Lyra Therapeutics Announces First Patient Treated in Phase 2 BEACON Clinical Trial of LYR-220 in Post-Surgical Chronic Rhinosinusitis Patients
"We have limited and often ineffective treatment options to alleviate persistent, burdensome symptoms in CRS patients that have been previously operated on," said
The Phase 2 BEACON trial is a controlled parallel-group study to evaluate safety, tolerability, pharmacokinetics, and efficacy comparing two designs of the LYR-220 (7500µg MF) matrix to control, over a 24-week period, in approximately 70 symptomatic adult CRS subjects who have had a prior bilateral sinus surgery. Part 1 is a non-randomized, open-label study assessing the feasibility of placement optimizing the procedure, while Part 2 will be a patient-blinded, 1:1:1 randomized assessment of two designs versus sham control. The Company anticipates completing enrollment for the full Phase 2 BEACON trial around year end.
"This represents a significant milestone for Lyra as we advance our second CRS product candidate into late-stage development, positioning us to potentially be the first to offer solutions for the full spectrum of CRS patients treated by ENT physicians," said Maria Palasis, PhD, President and Chief Executive Officer of
LYR-220 is an investigational product candidate that utilizes Lyra's proprietary XTreo™ platform to enable six months of local, intra-nasal, anti-inflammatory therapy from a single treatment for chronic rhinosinusitis (CRS) in patients with post-surgical anatomy, a population which represents roughly forty percent of the four million CRS patients who fail medical management annually. LYR-220 is designed as a non-invasive alternative to repeat sinus surgery for CRS patients who have an enlarged nasal cavity due to sinus surgery but continue to require treatment to manage CRS symptoms. LYR-220 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.
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 enrollment and success of the Phase 2 BEACON study, the timing for topline results from Part 1 of the Phase 2 BEACON trial and the timing for completing enrollment for the full 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 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; 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 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, terrorism and wars (including the developing conflict between
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