Lyra data on steroid-eluting implant open up 505(b)(2) pathway

Woman blowing nose
Enrollment in a phase 3 program of Lyra Therapeutics' chronic rhinosinusitis treatment is set to begin around the end of the year. (Public Domain Pictures)

Lyra Therapeutics has reported pharmacokinetic data on its mometasone furoate-eluting implantable matrix. The readout advances Lyra’s plans to seek approval for the chronic rhinosinusitis treatment via the 505(b)(2) pathway.

Mometasone furoate, a steroid, is already available in multiple FDA-approved drugs. When given via  a nasal spray, the ingredient is linked to reduced congestion and other positive outcomes, but Lyra thinks it can better those results using a mesh scaffold that releases the drug and an elastomeric matrix that adapts to the patient’s anatomy.

With other products establishing the safety profile of mometasone furoate, Lyra plans to leverage the existing evidence in a submission for approval using the 505(b)(2) pathway. To do so, Lyra needs to create a pharmacokinetic bridge between its formulation and the established dosage forms.

The data reported last week are intended to provide that bridge. Lyra enrolled 24 patients and gave them either a 2500-µg or 7500-µg dose of LYR-210. As the mean maximum plasma concentration of the higher dose was well below the limit established for FDA-approved formulations, Lyra sees the study as supportive of its plans to seek approval via the 505(b)(2) pathway.

Lyra also hailed the trial as providing evidence that LYR-210 can deliver consistent and steady dosing. The plan is to use the results to support the safety of LYR-210 in an anticipated filing that will feature efficacy data from other studies. 

Enrollment in a phase 3 program is set to begin around the end of the year. Lyra is pushing ahead into phase 3 despite a midstage trial missing its primary endpoint. While LYR-210 failed to improve a symptom score at Week 4, a dose-dependent divergence between treatment and control later in the study gave Lyra encouragement to advance the candidate into a phase 3 trial.