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LYR-220 Design 1

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedSHAM_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

LYR-220 Design 1 clinical trials

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

Top 3 of 4 competitors

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Frequently asked questions about LYR-220 Design 1

What is LYR-220 Design 1 used for?

LYR-220 Design 1 is an investigational therapy being studied for chronic sinusitis, including chronic rhinosinusitis. It is a small molecule developed by Lyra Therapeutics, Inc. and has completed a Phase 2 clinical trial in adults with this condition.

Who is developing LYR-220 Design 1?

LYR-220 Design 1 is being developed by Lyra Therapeutics, Inc., a biotechnology company whose common stock trades on the Nasdaq under the ticker symbol LYRA. The company is responsible for the clinical development of this investigational product.

What phase is LYR-220 Design 1 in?

LYR-220 Design 1 is in Phase 2 clinical development. The only reported trial for this asset is a completed Phase 2 study, and no active trials are currently listed. It remains an investigational therapy and has not been approved by the FDA.

What clinical trials is LYR-220 Design 1 in?

LYR-220 Design 1 has been evaluated in one clinical trial: the Phase 2 BEACON study, registered as NCT05035654. Titled "LYR-220 for Adult Subjects With Chronic Rhinosinusitis," the trial enrolled 48 adults, was randomized and sham-controlled, and has been completed.

Is LYR-220 Design 1 the same as LYR-220 Design 1 (Part 1 only)?

Yes, LYR-220 Design 1 is also referred to as LYR-220 Design 1 (Part 1 only). This alternative name may appear in study documentation or discussions, but it refers to the same investigational small molecule for chronic sinusitis.