Lyra Therapeutics Announces Positive Topline Results of Pharmacokinetic Study of LYR-210 in Patients with Chronic Rhinosinusi...
June 30 2021 - 7:00AM
Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage
therapeutics company leveraging its proprietary XTreo™ platform to
enable precise, sustained, and local delivery of medications to the
ear, nose and throat (ENT) passages and other diseased tissues,
today announced positive topline results from the company’s
pharmacokinetic (PK) study of LYR-210. Data obtained from the study
are supportive of LYR-210’s safety profile and provide a PK bridge
to the established safety of mometasone furoate (MF) for a
505(b)(2) pathway for New Drug Approval (NDA) submission.
The clinical study was a 56-day open label,
multi-center, U.S. study of the PK and safety of LYR-210 in adult
subjects with chronic rhinosinusitis (CRS). The primary objective
of the study was to establish the PK profile of LYR-210. The study
enrolled 24 patients, half of whom received LYR-210 2500 µg and the
other half received LYR-210 7500 µg. The study indicated that both
doses were safe and well tolerated, with the mean maximum plasma
concentration (Cmax) observed with the 7500 ug dose well below Cmax
established for U.S. Food and Drug Administration-approved
formulations of MF. MF blood plasma levels observed during the PK
study support LYR-210’s ability to deliver consistent and steady
dosing over the entire treatment period. This was the first U.S.
study of LYR-210 and it was fully enrolled across four sites in 11
weeks.
“The data from our PK study suggests that
LYR-210 can elute mometasone furoate safely, consistently for 6
months, and locally to the inflamed mucosal tissue of CRS
patients,” said Maria Palasis, PhD, President and Chief Executive
Officer of Lyra Therapeutics. “These results will support a
505(b)(2) pathway for LYR-210’s NDA submission. We are delighted at
the rapid pace of enrollment of our first U.S. patients, and
believe this bodes well for interest at U.S. sites for our Phase 3
program, which we expect to initiate around the end of the
year.”
“LYR-210 is highly convenient to implant and
explant in a routine office visit and seamlessly conforms to the
patient’s nasal anatomy which enables continuous treatment for up
to six-months with one application,” said Randall Ow, MD, FACS,
FARS, FAAOA, FAPCR, of Sacramento Ear Nose & Throat, and an
investigator in the PK study. “LYR-210 has the potential to address
a broad patient population and could provide a meaningful treatment
option to CRS patients who fail medical management.”
Lyra will present the data from its PK study of
LYR-210 during a podium presentation at the upcoming American
Rhinologic Society Annual meeting in October 2021.
About LYR-210
LYR-210 is an investigational product candidate
that utilizes Lyra’s proprietary XTreoTM platform to enable six
months of local, intra-nasal, anti-inflammatory therapy from a
single treatment for chronic rhinosinusitis (CRS). LYR-210 is
designed as a non-invasive alternative to sinus surgery for the
millions of CRS patients who have failed medical management. It is
a bioresorbable polymeric matrix designed to be administered in a
brief, non-invasive, in-office procedure and is intended to deliver
up to six months of continuous mometasone furoate drug therapy to
the sinonasal passages. In the LANTERN Phase 2 study, LYR-210 (7500
µg) demonstrated rapid, clinically meaningful and durable symptom
improvement in CRS three cardinal symptoms (3CS) over six months.
There are approximately 14 million patients with CRS in the US,
approximately 4 million of whom fail current standard of care
medical management.
About Lyra Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage
therapeutics company leveraging its proprietary XTreo™ platform to
enable precise, sustained, local delivery of medications to
diseased tissues not accessible with conventional therapeutic
approaches. Lyra’s XTreo™ platform is comprised of a biocompatible
mesh scaffold, an engineered elastomeric matrix and a versatile
polymer-drug complex. The company’s current pipeline of
therapeutics target tissues deep in the ear, nose and throat
passages and are designed to deliver continuous drug therapy for
months following a single non-invasive, in-office administration.
Lyra’s lead product candidate, LYR-210, is in late-stage clinical
development for the treatment of chronic rhinosinusitis and is
designed to deliver up to six months of continuous
anti-inflammatory drug therapy to the sinonasal passages. For more
information, please visit www.lyratherapeutics.com and follow us on
LinkedIn and Twitter.
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 clinical advancement of LYR-210 for the
treatment of CRS. 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 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 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 relies 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; 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
Quarterly Report on Form 10-Q filed with
the SEC on May 11, 2021 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.
Investor Contact:Argot
Partners212-600-1902argot@lyratherapeutics.com
Media Contact:Kathryn
Morris914-204-6412kathryn@theyatesnetwork.com
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