Lyra Therapeutics ( LYRA ), Inc. released results on Monday from the ENLIGHTEN 2 Phase 3 trial of LYR-210 in adult patients with Chronic Rhinosinusitis (CRS).

The ENLIGHTEN 2 trial met its primary endpoint, with LYR-210 demonstrating statistically significant improvement compared to sham control in a composite of the three cardinal symptoms (3CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure) at week 24 (p=0.0078) in patients without nasal polyps.

Also Read: Amgen-AstraZeneca Partnered Asthma Drug Shows Rapid And Sustained Effect In Chronic Rhinosinusitis

The ENLIGHTEN 2 trial also met the key secondary endpoints of 3CS at 24 weeks in the full population (i.e., patients with and without nasal polyps) and in the clinically validated SNOT-22 score at 24 weeks, with symptom improvement observed as early as week 4.

Improvements in SNOT-22 were sustained throughout the trial and were clinically meaningful. More than twice the minimal clinically important difference was observed at week 24 compared to baseline in the LYR-210 group (-22.4 points).

Consistent with previous studies, LYR-210 was well-tolerated, with a safety profile similar to sham control.

Data evaluating computed tomography (CT) scans demonstrated numerical improvement in ethmoid sinus opacification in patients who received LYR-210, compared to sham control at week 20 (-2.15; p=0.1809). These data provide objective radiological evidence of improvement with LYR-210 treatment.

LYR-210 patients showed no difference from sham patients in using corticosteroid rescue medication; however, the LYR-210 patients had fewer endoscopic sinus surgeries than sham control.

LYR-210 was well tolerated, with no product-related serious adverse events in the ENLIGHTEN 2 trial.

The ENLIGHTEN program consists of two Phase 3 trials, ENLIGHTEN 1 and ENLIGHTEN 2, to evaluate the efficacy and safety of LYR-210 for CRS.

While the ENLIGHTEN 2 trial met its primary endpoint and key secondary endpoints, the ENLIGHTEN 1 trial did not meet the primary or secondary endpoints, as reported in May 2024.

Lyra also conducted a pooled data analysis of 64 CRS patients with small nasal polyps (grade 1) from the ENLIGHTEN 1 and ENLIGHTEN 2 trials. The data demonstrated a consistent positive trend compared to sham control over 24 weeks in multiple endpoints:

Improvement in 3CS with LYR-210 compared to sham control at week 24, starting as early as week 4.

Improvement in SNOT-22 score with LYR-210 compared to sham control at week 24, starting as early as week 4.

Improvements in percent ethmoid opacification with LYR-210 compared to sham control at week 20.

Improvements in nasal congestion score (NCS) with LYR-210 compared to sham control at week 24 for patients with moderate to severe NCS at baseline, starting as early as week 4.

Improved nasal polyp score with LYR-210 compared to sham control at week 24.

In March, the Food and Drug Administration (FDA) accepted for review GSK plc's ( GSK ) marketing application for depemokimab in two indications:

Add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterized by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller

Add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

Price Action: LYRA stock is up 411.6% at $25.22 during the premarket session at the last check on Monday.

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