i) the arsenic
trioxide (ATO) platform (with key target indications including
Graft-versus-Host Disease (GvHD), systemic lupus erythematosus
(SLE) and systemic sclerosis (SSc) and (ii), the development of
innovative products to meet unmet needs in immune and autoimmune
diseases. Following a reverse merger in October 2022, BioSenic
combined its strategic positioning and key strengths to develop,
separately and in combination, an entirely new arsenal of various
anti-inflammatory and anti-autoimmune formulations using the
immunomodulatory properties of ATO/oral ATO (OATO) with its
innovative cell therapy platform and strong IP for tissue repair
protection.
BioSenic is based in the Louvain-la-Neuve
Science Park in Mont-Saint-Guibert, Belgium. Further information is
available on the website at http://www.biosenic.com.
About BioSenic 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 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). BioSenic has
been successful in a phase 2 trial with its intravenous
formulation, 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) in
an early phase 2a study. Systemic sclerosis is also part of the
clinical pipeline of 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.
- ALLOB, 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
stromal cells from healthy donors into bone-forming cells on the
site of injury. After phase 2 clinical results with contradictory
conclusions, BioSenic is now focusing on determining the best time
to optimise the efficacy of ALLOB (between early or late
treatment).
The company is currently focusing its present
R&D and clinical activities on a selective, accelerated
development of its autoimmune (ATO/OATO) platform.
For further information, please
contact:
BioSenic SAFrançois Rieger, PhD,
Chief Executive OfficerTel: +33 (0)671 73 31
59investorrelations@biosenic.com
International Media Enquiries:IB
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Investor
Enquiries:Seitosei ●
ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11
22 ghislaine.gasparetto@seitosei-actifin.com
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