Bone Therapeutics announces topline results from Phase III knee
osteoarthritis study with its enhanced viscosupplement JTA-004
REGULATED INFORMATION
No statistically significant difference in knee
pain reduction between JTA-004, placebo and active comparator,
3 months after treatment; favorable JTA-004 safety profile
similar to placebo and comparator
Prime focus on the continued development and
expansion of its mesenchymal stromal cell based allogeneic cell and
gene therapy platform
Management to host conference call today at 4pm
CEST / 10am EST - details provided below
Gosselies, Belgium,
30 August 2021, 7am CEST – BONE
THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the
cell therapy company addressing unmet medical needs in orthopedics
and other diseases, today announces that the Phase III knee
osteoarthritis study with its enhanced viscosupplement JTA-004 did
not meet the primary and consequently the key secondary
endpoints.
The primary objective of the JTA-004 Phase III
study was to demonstrate the efficacy of JTA-004 in reducing
osteoarthritic knee pain compared to placebo as measured by the
WOMAC® pain subscale three months after treatment. A key secondary
objective was the comparison between JTA-004 and comparator Hylan
G-F 20 in knee pain relief at month 3. Despite JTA-004’s favorable
safety profile, the study did not achieve its main objectives as no
statistically significant difference in pain reduction could be
observed between any of the treatment, placebo and comparator
groups, with all treatment arms showing similar efficacy.
A statistically significant difference in favor
of JTA-004 and the active comparator versus placebo was seen in a
post-hoc analysis in a subset of patients with higher pain scores
at entry.
The Company, in collaboration with existing and
potential partners, will consider the options for the future of
JTA-004 development.
“The execution of the study was flawless and a
good safety profile was observed in line with previous results.
These JTA-004 efficacy results are disappointing. Knee
osteoarthritis studies are recognized across the industry to be
challenging to evaluate. They are also frequently complicated by a
high placebo effect. We will continue to analyze the data and will
consider potential next steps,” said Miguel Forte, Chief
Executive Officer of Bone Therapeutics. “We are now fully
committed to the clinical development of our advanced MSC
allogeneic cell and gene therapy platform. Bone Therapeutics is
concentrating on the development of this platform for the large
market of orthopedic indications, with ALLOB. The progress with
this platform has enabled us to expand it to other indications,
including immunomodulation.”
Bone Therapeutics is focused on the development
of its core assets, the allogeneic cell therapy platform, including
ALLOB. ALLOB is currently being evaluated in a randomized,
double-blind, placebo-controlled Phase IIb study in
178 patients with fresh tibial fractures at risk of delayed or
non-union. 5% to 10% of complicated long bone fractures evolve to
delayed union and non-union. This study will assess the potential
for a single percutaneous injection of ALLOB to accelerate fracture
healing and prevent late-stage complications in these patients.
Recruitment is expected to be completed in the first half of 2022
and topline results by the end of 2022. Should the pandemic
continue, Bone Therapeutics may have to re-evaluate these timelines
and, in that eventuality, will communicate again to the market.
Bone Therapeutics is intensifying its efforts to
expand its preclinical and clinical pipeline with additional
indications by enhancing and “professionalizing” the therapeutic
capacity of its cell and gene therapy platform. This includes the
development of a next generation of genetically engineered
mesenchymal stromal cells (MSC) and the use of highly scalable and
versatile cell sources such as induced pluripotent stem cells
(iPSC).
Conference call
The management of Bone Therapeutics will host a
conference call today at 4:00 pm CEST / 10:00 am EST. To
participate in the conference call, please select your dial-in
number from the list below quoting the conference ID 825 1002
3115#:
Belgium: +32 2 290 9360France: +33 1
7095 0103United Kingdom: +44 208 080 6592United States:
+1 646 876 9923
About JTA-004 and Phase III knee
osteoarthritis study
JTA-004 is Bone Therapeutics’ next generation of
intra-articular injectable for the treatment of osteoarthritic pain
in the knee. It consists of a unique mix of hyaluronic acid - a
natural component of knee synovial fluid, plasma proteins, and a
fast-acting analgesic. JTA-004 intends to provide added lubrication
and protection to the cartilage of the arthritic joint and to
alleviate osteoarthritic pain.
The JTA-004 Phase III study is a controlled,
randomized, double-blind trial. It evaluates the potential of a
single, intra-articular injection of JTA-004 to reduce
osteoarthritic pain in the knee, compared to placebo or Hylan G-F
20, the leading osteoarthritis treatment on the market. The study
is being conducted in 22 centers across six European countries as
well as Hong Kong. More than 700 patients with mild to moderate
symptomatic knee osteoarthritis were treated in this study.
About Knee Osteoarthritis
Osteoarthritis (OA), also known as degenerative
joint disease, is the most common chronic joint condition in which
the protective cartilage in the joints progressively break down
resulting in joint pain, swelling, stiffness and limited range of
motion. The knee is one of the joints that are mostly affected by
osteoarthritis, with an estimated 250 million cases worldwide.
The prevalence of knee osteoarthritis (KOA) is
expected to increase in the coming years due to increasingly aging
and obese population. Currently, there is no cure for KOA and
treatments focus on relieving and controlling pain and symptoms,
preventing disease progression, minimizing disability, and
improving quality of life. Most drugs prescribed to KOA patients
are topical or oral analgesics and anti-inflammatory drugs.
Ultimately, severe KOA leads to highly invasive surgical
interventions such as total knee replacement.
About Bone Therapeutics
Bone Therapeutics is a leading biotech company
focused on the development of innovative products to address high
unmet needs in orthopedics and other diseases. The Company has a
diversified portfolio of cell therapies at different stages ranging
from pre-clinical programs in immunomodulation to mid stage
clinical development for orthopedic conditions, targeting markets
with large unmet medical needs and limited innovation.
Bone Therapeutics’ core technology is based on
its cutting-edge allogeneic cell and gene therapy platform with
differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs)
which can be stored at the point of use in the hospital. Currently
in pre-clinical development, BT-20, the most recent product
candidate from this technology, targets inflammatory conditions,
while the leading investigational medicinal product, ALLOB,
represents a unique, proprietary approach to bone regeneration,
which turns undifferentiated stromal cells from healthy donors into
bone-forming cells. These cells are produced via the Bone
Therapeutics’ scalable manufacturing process. Following the CTA
approval by regulatory authorities in Europe, the Company has
initiated patient recruitment for the Phase IIb clinical trial with
ALLOB in patients with difficult tibial fractures, using its
optimized production process. ALLOB continues to be evaluated for
other orthopedic indications including spinal fusion, osteotomy,
maxillofacial and dental.
Bone Therapeutics’ cell therapy products are
manufactured to the highest GMP (Good Manufacturing Practices)
standards and are protected by a broad IP (Intellectual Property)
portfolio covering ten patent families as well as knowhow. The
Company is based in the BioPark in Gosselies, Belgium. Further
information is available at www.bonetherapeutics.com.
For further information, please
contact:
Bone Therapeutics SAMiguel
Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief
Financial OfficerTel: +32 (0)71 12 10
00investorrelations@bonetherapeutics.com
For Belgian Media and Investor
Enquiries:BepublicCatherine HaquenneTel: +32
(0)497 75 63 56catherine@bepublic.be
International Media Enquiries:Image Box
CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20
8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency
For French Media and Investor
Enquiries:NewCap Investor Relations &
Financial CommunicationsPierre Laurent, Louis-Victor
Delouvrier and Arthur RouilléTel: +33 (0)1 44 71 94
94bone@newcap.eu
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