BioSenic puts Phase IIb ALLOB trial on hold
INSIDE INFORMATION
Prior efficacy unmatched
but excellent safety profile confirmed, timing of ALLOB
administration for optimal bone repair to
be reevaluated
Mont-Saint-Guibert,
Belgium, June
19th
2023,
7.00
am CET –
BioSenic (Euronext Brussels and Paris:
BIOS), the clinical stage company specializing in serious
autoimmune and inflammatory diseases and bone and cartilage cell
repair, today announces the decision to suspend its interventional
trial on fracture healing, using the ex-Bone-Therapeutics lead
product, ALLOB. This decision follows negative results obtained for
the primary endpoint in the exploratory Phase IIb trial (ALLOB
IIb), which focused on safety and treatment timing efficacy.
The aim of this Phase IIb study was to evaluate
the efficacy of administering ALLOB (derived from mesenchymal stem
cells) a couple of days after a bone fracture to accelerate
fracture healing. In contrast to the previous successful Phase IIa,
where ALLOB was administered after 3.5 to 7 months, in 21 long bone
fractures with documented delayed- or non-union, early application
of ALLOB did not accelerate the fracture healing process.
Lieven Huysse, MD,
Chief
Medical
Officer of
BioSenic, further reports: “the current ALLOB
Phase IIb study in 57 patients (randomized 1:1 versus placebo) can
confirm the excellent safety profile of ALLOB injections, with no
reported serious adverse events related to the experimental
treatment”. The compilation of the two clinical studies and the
pre-clinical data also suggest that the administration of ALLOB, in
order to positively influence a complex bone repair process, should
be carried out outside the acute early post-traumatic inflammatory
period.
In short, ALLOB-treatment remains of potential
benefit as an add-on to standard of care, at the right time, to
improve recovery from extreme bone damage. This should be of great
help in either after trauma or after bone surgeries. After
difficult fractures, the rate of late non-union varies with
fracture location: tibia is the most likely to be affected by
non-union. Failure of bone fracture healing, the real target of our
cell repair therapy, occurs in 5% to 10% of all patients.
BioSenic's clinical activities will now focus on
its Phase III cGVHD trial with oral arsenic trioxide (OATO).
BioSenic, through the Medsenic company autoimmune disease platform
had completed a successful phase II trial targeting cGVHD (chronic
Graft vs Host Disease), with a demonstrated efficacy of more than
75% on the Full Study Population and 84% on the Per Protocol
Population. A phase III study is now in the starting blocks to
reach the market as quickly as possible, through the framework of
an expedite 505(b)(2) FDA regulatory pathway.
“BioSenic has chosen to focus resources on its
most promising and advanced asset, the Medsenic OATO autoimmune
disease platform. As a result, it can concentrate on the late-stage
phase III trial of oral arsenic trioxide targeting chronic
graft-versus-host disease. A 505 (b)2 procedure is on track with
the FDA,” said François Rieger, PhD, Chairman and Chief
Executive Officer of BioSenic.
“We want to make this new cGvHD treatment
available as quickly as possible for patients who currently have no
other serious therapeutic alternative. The decision to halt the
clinical development on difficult tibial fractures enables BioSenic
to add additional resources for the development of the OATO
platform and its current indications.”
