Full Press Release Details
Lyra Therapeutics Announces Positive Topline Results for LANTERN Phase 2 Randomized Controlled Study of LYR-210 for the Treatment of Chronic Rhinosinusitis With and Without Nasal Polyps
Watertown, Mass. December 7, 2020 Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company focused on
the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases, today announced positive topline results from the LANTERN Phase 2 study of LYR-210 for chronic rhinosinusitis (CRS).
The LANTERN study was a randomized, patient blinded, controlled clinical
trial designed to evaluate the efficacy and safety of LYR-210 in adult patients with CRS, including patients with and without nasal polyps, who had not previously undergone sinus surgery. CRS is diagnosed when
2 or more of the 4 cardinal symptoms (4CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure, and reduction or loss of sense of smell) persist for 12 weeks or longer and when inflammation is confirmed via endoscopy or a CT scan.
The multi-center study enrolled 67 patients at sites in Europe, New Zealand and Australia. Patients in the study were randomized 1:1:1 into three groups: 7500
mcg (21 patients) or 2500 mcg (23 patients) of continuous mometasone furoate therapy, or control (23 patients).
LYR-210 is an investigational product candidate designed to be administered
in-office, into the sinonasal passages, and to deliver a sustained release therapeutic up to six months at difficult-to-access
nasal inflammation sites without the need for patient compliance, as a non-invasive alternative to surgery for patients who have failed medical management.
We are delighted to share this positive data from our LANTERN trial, which represents a major milestone for Lyra, and which shows the potential for LYR-210 to improve a composite of cardinal symptoms of CRS for up to 24 weeks. We believe this trial represents the first time a nasal implant has achieved six months of benefit for CRS patients via a single
administration in clinical testing. These data are yet more remarkable given it was achieved during the COVID-19 pandemic, which caused us to curtail enrollment sooner than originally planned, said Maria
Palasis, PhD, CEO of Lyra Therapeutics. Furthermore, the 4CS efficacy data is backed up by impressive SNOT-22 scores, supporting the potential pronounced treatment effect of LYR-210.
Maria Palasis continued: Importantly, this is the first time that a drug-releasing nasal implant
has been observed to improve symptoms in both non-polyp and polyp patients, and also marks the first time such an implant has exhibited a dose response, which we believe validates our underlying XTreo platform. We believe these results confirm our pathway to regulatory submission, and we will move forward quickly to initiate a Phase 3 study in CRS, subject to a planned end-of-Phase 2 meeting with the FDA. In addition, we are continuing our development efforts for LYR-220, for CRS patients who have
already undergone sinus surgery. I would like to thank everyone involved in the LANTERN study and look forward to updating you on our next steps as we seek to change the treatment paradigm for long-underserved CRS patients.
Other takeaways from the LANTERN study include:
The LANTERN study results are very exciting to those of us in the ENT community who are eager to embrace new treatment options for CRS, including
alternatives to surgery. Based on my experience in Lyra s Phase 1 and Phase 2 studies for LYR-210, I believe a drug-releasing nasal implant that may offer up to six months treatment would represent an
important innovation for CRS patients, said A/Prof Joanne Rimmer, an ENT surgeon and rhinologist at Monash Health,
Associate Professor at Monash University in Melbourne, Australia, and an investigator in the LANTERN study. The in-office procedure of placing LYR-210 into a patient s nose is straightforward, suggesting that LYR-210 may have the potential to improve quality of life for patients who have failed medical
management while offering an alternative to invasive surgical procedures.
CRS is a chronic, lifelong condition, and there continues to be a
need for innovation for the millions of people suffering from this inflammatory disease. As such, the LANTERN results are very encouraging, particularly as there are currently no FDA-approved therapeutic
treatments for CRS patients without nasal polyps, despite that patient population representing approximately 70-90% of all CRS patients, said Robert Kern, MD, Chair of Otolaryngology, Head and Neck
Surgery, at Northwestern Medical Center and Professor of Otolaryngology at the Feinberg School of Medicine at Northwestern. I believe this innovative long-acting investigational treatment has the potential to make a meaningfully positive
impact on patients quality of life and offer an appealing alternative to invasive medical procedures.
The company plans to host a conference call to discuss the results today at 8:30 am ET. Individuals interested in listening to the conference call may do so by
dialing (833) 519 1249 for domestic callers, or (914)800 3822 for international callers and reference conference ID: 5134448; or from the webcast link in the investor relations section of the company s website at: www.lyratherapeutics.com.
The live webcast can be accessed here and will be available in the investor relations section on the company s website for 30 days following the
completion of the call. In light of reduced call center resources during this time of required social-distancing, Lyra requests that listeners who do not plan on participating in the question and answer session listen to the live webcast rather than
dialing in by phone.
LANTERN Phase 2 Trial Design
The Phase 2 LANTERN study was conducted in 67 adult patients with CRS, including patients with and without nasal polyps who had not undergone sinus surgery.
Patients in the study were randomized 1:1:1 into three groups to receive in-office bilateral nasal administration of either one of two long-acting dose levels of
LYR-210, 7500 mcg (21 patients) or 2500 mcg (23 patients) of continuous anti-inflammatory drug therapy, mometasone furoate, or control (23 patients). The multi-center study was conducted at sites in
Europe, New Zealand and Australia.
The trial was originally designed to enroll 99 evaluable patients with the potential to increase to up to 150 patients
and was initiated in May 2019. However, in light of developments relating to the COVID-19 global pandemic we discontinued enrollment at 67 patients in our Phase 2 LANTERN clinical trial. As a result of the
decrease in the number of patients enrolled from planned (99) to actually enrolled (67) patients in our Phase 2 LANTERN clinical trial, a greater magnitude of change in composite score of the
seven-day average of four cardinal symptoms from baseline at week 4 and/or a smaller standard deviation associated with the change from baseline at week 4 was required in order for the trial to achieve
statistical significance for the primary endpoint.
About Lyra Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery
solutions for the localized treatment of patients with ear, nose and throat (ENT) diseases. The company s lead product candidate,
LYR- 210, is designed to deliver up to six months of continuous anti-inflammatory drug therapy to the sinonasal passages for the treatment of chronic rhinosinusitis (CRS) in patients who have not
undergone surgery for the disease. Lyra is also developing LYR-220 for CRS patients who have undergone a prior surgery and have persistent disease. Beyond CRS, the company believes its XTreo platform, comprised of drug administered through a bioresorbable polymeric matrix, has the potential to address other disease areas by precisely, consistently and locally delivering medicines
for sustained periods with a single administration.
LinkedIn and Twitter @LyraTx.
Forward-Looking Statement
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 lead product candidate LYR-210, the
presentation of top-line results relating to the Company s Phase 2 LANTERN clinical trial for LYR-210 and the Company s plans to initiate a pivotal Phase 3
study for LYR-210 in CRS for both non-polyp and polyp patients. 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 November 10, 2020
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.