Organogenesis Achieves Primary Endpoint in Phase 3 Clinical Trial of ReNu® for Knee Osteoarthritis
May 02 2024 - 6:00AM
Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative
medicine company focused on the development, manufacture, and
commercialization of product solutions for the Advanced Wound Care
and Surgical and Sports Medicine markets, today announced that its
Phase 3 randomized control trial evaluating the safety and efficacy
of ReNu, a cryopreserved amniotic suspension allograft (ASA), for
the management of symptoms associated with knee osteoarthritis (OA)
achieved its primary endpoint upon the analysis of positive top
line data.
The study demonstrated a statistically significant reduction in
knee OA pain at six months as assessed by the Western Ontario and
McMaster Universities Arthritis Index pain scale compared with
subjects treated with saline control. ReNu showed a favorable
safety profile consistent with prior studies.
“These top line results are a milestone achievement for
Organogenesis,” said Gary S. Gillheeney, Sr., President and Chief
Executive Officer of Organogenesis. “We look forward to sharing
this compelling new evidence in our ongoing discussions with the
FDA as we believe ReNu can provide clinically meaningful benefits
where few non-surgical options exist. If approved, introducing Renu
as an innovative pain management solution for the millions of
patients suffering from knee OA represents a significant new
addressable market opportunity for Organogenesis.”
Knee OA is a degenerative joint disease that is estimated to
affect nearly 31.1 million Americans and projected to grow to 34.4
million Americans by 2027. It is ranked among the most common
causes of disability and poor quality of life, generally
characterized by pain and functionality deficits. Up to 15 percent
of knee OA patients are classified as severe (Kellgren-Lawrence
[KL] grade 4). End stage management of the disease in these
patients is typically a total knee replacement when all other
treatment options are exhausted.
“To date, non-surgical treatment options for severe OA patients
(KL 4) are limited—which represented approximately 30% of the
enrolled patient population for this study,” said Adam B. Yanke,
MD, PhD, Associate Professor of Orthopedics at Rush University
Medical Center, a sports medicine and orthopedic surgeon and
Co-Principal Investigator. “These topline results provide
statistically significant evidence that the use of ReNu is a safe,
effective treatment option for knee OA patients, if approved.”
A total of 515 patients with moderate to severe symptomatic knee
OA (KL severity grade 2 to grade 4) were randomized to receive a
single intra-articular injection of either ReNu or saline control
balanced across groups. Patients were randomized to receive ReNu
(ASA) 2 mL diluted with 2 mL of saline or 4 mL saline control.
Statistically significant reductions in assessed knee pain
(p=0.0177) were detected in the ReNu arm compared to the saline
control arm six months after injection, and similar rates of
adverse events were observed through 12 months of follow up. In
addition to improving knee OA pain symptoms, ReNu maintained
patient function compared to saline control (p < 0.0001).
“ReNu is supported by a robust and growing volume of scientific
evidence,” said Patrick Bilbo, Chief Operating Officer of
Organogenesis. “Based on the positive results of this pivotal trial
along with our accumulated safety and efficacy data, we now plan to
request a meeting with the FDA to discuss the clinical data
requirements for a Biologics License Application filing. We look
forward to having an update to share later this year and to
initiating further studies to expand the potential clinical
indications of ReNu.”
Complete analysis of the Phase 3 prospective, double-blind,
multicenter, saline-controlled, parallel group clinical trial is
expected in May. A second multi-center clinical trial for ReNu is
actively enrolling with full enrollment expected this year, ahead
of earlier expectations.
About ReNu® ReNu is a cryopreserved, amniotic
suspension allograft (ASA) developed for the management of
symptomatic knee osteoarthritis. ReNu consists of amniotic fluid
cells and micronized amniotic membrane and contains cellular,
growth factor, and extracellular matrix components. ReNu received
FDA Regenerative Medicine Advanced Therapy (RMAT) designation for
Knee OA in 2021.
About Organogenesis Holdings Inc.Organogenesis
Holdings Inc. is a leading regenerative medicine company focused on
the development, manufacture, and commercialization of solutions
for the advanced wound care and surgical and sports medicine
markets. Organogenesis offers a comprehensive portfolio of
innovative regenerative products to address patient needs across
the continuum of care.
Forward-Looking StatementsThis release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
regarding our ReNu product. These forward-looking statements relate
to expectations or forecasts of future events. Forward-looking
statements may be identified by the use of words such as
“forecast,” “intend,” “if approved,” “seek,” “target,”
“anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,”
and “project” and other similar expressions that predict or
indicate future events or trends or that are not statements of
historical matters. These statements concern, and these risks and
uncertainties include, among others: the risks and uncertainties
inherent in clinical development; that interim results are not
necessarily indicative of final results; that other clinical trials
of ReNu may produce different results; the likelihood and timing of
possible regulatory approval and commercial launch of ReNu;
determinations by regulatory and administrative governmental
authorities which may delay or restrict our ability to develop or
commercialize ReNu; ongoing regulatory obligations and oversight
impacting ReNu; unforeseen safety issues resulting from the
administration of ReNu in patients; competing products and product
candidates that may be superior to our products and product
candidates; uncertainty of market acceptance and commercial success
of ReNu and the impact of studies (whether conducted by us or
others and whether mandated or voluntary) on the commercial success
of ReNu; our ability to manufacture and manage supply components
for ReNu; the availability and extent of reimbursement of ReNu from
third-party payers, including private payer healthcare and
insurance programs and government programs such as Medicare and
Medicaid; coverage and reimbursement determinations by such payers,
including local coverage determinations by Medicare Part A/B
Medicare Administrative Contractors; new policies and procedures
adopted by such payers; unanticipated expenses; the costs of
developing, producing, and selling ReNu; our ability to meet our
sales or other financial projections or guidance and changes to the
assumptions underlying those projections or guidance; and other
risks and uncertainties described in our filings with the
Securities and Exchange Commission, including Item 1A (Risk
Factors) of our Form 10-K for the year ended December 31, 2023 and
our subsequently filed periodic reports. You are cautioned not to
place undue reliance upon any forward-looking statements, which
speak only as of the date made. Although we may voluntarily do so
from time to time, we undertake no commitment to update or revise
the forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
applicable securities laws.
Investor Inquiries:
ICR Westwicke
Mike Piccinino, CFA
OrganoIR@westwicke.com
Press and Media Inquiries:
Organogenesis
communications@organo.com
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