Google “chronic rhinosinusitis” and you’ll find it’s the clinical name for the condition where sinuses are swollen and inflamed for three months or longer, despite treatment. Ask someone who suffers from it, and they’ll likely tell you it’s miserable. Swollen, painful and tender eyes, nose, and forehead. Congestion. Nasal discharge. Difficulty breathing and sleeping. The list goes on.
The number of people affected might surprise you. Sinusitis, which includes both chronic and acute forms, impacts about 30 million people in the United States, making it the fifth most common condition in people under the age of 65 – more than diabetes or heart disease. About 14 million have the chronic form, chronic rhinosinusitis (known as “CRS”), and 8 million are treated for it each year. Of those, 4 million fail to get better, despite medical intervention.
The journey to find relief can be long and frustrating for patients. The goals of therapy for CRS are to reduce mucosal swelling resulting from underlying inflammation, promote sinus drainage, and eradicate infections that may be present. Treatment typically begins with topical intranasal steroids, oral steroids, and antibiotics – each of which has significant limitations.
If those options don’t work, which we estimate is the case in perhaps 50% of CRS patients, the next step may be sinus surgery. During surgery, inflamed and obstructed sinus pathways are enlarged by removing inflamed tissue and bone to facilitate drainage and provide greater access for delivery of medications, primarily steroids. Surgery, while effective for some, requires general anesthesia and involves significant post-operative care and follow-up. In many cases it doesn’t correct the underlying inflammation or eliminate the need for medical management, and another round of surgery may be needed.
It’s time for some good news.
We recently announced the start of our Phase 2 BEACON clinical trial of LYR-220 for use in CRS patients who still struggle with the condition despite having had sinus surgery. LYR-220 is a bioresorbable matrix placed in the nasal cavity during a brief, non-invasive, in-office procedure. Its flexible structure conforms to the patient’s nasal anatomy and is designed to be unobtrusive to patients. LYR-220 is formulated to expand to line the nasal anatomy that had been enlarged as a result of prior surgery. Mometasone furoate (MF), a steroid and the active ingredient in other FDA-approved drugs, is embedded in LYR-220, which is designed to consistently deliver anti-inflammatory medication for six months to the sinonasal passages for treatment of CRS.
We believe this approach has the potential to offer significant benefits to patients who have been on a long journey to find a solution for their CRS. With a sustained therapeutic dose of MF localized at the site of inflammation, the potential exists to improve symptoms for months with a single administration. Having already endured a time-consuming and painful surgery which failed to deliver the relief they sought, patients may now see a light at the end of the tunnel. Administration of LYR-220 via a simple, in-office procedure has the potential to shift the CRS treatment paradigm for post-surgical patients suffering from ongoing disease.
We look forward to making rapid progress with the BEACON LYR-220 clinical trial, which will track safety and feasibility as well as outcomes. Most importantly, we look forward to the day when people struggling with CRS can breathe easier.
