Lyra Therapeutics Presents Positive Full Data Set from LANTERN Phase 2 Study of LYR-210 at COSM 2021 Virtual
New data presented includes:
- First product candidate found to be effective in non-polyp patients in addition to polyp patients in a clinical trial, based on 100% of patients in both groups achieving SNOT-22 MCID at week 24 with LYR-210 (7500µg group) -
- LYR-210 (7500µg) decreased ethmoid opacification at week 24, a measure of disease modification -
- LYR-210 (7500µg) reduced the need for rescue medication -
- Separately, Lyra also reported an analysis showing that LYR-210 (7500µg) achieved statistically significant improvement across 3 cardinal symptoms at week 24 in the LANTERN study -
LYR-210 is an investigational product candidate designed to be administered in-office and to deliver a sustained release therapeutic for up to six months at difficult-to-access nasal inflammation sites, as a non-invasive alternative to surgery for patients who have failed medical management. Lyra reported positive topline data from the LANTERN study in
The COSM oral presentation, titled Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study, contains the full 24-week data set from the company’s Phase 2 clinical trial of LYR-210. Previously unpublished data included: improvement from baseline in bilateral ethmoid Zinreich scores by magnetic resonance imaging (MRI); symptom improvement in both polyp and non-polyp patients; and the need for and use of rescue medication during the trial.
“The data presented today at COSM demonstrates LYR-210’s rapid and durable dose-dependent improvement based on several outcome measures, including the cardinal symptoms of CRS, SNOT-22, and MRI, in both non-polyp and polyp patients, from a single in-office administration,” said Professor
Highlights from the Oral Presentation:
- Polyp vs Non-Polyp Patients: Symptom improvement was observed in both polyp and non-polyp patients, with 100% of patients at the 7500µg dose in each group achieving the minimal clinically important difference (MCID) of 8.9 points for SNOT-22 total score by week 24, with a single administration of LYR-210.
- Sinus Opacification: In the LANTERN study, subjects underwent paranasal sinus MRI at baseline as well as at the end of treatment. LYR-210 achieved improvement in bilateral ethmoid Zinreich scores (an objective measure of sinus opacification) at week 24 in a dose-dependent manner, providing evidence of disease modification, with the 7500µg dose achieving significant improvement compared to control between the two timepoints (p=0.031).
- Rescue Medication: Only 1 patient in the 7500µg group and 2 patients in the 2500µg group required a rescue treatment compared to 7 patients in the control group over the 24-week treatment period. The first incidence of rescue treatment in the control group occurred at week 2, while the only patient to require rescue treatment in the 7500µg group did not require rescue treatment until after week 18. As such, LYR-210 (7500µg) reduced the need for rescue treatment (p=0.048). The need for rescue treatment in the LANTERN study was determined by the treating physician.
Separately, Lyra has shared an analysis of the LANTERN study focused on a composite of three of the cardinal symptoms of CRS.
- Three Cardinal Symptoms: Lyra announced an analysis of a composite score of three cardinal symptoms (3CS) of CRS, which includes nasal blockage, nasal discharge and facial pain, which are the most prevalent symptoms for surgically naïve CRS patients both with and without nasal polyps. With a single administration, LYR-210 (7500µg) achieved statistically significant improvement in the 3CS composite score compared to control at week 24 (p=0.003) and at earlier timepoints.
A clinical presentation of the combined data announced today is available on Lyra’s website.
“We are delighted to present the full data set from our LANTERN study at COSM. I believe today’s data supports LYR-210’s ability to provide up to 24 weeks of effective symptom relief,” said
“Our successful LANTERN study was designed to inform a pivotal Phase 3 trial for LYR-210, and today’s full data set has further shaped our thoughts regarding a preferred design for that trial, subject of course to an End-of-Phase 2 meeting with the FDA,” said Maria Palasis, Ph.D., President and Chief Executive Officer of
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