LYR-210 for Chronic Sinusitis

(ENLIGHTEN 1 Trial)

No longer recruiting at 59 trial locations

Overseen By Lyra Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Lyra Therapeutics

Must not be taking: Intranasal corticosteroids

Disqualifiers: Severe asthma, Nasal polyps, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new treatment, LYR-210, for individuals with chronic sinusitis, a condition that causes long-term stuffiness and sinus pressure. LYR-210, an implantable drug delivery system, is compared to a placebo to determine its effectiveness in reducing symptoms. This trial may suit those who have experienced chronic sinusitis for an extended period, have tried at least two other treatments without success, and have both sides of the sinus affected. Participants must not have undergone nasal surgery or have severe asthma. As a Phase 3 trial, this study represents the final step before FDA approval, providing an opportunity to access a potentially effective treatment early.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have perennial rhinitis controlled by intranasal corticosteroids, you might not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LYR-210 is generally safe and well-tolerated. During a 24-week treatment period, studies found no major safety issues in patients using LYR-210. The treatment was tested in different doses and remained safe over time. While some patients reported side effects, these were not serious.

This treatment is in an advanced testing stage, indicating that earlier studies have reviewed its safety. These testing phases ensure a treatment is safe enough for large groups of people. Overall, evidence suggests that LYR-210 is a safe option for treating chronic sinusitis. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for chronic sinusitis?

Most treatments for chronic sinusitis, like nasal corticosteroids and saline irrigations, aim to reduce inflammation and manage symptoms. But LYR-210 works differently, delivering a sustained-release formulation of mometasone furoate directly to the sinus tissues over several months. This novel delivery method allows for a steady, localized treatment, potentially reducing the need for daily medication and enhancing patient compliance. Researchers are excited because this approach could provide long-lasting relief from sinusitis symptoms with just a single administration, offering a significant improvement over current treatment options.

What evidence suggests that LYR-210 could be an effective treatment for chronic sinusitis?

Research has shown that LYR-210, which participants in this trial may receive, may effectively treat chronic sinusitis. In an earlier study, patients using LYR-210 experienced significant symptom relief compared to those who received a sham procedure control. The treatment also noticeably reduced inflammation in the nasal passages. Studies suggest that LYR-210 could help people with ongoing nasal problems, including inflammation and growths called polyps. The ENLIGHTEN 2 trial supported these findings by showing clear improvements in patients' conditions. Overall, LYR-210 seems to offer hope for people with chronic sinusitis seeking effective treatment options. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults over 18 with chronic sinusitis, confirmed by CT scan, who've tried at least two medical treatments without success. They must understand the study and consent to participate. Excluded are those with previous nasal surgery, severe allergies well-controlled by steroids, current participation in other studies, pregnancy or breastfeeding women, and various conditions that could interfere with LYR-210 placement or affect survival.

Inclusion Criteria

Agrees to comply with all study requirements

I have tried at least 2 different medical treatments before.

Has been informed of the nature of the study and provided written informed consent

Exclusion Criteria

My doctor thinks I shouldn't join this study.

I have had, am having, or will have an organ transplant or chemotherapy that weakens my immune system.

I have nasal polyps that are moderate to severe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LYR-210 or sham control for 24 weeks

24 weeks

Regular visits for monitoring and assessments

Safety Extension

Participants may continue treatment or crossover to LYR-210 for additional safety monitoring

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Background Therapy
• LYR-210
• Sham procedure control

Trial Overview

The trial is testing LYR-210 against a sham procedure (placebo) for treating chronic sinusitis. Participants will also continue their usual sinus treatments. It's a large-scale phase III study where participants are randomly assigned to treatment groups and don't know which group they're in.

How Is the Trial Designed?

Group I: LYR-210 Experimental Treatment 2 Interventions

Single administration of LYR-210 drug matrix (7500 μg)

Group II: Sham procedure control Placebo Group 2 Interventions

Single mock administration procedure

Background Therapy is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as Ultomiris for:

• Paroxysmal nocturnal hemoglobinuria (PNH)
• Atypical hemolytic uremic syndrome (aHUS)

Approved in United States as Ultomiris for:

• Paroxysmal nocturnal hemoglobinuria (PNH)
• Atypical hemolytic uremic syndrome (aHUS)

Approved in Japan as Ultomiris for:

• Paroxysmal nocturnal hemoglobinuria (PNH)
• Atypical hemolytic uremic syndrome (aHUS)

Who Is Running the Clinical Trial?

Lyra Therapeutics

Lead Sponsor

Trials

5

Recruited

520+

Published Research Related to This Trial

In a study of 66 patients with chronic rhinosinusitis with nasal polyps (CRSwNP), dupilumab significantly reduced symptoms and nasal polyp scores after 6 and 12 months, indicating its effectiveness as a treatment.

The safety profile of dupilumab was favorable, with only 12.7% of patients experiencing injection site reactions and 11.1% having transient hypereosinophilia, suggesting it is a safe option for managing CRSwNP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety Profile of Dupilumab in Chronic Rhinosinusitis with Nasal Polyps: Real-Life Data in Tertiary Care. Galletti, C., Barbieri, MA., Ciodaro, F., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05295459

Efficacy and Safety of LYR-210 for the Treatment ...

This is a 24-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period to evaluate the efficacy and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9292908/

Results of LANTERN Phase 2 randomized controlled study

The treatment effect of LYR‐210 was evaluated over 24 weeks based on patient symptom improvement, reduction in sinonasal inflammation, and reduction in the need ...

3.

investors.lyratherapeutics.com

investors.lyratherapeutics.com/news-releases/news-release-details/lyra-therapeutics-reports-positive-results-enlighten-2-phase-3

News Release - Investor Relations - Lyra Therapeutics, Inc.

The ENLIGHTEN 2 trial met its primary endpoint, with LYR-210 demonstrating statistically significant improvement compared to sham control.

4.

pharmacytimes.com

pharmacytimes.com/view/study-lyr-210-shows-promise-in-chronic-rhinosinusitis-with-nasal-polyps

Study: LYR-210 Shows Promise in Chronic Rhinosinusitis ...

New findings show LYR-210's potential to significantly alleviate chronic rhinosinusitis symptoms, offering hope for patients with nasal inflammation and polyps.

5.

investors.lyratherapeutics.com

investors.lyratherapeutics.com/news-releases/news-release-details/lyra-therapeutics-announces-clinical-plan-lyr-210-and-late

Lyra Therapeutics Announces Clinical Plan for LYR-210 and ...

The 24-week endpoints in the ENLIGHTEN trials assess LYR-210's long-acting therapeutic effect as a bioresorbable sinonasal implant designed to ...

6.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/68/NCT05219968/Prot_000.pdf

Lyra Therapeutics, Inc. Study LYR-210-2021-004

For safety analysis incorporating the safety extension phase, the above safety endpoints will be summarized from Day 1 through Week 48 for the LYR-210 to LYR- ...