Lyra Therapeutics Announces Restart of Pivotal Phase 3 ENLIGHTEN II Clinical Trial of LYR-210 in Chronic Rhinosinusitis
April 25 2023 - 7:59AM
Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a
clinical-stage biotechnology company developing innovative
therapies for the localized treatment of chronic rhinosinusitis
(CRS), today announced that it has resumed screening and enrollment
in ENLIGHTEN II, its second pivotal Phase 3 clinical trial of
LYR-210 in patients with CRS. LYR-210 is a bioresorbable nasal
implant designed as an alternative to sinus surgery for the
millions of CRS patients who remain symptomatic despite treatment.
The ENLIGHTEN program consists of two pivotal
Phase 3 clinical trials, ENLIGHTEN I and ENLIGHTEN II, to evaluate
the efficacy and safety of LYR-210 for the treatment of CRS.
Enrollment in the ENLIGHTEN I clinical trial remains on track, with
pivotal data anticipated in 1H 2024. Lyra announced in November
2022 that it temporarily paused enrollment in ENLIGHTEN II due to a
transition to in-house manufacturing to ensure consistent clinical
supply of LYR-210. The Company expects to complete enrollment in
the ENLIGHTEN II trial in the second half of 2024. Lyra is
manufacturing LYR-210 in house for both ENLIGHTEN trials.
“Our in-house manufacturing team was able to
expedite the increased production of LYR-210 to allow us to resume
enrollment in ENLIGHTEN II ahead of our original expectation of
third quarter of 2023,” said Maria Palasis, Ph.D., President and
CEO of Lyra. “We believe that Lyra’s internal manufacturing
capabilities and quality systems will continue to strengthen our
ability to expedite our promising candidates toward approval and
commercialization, while reducing regulatory risk and risks
associated with technology transfer to third parties.”
Each ENLIGHTEN trial is enrolling 180 CRS
patients who have failed medical management and have not had prior
ethmoid sinus surgery, randomized 2:1 to either LYR-210 (7500µg
mometasone furoate (MF)) or control. Together, the two pivotal
trials are expected to support an anticipated New Drug Application
to the U.S. Food and Drug Administration for LYR-210.
About LYR-210
LYR-210 is an investigational product candidate
for use in chronic rhinosinusitis (CRS) patients who have failed
current treatments and require further intervention. LYR-210 is a
bioresorbable nasal implant administered in a brief in-office
procedure. LYR-210 is intended to deliver up to six months of
continuous, proven anti-inflammatory therapy, mometasone furoate,
to the sinonasal passages to treat CRS. In the LANTERN Phase 2
randomized, controlled trial of LYR-210 for the treatment of CRS,
LYR-210 achieved rapid and durable improvement in the SinoNasal
Outcome Test (SNOT-22) score over 24 weeks. No treatment-related
Serious Adverse Events (SAEs) were observed. LYR-210 is being
evaluated in the ENLIGHTEN Phase 3 pivotal clinical program.
About Lyra
Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage
biotechnology company developing therapies for the localized
treatment of patients with chronic rhinosinusitis (CRS). Lyra has
two investigational product candidates, LYR-210 and LYR-220, in
late-stage development for CRS, a highly prevalent inflammatory
disease of the paranasal sinuses which leads to debilitating
symptoms and significant morbidities. LYR-210 and LYR-220 are
bioresorbable nasal implants designed to be administered in a
brief, in-office procedure and are intended to deliver six months
of continuous mometasone furoate drug therapy (7500µg MF) to the
sinonasal passages. LYR-210 is designed for surgically naïve
patients and is being evaluated in the ENLIGHTEN Phase 3 clinical
program, while LYR-220, an enlarged implant, is being evaluated in
the BEACON Phase 2 clinical trial in patients who have recurrent
symptoms despite having had prior ethmoid sinus surgery. These two
product candidates are designed to treat the estimated four million
CRS patients in the United States who fail medical management each
year. For more information, please visit www.lyratx.com and follow
us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements contained in this press release
that do not relate to matters of historical fact should be
considered forward-looking statements, including statements
regarding the Company’s cash runway through mid-2024, the Company’s
pipeline of product candidates, the enrollment and success of the
ENLIGHTEN Phase 3 program, the timing for reporting top line data
from the Company’s clinical trials, the Company’s ability to
manufacture its product candidates, and the success of the Phase 2
BEACON trial. These statements are neither promises nor guarantees,
but involve known and unknown risks, uncertainties and other
important factors that may cause the company's actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: the fact that the company has incurred significant
losses since inception and expects to incur additional losses for
the foreseeable future; the company's need for additional funding,
which may not be available; the company's limited operating
history; the fact that the company has no approved products; the
fact that the company's product candidates are in various stages of
development; the fact that the Company has never scaled up a
manufacturing facility for commercial use; or the fact that the
company may not be successful in its efforts to identify and
successfully commercialize its product candidates; the fact that
clinical trials required for the company's product candidates are
expensive and time-consuming, and their outcome is uncertain; the
fact that the FDA may not conclude that certain of the company's
product candidates satisfy the requirements for the Section
505(b)(2) regulatory approval pathway; the company's inability to
obtain required regulatory approvals; effects of recently enacted
and future legislation; the possibility of system failures or
security breaches; effects of significant competition; the fact
that the successful commercialization of the company's product
candidates will depend in part on the extent to which governmental
authorities and health insurers establish coverage, adequate
reimbursement levels and pricing policies; failure to achieve
market acceptance; product liability lawsuits; the fact that the
company must scale its in-house manufacturing capabilities or rely
on third parties for the manufacture of materials for its research
programs, pre-clinical studies and clinical trials; the company's
reliance on third parties to conduct its preclinical studies and
clinical trials; the company's inability to succeed in establishing
and maintaining collaborative relationships; the company's reliance
on certain suppliers critical to its production; failure to obtain
and maintain or adequately protect the company's intellectual
property rights; failure to retain key personnel or to recruit
qualified personnel; difficulties in managing the company's growth;
effects of natural disasters, terrorism and wars (including the
developing conflict between Ukraine and Russia); the
fact that the global pandemic caused by COVID-19 could adversely
impact the company's business and operations, including the
company's clinical trials; the fact that the price of the company's
common stock may be volatile and fluctuate substantially;
significant costs and required management time as a result of
operating as a public company and any securities class action
litigation. These and other important factors discussed under the
caption "Risk Factors" in the company's Annual Report on Form 10-K
filed with the SEC on March 29, 2023 and its
other filings with the SEC could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management's estimates as of the date of this
press release. While the company may elect to update such
forward-looking statements at some point in the future, it
disclaims any obligation to do so, even if subsequent events cause
its views to change.
Contact Information:Ellen
Cavaleri, Investor Relations 615.618.6228 ecavaleri@lyratx.com
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