WATERTOWN, Mass. - Lyra Therapeutics, Inc. (NASDAQ:LYRA), a clinical-stage biotech company, announced today that its Phase 3 ENLIGHTEN 1 trial of LYR-210 for chronic rhinosinusitis (CRS) failed to meet its primary endpoint. The trial aimed to demonstrate a statistically significant improvement over a sham control in the composite score of the three cardinal symptoms of CRS at 24 weeks but did not achieve this goal.
The ENLIGHTEN 1 trial is part of a larger program evaluating LYR-210, a bioabsorbable sinonasal implant delivering mometasone furoate, for CRS treatment over six months. Despite the trial's results, LYR-210 was generally well-tolerated with no serious adverse events related to the product. The most common adverse events reported were epistaxis, nasal odor, upper respiratory tract infection, and sinusitis.
During the trial, LYR-210 showed a mean improvement in the 3CS score of 2.13 points, compared to 2.06 points in the sham control group. The intent-to-treat population saw a mean improvement of 2.35 points with LYR-210 versus 1.89 points with sham control. Additionally, a mean improvement in the Sino-Nasal Outcome Test (SNOT-22) score was observed, but ethmoid sinus opacification improvements did not reach statistical significance.
The company's CEO, Maria Palasis, Ph.D., expressed disappointment with the topline results and mentioned that an evaluation of the full dataset is underway to understand the findings and to determine the next steps. This analysis will also inform the ongoing ENLIGHTEN 2 study, the second pivotal Phase 3 trial of LYR-210.
Lyra Therapeutics plans to make near-term operational changes, including a workforce reduction, to preserve cash. The company is expected to release data from the 52-week extension phase of the ENLIGHTEN 1 trial in Q4 2024.
The ENLIGHTEN 1 trial enrolled 190 patients from the U.S. and Europe, randomized 2:1 to receive either LYR-210 or a sham control for 24 weeks. Following this phase, patients in the control group will receive crossover LYR-210 treatment, while those in the LYR-210 group are re-randomized to receive either a crossover sham procedure or repeat treatment with LYR-210.
This news is based on a press release statement from Lyra Therapeutics.
InvestingPro Insights
As the clinical-stage biotech company Lyra Therapeutics faces a setback with its Phase 3 ENLIGHTEN 1 trial, investors may be seeking clarity on the company's financial health and stock performance. According to InvestingPro, Lyra Therapeutics holds more cash than debt on its balance sheet, which could provide a cushion as the company navigates through this challenging period.
InvestingPro data indicates a market capitalization of $245.69 million, underscoring the company's relatively small size in the biotech landscape. The revenue growth for the last twelve months as of Q1 2024 stands at a notable 28.74%, suggesting an underlying potential in the company's operations despite the recent trial results.
However, the stock appears to have been under pressure, with a 1-week total price return of -14.8% and a 1-month total price return of -19.72%, reflecting investor sentiment following the trial's outcome. This aligns with an InvestingPro Tip highlighting that the stock has taken a big hit over the last week.
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