Bone Biologics Corporation (NASDAQ: BBLG), a developer of
orthobiologic products for spine fusion markets, provides an update
on its clinical development initiatives with its NB1 bone graft
device.
NB1 consists of the recombinant human protein NELL-1 combined
with demineralized bone matrix (DBM). The 30-patient pilot study is
expected to be conducted in Australia. Earlier this year, the Human
Research Ethics Committee approved Monash Health as the first
site.
“We are encouraged by the ongoing progress in preparing to
advance NB1 into human testing and look forward to the start of our
pilot study before the end of the year,” said Jeffrey Frelick,
president and chief executive officer of Bone Biologics.
The company has completed the following preparatory
activities:
Assay Qualification
and Validation
All analytical assays required for the drug
substance and the drug product have been successfully validated.
Similar recombinant human NELL-1 (rhNELL-1) drug substance
attributes were demonstrated between different rhNELL-1 lots and
the cGMP drug substance lot.
The in vitro cell-based attachment potency
assay has been successfully qualified. Similar relative potency was
demonstrated between different rhNELL-1 lots and the cGMP drug
substance lot has passed the potency specification. In vivo potency
testing demonstrated osteopromotion activity for the cGMP rhNELL-1
drug substance.
The engineering and the cGMP drug substance
lots have passed all required specifications.
Medical Device
Biocompatibility Testing
The ISO 10993 GLP biocompatibility testing
has been completed. NB1 showed no evidence of causing cell lysis or
toxicity, no sensitization and was not mutagenic or pyrogenic. The
clinical observations, body weights, necropsy observations, organ
weights, organ/body weight ratios and organ/brain weight ratios
were not adversely affected by implantation of NB1 or control
articles. There were no changes in hematology or clinical chemistry
values considered related to NB1 implantation. Microscopic
evaluation of collected organs revealed no evidence of a systemic
test article related response.
Master Cell Bank
Safety
The master cell bank biosafety testing was
successfully completed.
Stability
rhNELL-1 drug product stability was
demonstrated for purity, potency visual appearance, color, clarity,
pH and protein concentration up to six months.
The planned pilot clinical trial is a multicenter, parallel
group, randomized trial designed to evaluate the safety and
preliminary effectiveness of NB1 bone graft in 30 subjects with
degenerative disc disease undergoing a TLIF procedure.
Mr. Frelick added, “We believe NB1 is poised to address the
problems with existing bone growth products by providing rapid,
controlled and guided bone growth only in the presence of existing
bone. Our longer-term goal is to capture a meaningful portion of
the $3 billion annual global market for spine fusion products.
Lumbar degenerative disc disease is a common cause of lower back
pain, which may lead to disability. We are excited to be embarking
on a potential opportunity to improve quality of life for millions
of patients.”
About NELL-1
NELL-1 is a recombinant human protein licensed through a
technology transfer agreement with the UCLA Technology Development
Group for worldwide applications. NELL-1 combined with DBM forms
the product candidate, NB1.
The inclusion of rhNELL-1 in the NB1 bone graft device provides
an ancillary osteopromotive effect that is expected to increase
both the quantity and maturity of bone and to increase the rate of
spinal fusion. The proposed mechanism of action for rhNELL-1 to
improve bone formation involves classic receptor binding and
intracellular signaling transduction to the nucleus to promote
osteogenic gene expression and bone formation.
NELL-1 has unique properties that suggest it will be ideal in
treating spinal fusion, trauma, osteoporosis and other bone-related
indications, and may be especially useful among “hard healers.”
This potential lies in its ability to provide rapid, specific and
guided control over bone regeneration. The company is optimistic
that NB1 may provide an important alternative to a vexing clinical
problem by improving the safety profile of an osteopromotive
orthobiologic.
There is a large and established opportunity for NB1 with an
estimated global market of $3 billion annually just for bone graft
substitutes in spine fusion for products such as growth factors,
DBM, synthetic materials, stem cells and allografts. This is the
market Bone Biologics intends to address. Longer term, additional
market opportunities await NB1 including the $11 billion annual
market for treating osteoporosis and the $8 billion annual market
for treating trauma patients.
About Bone Biologics
Bone Biologics is undertaking groundbreaking work with select
strategic partners that builds on the preclinical research of the
NELL-1 protein. Bone Biologics is currently focusing its
development efforts for its bone graft substitute product on bone
regeneration in spinal fusion procedures, while additionally having
rights to trauma and osteoporosis applications. For more
information, please visit www.bonebiologics.com.
Forward-looking Statements
Certain statements contained in this press release, including,
without limitation, statements containing the words ‘'believes,''
"expected” “will,” “before,” “planned,” “goal,” “may,” “intends,”
and words of similar import, constitute "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements involve both
known and unknown risks and uncertainties including the ability for
the Company to advance NB1 into human testing; the timing of the
Company’s pilot clinical study; related risks involved in drug
development, clinical trials, regulation, uncertainties around
regulatory reviews and approvals; the preclinical and clinical
results for NB1, which may not support further development; the
Company’s ability to successfully demonstrate the safety and
efficacy of its product candidates and gain approval of its product
candidates on a timely basis, if at all; and the Company’s ability
to capture any portion of the $3 billion annual global market for
spine fusion products. The Company's actual results may differ
materially from those anticipated in its forward-looking statements
as a result of a number of factors, including those including the
Company's ability to develop our lead product NELL-1 and other
proposed products, its ability to obtain patent protection for its
technology, its ability to obtain the necessary financing to
develop products and conduct the necessary clinical testing, its
ability to obtain Federal Food and Drug Administration approval to
market any product it may develop in the United States and to
obtain any other regulatory approval necessary to market any
product in other countries, its ability to market any product it
may develop, its ability to create, sustain, manage or forecast its
growth; its ability to attract and retain key personnel; changes in
the Company's business strategy or development plans; competition;
business disruptions; adverse publicity and international, national
and local general economic and market conditions and risks
generally associated with an undercapitalized developing company,
as well as the risks contained under "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and
Results of Operations" in the Company's Form S-1, Form 10-K for the
year ended December 31, 2022 and the Company's other filings with
the Securities and Exchange Commission. Except as required by
applicable law, we undertake no obligation to revise or update any
forward-looking statements to reflect any event or circumstance
that may arise after the date hereof.
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version on businesswire.com: https://www.businesswire.com/news/home/20230926590925/en/
LHA Investor Relations Kim Sutton Golodetz 212-838-3777
kgolodetz@lhai.com
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