Recent Updates
Recently added Catalysts

LYR-220 Design 1

Phase 2

Chronic Sinusitis | Small molecule | ENT |Lyra Therapeutics, Inc.|Last Updated: Dec 17, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedSHAM_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

LYR-220 Design 1 · 1 trial · 2 indications

Phase 2 1
NCT05035654LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)Chronic Sinusitis
COMPLETED48 Analytics
PHASE2COMPLETED
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
Chronic SinusitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Product-related Unexpected Serious Adverse Events
Through Week 28

Product-related unexpected serious adverse events

Plasma MF Concentrations
Through Week 25

Plasma MF concentrations at 1 hour post study treatment administration and at Days 2 or 3, days 5 or 8, and Weeks 4,12,16 or 20, 24 and 25. The PK analysis will be performed based on subjects with available plasma MF concentration data post Day 1 administration procedure.

Secondary Endpoints

Adverse Events
Through Week 28
Endoscopic Findings
Through Week 25
Ophthalmic Assessment: Intraocular Pressure (IOP)
Through Week 25
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Treatment Arm LYR-220 Design 1EXPERIMENTALBilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
Part 1 and Part 2: Treatment Arm LYR-220 Design 2EXPERIMENTALBilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
Part 2: Treatment Arm Bilateral sham procedure controlSHAM_COMPARATORBilateral sham procedure control

Interventions

NameTypeDescription
LYR-220 Design 1 (Part 1 only)DRUGLYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
LYR-220 Design 2 (Part 1 and Part 2)DRUGLYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
Bilateral sham procedure control (Part 2)DRUGBilateral sham procedure control
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Diagnosis of chronic rhinosinusitis. * Has had a prior bilateral total ethmoidectomy. * Has computed tomography (CT) ethmoid cavity opacification. * Has a Sinonasal Outcome Test (SNOT-22) ≥ 20 at Screening Visit. * Minimum cardinal symptom score. * Has been informed of the nat...

Countries:United StatesAustralia
Unlock Eligibility Criteria

Competitive Landscape -Chronic Rhinosinusitis 11 trials (matched to "Chronic Sinusitis")

Frequently asked questions about LYR-220 Design 1

What is LYR-220 Design 1 used for?

LYR-220 Design 1 is an investigational small molecule being developed for chronic sinusitis, specifically chronic rhinosinusitis in adults. It is delivered locally to the sinuses. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes LYR-220 Design 1?

LYR-220 Design 1 is being developed by Lyra Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker LYRA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with chronic sinusitis.

What phase is LYR-220 Design 1 in?

LYR-220 Design 1 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of chronic sinusitis in adult patients.

What clinical trials is LYR-220 Design 1 in?

LYR-220 Design 1 has one completed Phase 2 clinical trial, the BEACON study (NCT05035654). This trial enrolled 48 adult participants with chronic rhinosinusitis across the United States and Australia. The study was sham-controlled and randomized, though it was not double-blinded.

Is LYR-220 Design 1 the same as LYR-220?

LYR-220 Design 1 is a specific formulation or version of the drug candidate LYR-220. The designation 'Design 1' distinguishes this particular variant in clinical testing. The drug is being developed by Lyra Therapeutics for chronic sinusitis.