Lyra Therapeutics Achieves Breakthrough In Chronic Rhinosinusitis Treatment With LYR-210
$LYRA
Lyra Therapeutics, Inc. (Nasdaq:LYRA), a pioneering clinical-stage biotechnology company, recently announced remarkable results from its ENLIGHTEN 2 Phase 3 clinical trial, which evaluated LYR-210, an innovative treatment for chronic rhinosinusitis (CRS). The trial’s success marks a significant milestone in the management of CRS, particularly for patients who have not responded to existing therapies.
In the ENLIGHTEN 2 trial, LYR-210 demonstrated statistically significant improvement over sham control in treating the three cardinal symptoms of CRS—nasal obstruction, nasal discharge and facial pain/pressure—at week 24. The trial achieved its primary endpoint with a p-value of 0.0078 and also showed significant results in key secondary endpoints, including improvements in the Sino-Nasal Outcome Test (SNOT-22) scores, which were observed as early as week 4.
The positive outcomes of the ENLIGHTEN 2 trial contrast with the results from the earlier ENLIGHTEN 1 trial, where LYR-210 did not meet its primary or secondary endpoints. This turnaround in the ENLIGHTEN 2 trial not only underscores the potential of LYR-210 as a viable treatment option but also provides a path forward for regulatory submissions focused on non-polyp CRS patients.
LYR-210 is a bioabsorbable nasal implant that delivers six months of continuous mometasone furoate therapy directly to the sinonasal passages. This method of delivery is particularly advantageous as it allows for sustained treatment exposure, which is critical for managing the chronic nature of CRS. The implant is designed for simple, in-office administration, offering a convenient option for both healthcare providers and patients.
Lyra Therapeutics conducted a pooled data analysis from both the ENLIGHTEN 1 and ENLIGHTEN 2 trials. This analysis included a subset of 64 CRS patients with small nasal polyps and showed a consistent positive trend in multiple efficacy endpoints over 24 weeks. These findings further validate the effectiveness of LYR-210 across a broader CRS patient population. The company plans to continue its dialogue with the FDA to finalize the regulatory pathway for LYR-210.
The upcoming presentation of detailed trial results at the 71st Annual Meeting of the American Rhinologic Society in October 2025 will provide further insights into the impact of LYR-210 on CRS management. The successful outcomes of the ENLIGHTEN 2 trial highlight Lyra Therapeutics’ innovative approach to drug development and its potential to significantly improve the quality of life for patients suffering from chronic rhinosinusitis. The company moves forward with its regulatory strategy, the healthcare community remains optimistic about the future of CRS treatment.
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