BLU-5937 for Chronic Cough

Recruiting in Palo Alto (17 mi)

+95 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Bellus Health Inc. - a GSK company

Disqualifiers: Smoking, COPD, Asthma, Cancer, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called BLU-5937 to see if it can help reduce coughing in adults who have a persistent cough that doesn't get better with usual treatments. The study will measure how often participants cough over a period of several months after taking the medication.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that BLU-5937 for Chronic Cough is an effective drug?

The available research shows that BLU-5937 is effective in reducing coughs in animal models. In guinea pigs, it significantly decreased the number of coughs caused by certain substances, and this effect increased with higher doses. Additionally, BLU-5937 does not affect taste perception, which is a common side effect of similar drugs. This makes it a promising option for treating chronic cough compared to other treatments that might alter taste. ^{1 2 3 4 5}

What safety data is available for BLU-5937 in treating chronic cough?

BLU-5937, also known as camlipixant, is a selective P2X3 receptor antagonist being developed for chronic cough. Preclinical studies have shown that BLU-5937 has excellent tolerability, good oral bioavailability, low predicted clearance in humans, no blood-brain barrier permeability, and a high safety margin. It does not alter taste perception, even at high doses, due to its selectivity for P2X3 receptors over P2X2/3 receptors. BLU-5937 is currently in clinical phase I development, indicating ongoing evaluation of its safety in humans. ^{1 3 4 6 7}

Is the drug BLU-5937 a promising treatment for chronic cough?

Yes, BLU-5937 is a promising drug for chronic cough because it effectively reduces coughing by targeting specific receptors involved in the cough reflex. It is highly selective, meaning it focuses on the right targets without affecting taste, and it has shown strong results in preclinical studies. Additionally, it has good safety and tolerability profiles, making it a strong candidate for treating chronic cough. ^{1 3 4 5 7}

Research Team

Eligibility Criteria

Adults with a persistent cough lasting over a year, not explained by other lung conditions like COPD or asthma, can join this study. They must be non-smokers for at least six months and have no recent infections or history of serious illness like cancer within the past five years.

Inclusion Criteria

I have had a chronic cough for at least one year that hasn't improved with treatment.

I am able to understand and sign the consent form.

I am using effective birth control and will continue for 14 days after my last dose.

Exclusion Criteria

I currently smoke or vape, quit within the last 6 months, or have a 20+ pack-year smoking history.

You have a confirmed case of COVID-19 when you are screened for the study.

I have not had a respiratory infection in the last 4 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BLU-5937 or placebo for 24 weeks to assess efficacy and safety in reducing cough frequency

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment with BLU-5937 long-term

Treatment Details

Interventions

• BLU-5937 (Other)
• Placebo (Other)

Trial Overview The trial is testing BLU-5937, a potential new medication for chronic cough that hasn't responded to other treatments. Participants will either receive BLU-5937 or a placebo (a substance with no active drug) over 24 weeks to compare effectiveness and safety.

Participant Groups

Group I: BLU-5937 50 mg Experimental Treatment 1 Intervention

BLU-5937 oral dose 50 mg twice a day.

Group II: BLU-5937 25 mg Experimental Treatment 1 Intervention

BLU-5937 oral dose 25 mg twice a day.

Group III: Placebo Placebo Group 1 Intervention

Matching Placebo for BLU-5937 oral dose twice a day.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Destin Pulmonary Critical Care, PLLS. Santa Rosa Beach, FL

Accellacare Winston-Salem, NC

Minnesota Lung Center Woodbury, MN

PMG Research of Charlotte, LLC Charlotte, NC

More Trial Locations

Who Is Running the Clinical Trial?

Bellus Health Inc. - a GSK company

Lead Sponsor

Trials

19

Patients Recruited

5,300+

Bellus Health Inc

Lead Sponsor

Trials

16

Patients Recruited

5,300+

Findings from Research

BLU-5937 is a highly selective and potent antagonist of the P2X3 receptor, which plays a key role in the hypersensitization of the cough reflex, making it a promising treatment for chronic cough.

In preclinical studies, BLU-5937 demonstrated significant anti-cough effects in guinea pigs without affecting taste perception, indicating its safety and tolerability, and it is currently in phase I clinical development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BLU-5937: A selective P2X3 antagonist with potent anti-tussive effect and no taste alteration. Garceau, D., Chauret, N.[2020]

In a study involving 23 patients with refractory chronic cough, the P2X3 receptor antagonist filapixant significantly reduced cough frequency and severity, with reductions ranging from 17% to 37% compared to placebo, depending on the dosage.

Filapixant was found to be safe and well-tolerated, with no serious adverse events reported, although taste-related side effects increased with higher doses, affecting up to 57% of patients at the highest dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The P2X3 receptor antagonist filapixant in patients with refractory chronic cough: a randomized controlled trial. Friedrich, C., Francke, K., Birring, SS., et al.[2023]

Eliapixant, a selective P2X3 receptor antagonist, was found to be well tolerated in a study of 47 healthy male volunteers, with low incidence of adverse effects, including taste disturbances, after repeated doses over 2 weeks.

The study demonstrated that eliapixant achieved plasma concentrations sufficient to occupy P2X3 receptors effectively at doses of 200 mg and 750 mg, supporting its potential efficacy for treating refractory chronic cough.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Pharmacodynamics, and Pharmacokinetics of P2X3 Receptor Antagonist Eliapixant (BAY 1817080) in Healthy Subjects: Double-Blind Randomized Study. Friedrich, C., Francke, K., Gashaw, I., et al.[2022]

In a phase 2b trial involving 406 patients with refractory or unexplained chronic cough, sivopixant did not show a statistically significant improvement in 24-hour cough frequency compared to placebo, although the 300 mg dose showed the most promise for reducing cough severity and improving patient-reported outcomes.

The treatment was generally well-tolerated, with mild to moderate adverse effects, particularly taste disturbances, reported in a dose-dependent manner, suggesting that while sivopixant may be effective, further studies are necessary to confirm its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2b Trial of P2X3 Receptor Antagonist Sivopixant for Refractory or Unexplained Chronic Cough. McGarvey, L., Smith, JA., Morice, A., et al.[2023]

In a Phase 1 study involving 36 healthy participants, gefapixant, a P2X3-receptor antagonist for chronic cough, was found to have a safety profile consistent with previous studies, with taste-related adverse events being the most common.

The study highlighted that older adults and females had different pharmacokinetic responses to gefapixant compared to younger males, suggesting that age and sex may influence drug exposure and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 3 Weeks of Orally Administered Gefapixant in Healthy Younger and Older Adults. Nussbaum, J., Hussain, A., Ford, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

BLU-5937: A selective P2X3 antagonist with potent anti-tussive effect and no taste alteration. [2020]

2. England pubmed.ncbi.nlm.nih.gov

The P2X3 receptor antagonist filapixant in patients with refractory chronic cough: a randomized controlled trial. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Safety, Pharmacodynamics, and Pharmacokinetics of P2X3 Receptor Antagonist Eliapixant (BAY 1817080) in Healthy Subjects: Double-Blind Randomized Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

P2X3 receptor antagonist (AF-219) in refractory chronic cough: a randomised, double-blind, placebo-controlled phase 2 study. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2b Trial of P2X3 Receptor Antagonist Sivopixant for Refractory or Unexplained Chronic Cough. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 3 Weeks of Orally Administered Gefapixant in Healthy Younger and Older Adults. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A phase 3, randomized, double-blind, clinical study to evaluate the long-term safety and efficacy of gefapixant in Japanese adult participants with refractory or unexplained chronic cough. [2022]