Phase 3 Trial: LYR-210 for Chronic Rhinosinusitis Shows Mixed Results

Lyra Therapeutics, a biotechnology firm focused on developing therapeutic solutions for chronic rhinosinusitis (CRS), has reported that its Phase 3 ENLIGHTEN 1 trial of LYR-210 did not achieve its primary goal. The trial aimed to show a significant improvement in the composite score of three key symptoms of CRS—nasal obstruction, nasal discharge, and facial pain/pressure—compared to a sham control group after 24 weeks of treatment. However, the results did not reach statistical significance.

The company's President and CEO, Maria Palasis, expressed disappointment with the findings and stated that Lyra is working diligently to analyze the full data set to understand the results better and to determine the next steps. The trial showed some improvements in the 3CS score and the Sino-Nasal Outcome Test (SNOT-22) score for the LYR-210 treatment group compared to the sham control, but these were not statistically significant. Additionally, computed tomography (CT) scans revealed no significant improvement in ethmoid sinus opacification for the LYR-210 group.

Despite the trial's outcome, LYR-210 was found to be generally well-tolerated, with no serious adverse events related to the product. Common side effects included epistaxis, nasal odor, upper respiratory tract infection, and sinusitis. The ENLIGHTEN 1 trial is still ongoing, and results from the 52-week extension phase are anticipated in the fourth quarter of 2024. The second pivotal Phase 3 trial, ENLIGHTEN 2, which also evaluates LYR-210 for CRS, is also in progress.

In light of the trial's results, Lyra Therapeutics anticipates making adjustments to its business operations and reducing its workforce to conserve financial resources.

The ENLIGHTEN 1 trial was a randomized, blinded, sham-controlled study that enrolled 190 patients with CRS who had not responded to medical management and had not undergone ethmoid sinus surgery. The trial's design included a crossover treatment phase and a follow-up period extending to 52 weeks.

LYR-210 is an investigational bioabsorbable sinonasal implant intended to deliver continuous anti-inflammatory medication for six months to treat CRS. CRS is a prevalent inflammatory condition affecting the paranasal sinuses, causing significant discomfort and health issues, and is one of the most common health conditions among people under 65.

Lyra Therapeutics is a clinical-stage company that develops long-acting, anti-inflammatory sinonasal implants to treat CRS. The company's product candidates, LYR-210 and LYR-220, are designed for a simple in-office procedure and aim to provide sustained drug therapy for patients who do not respond to standard treatments. These implants are intended for the approximately four million U.S. patients who fail medical management for CRS each year.