Lyra Therapeutics, Inc. (Nasdaq: LYRA), dedicated to advancing treatments for chronic rhinosinusitis (CRS), announced that its Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 did not meet its primary endpoint. The trial aimed to demonstrate a statistically significant improvement over a sham control in treating CRS symptoms, but the results at 24 weeks fell short of expectations.

The ENLIGHTEN 1 trial is one of two critical Phase 3 studies examining the efficacy of LYR-210, a bioabsorbable sinonasal implant designed to deliver six months of continuous treatment for CRS. Despite the setback, the trial revealed some improvements in patient symptoms that did not reach statistical significance:

– In the primary efficacy analysis, LYR-210 showed a mean improvement in the composite score of three cardinal symptoms (3CS) of 2.13 points versus 2.06 points for the sham control.

– The intent-to-treat (ITT) population saw a mean improvement of 2.35 points with LYR-210 compared to 1.89 points in the sham group.

– LYR-210 participants also experienced a mean improvement of 20.2 points in the Sino-Nasal Outcome Test (SNOT-22) score, compared to 15.70 points for sham controls.

Despite these findings, improvements in ethmoid sinus opacification, evaluated by computed tomography (CT) scans, did not achieve statistical significance. LYR-210 was generally well-tolerated, with no serious product-related adverse events reported. Common adverse events included epistaxis, nasal odor, upper respiratory tract infection, and sinusitis.

Maria Palasis, Ph.D., President and CEO of Lyra Therapeutics, expressed disappointment in the results: “We are surprised and disappointed by the ENLIGHTEN 1 topline results. We are moving as quickly as possible to evaluate the full dataset to better understand these findings in order to determine our path forward.”

The ENLIGHTEN 1 trial continues, with data from the 52-week extension phase expected in Q4 2024. Meanwhile, the ENLIGHTEN 2 trial remains ongoing, reflecting the company’s ongoing commitment to exploring the potential of LYR-210.

In response to the trial results, Lyra Therapeutics is planning near-term changes to its business operations, including a workforce reduction to preserve cash. These changes are crucial as the company navigates the implications of the trial outcomes and plans its next steps.

The results of the ENLIGHTEN 1 trial underscore the complex nature of treating chronic rhinosinusitis, a condition that significantly affects millions annually. While the trial’s primary endpoints were not met, the data collected will provide valuable insights that could lead to improved treatment options in the future. Lyra Therapeutics’ commitment to reevaluating and pushing forward reflects the resilience often required in pharmaceutical research and development.

  chronic rhinosinusitis treatment, clinical trial results, ENLIGHTEN 1 trial, LYR-210, Lyra Therapeutics, Pharmaceutical Industry News