About BioSenic
BioSenic is a leading biotech company
specializing in the development of clinical assets issued from:
(i), the allogeneic cell therapy platform ALLOB and (ii) the
Arsenic TriOxide (ATO) platform. Key target indications for the
platforms include Graft versus Host Disease (GvHD), Systemic lupus
erythematosus (SLE), Systemic Sclerosis (SSc) and high-risk tibial
fractures.Following the merger in October 2022, BioSenic combines
the strategic positionings and strengths of Medsenic and Bone
Therapeutics. The merger also enables Biosenic to add to its
innovative cell therapy platform and strong IP for tissue repair
protection with an entirely new arsenal of various
anti-inflammatory and anti-autoimmune formulations using the
immunomodulatory properties of 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 BioSenic technology
platforms
BioSenic’s technology is based on two main
platforms:
1) The allogeneic cell and gene
therapy platform, developed by BioSenic with differentiated bone
marrow sourced Mesenchymal Stromal Cells (MSCs) that can be stored
at the point of use in hospitals. Its current investigational
medicinal product, ALLOB, represents a unique, 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 a single local
injection. These cells are produced via a BioSenic's scalable
manufacturing process. Following the CTA approval by regulatory
authorities in Europe, BioSenic had initiated patient recruitment
for the Phase IIb clinical trial with ALLOB in patients with
difficult tibial fractures, using its optimized production process.
ALLOB was evaluated in a randomized, double-blind,
placebo-controlled Phase IIb study in patients with high-risk
tibial fractures, using its optimized production process, after a
successful first safety and efficacy study (Phase 1/2a) on
fractured long bones, with late delayed union. The patient
recruitment has been halted late February 2023 with 57 patients and
the new rules permitted for statistical analysis allowed BioSenic
to get the main results of this trial much earlier than anticipated
in the original protocol, by this mid-June
2023.2) The Arsenic TriOxide (ATO) platform
developed by Medsenic. The immunomodulatory properties of ATO have
demonstrated a double basic effect on cells of the immune system.
The first effect is the increase of the cell oxidative stress in
activated B, T or other cells of the innate/adaptative immune
system to the point they will enter a cell death program
(apoptosis) and be eliminated. The second effect is potent
immunomodulatory properties on several pro-inflammatory cytokines
involved in inflammatory or autoimmune cell pathways. One direct
application is its use in onco-immunology to treat GvHD
(Graft-versus-Host Disease) in its chronic, established stage. GvHD
is one of the most common and clinically significant complications
affecting long-term survival of allogeneic hematopoietic stem cell
transplantation (allo-SCT). GvHD is primarily mediated by the
transplanted immune system that can lead to severe multiorgan
damage. Medsenic had been successful in a Phase II trial with its
intravenous formulation, allowing arsenic trioxide to be granted an
orphan drug designation status by FDA and EMA and is heading
towards an international Phase III confirmatory study, with a new,
IP protected, oral (OATO) formulation. Moderate to Severe forms of
Systemic Lupus erythematosus (SLE) is another selected target,
using the same oral formulation. ATO has shown good safety and
significant clinical efficacy on several affected organs (skin,
mucosae and the gastro-intestinal tract) in a Phase IIa study.
Systemic Sclerosis is, in addition, part of the clinical pipeline
of BioSenic. Preclinical studies on pertinent animal models are
positive. This gives good grounds to launch a Phase II clinical
protocol for this serious disease that badly affects skin, lungs or
vascularization, and with no actual current effective
treatment.
In addition, BioSenic is developing a
next-generation, off-the-shelf, enhanced viscosupplement, JTA,
consisting of a unique combination of plasma proteins, hyaluronic
acid (a natural component of synovial fluid in the knee) and a
third active component. JTA or some derivatives intend to provide
added lubrication and protection to the cartilage of the arthritic
joint and to alleviate osteoarthritic pain (OA) and inflammation.
In March 2023, after the identification of new OA subtypes,
BioSenic delivered a new post-hoc analysis of its Phase III JTA-004
trial on knee OA with positive action on the most severely affected
patient population. This new post-hoc analysis drastically changes
the therapeutic profile of the combined components and allows for
better patient targeting in new clinical developments. The company,
which does not intend to allocate R&D resources to support the
clinical development of JTA-004 itself will focus its R&D
activities on the development of its autoimmune (ATO) platform.
For further information, please
contact:
BioSenic SAPr. François Rieger,
PhD, Chief Executive OfficerTel: +33 (0)671 73 31
59investorrelations@biosenic.com
For 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
22ggasparetto@actifin.fr
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