CMTX-101 for Cystic Fibrosis

Recruiting at18 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Clarametyx Biosciences, Inc.

Must be taking: Inhaled antibiotics

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

Stay on Your Current Meds

Trial Summary

What is the purpose of this trial?

CMTX-101 is a bacterial biofilm disrupting monoclonal antibody being developed as an adjunctive therapy to standard of care antibiotics. The goal of this clinical trial is to assess the safety and tolerability of CMTX-101 in people with cystic fibrosis (pwCF). The main questions the study aims to answer are: * Are single doses of CMTX-101 IV infusion safe and tolerated * What is the pharmacokinetic (PK) profile of single doses of CMTX-101 * Do single doses of CMTX-101 induce development of anti-drug antibodies (ADA) and neutralizing antibodies (Nabs)

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must maintain your current chronic antibiotic regimen throughout the study.

What safety data exists for CMTX-101 (also known as CPX) in humans?

In a study with 37 adults with cystic fibrosis, CPX was tested in single doses up to 1,000 mg, and the rate of side effects was similar to those who took a placebo (a harmless pill used for comparison), suggesting it is generally safe. One serious health issue occurred but was not linked to the drug. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

Adults over 18 with confirmed cystic fibrosis can join this trial. They must be able to produce sputum samples, have a lung function of at least 35% or more, and use effective contraception. Participants should also have a recent history of specific antibiotic treatments for P. aeruginosa infection.

Inclusion Criteria

Your lung function is at least 50% (Part 1) or 35% (Part 2) of what is expected for someone your age and size.

I will start inhaled tobramycin about 2 hours before my CAT therapy dose.

I am using or willing to use birth control during and 4 months after the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single IV infusion of CMTX-101 or placebo and are monitored for safety and pharmacokinetics

4 weeks

Multiple visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and pharmacokinetics

5 weeks

Follow-up visits for assessments

Treatment Details

Interventions

• CMTX-101 (Monoclonal Antibodies)

Trial Overview The study is testing CMTX-101, an antibody designed to disrupt bacterial biofilms in cystic fibrosis patients, alongside standard antibiotics. It will check if the drug is safe, how it moves through the body (pharmacokinetics), and if it causes any immune reactions like anti-drug antibodies.

Participant Groups

Group I: 5 mg/kg CMTX-101 Experimental Treatment 1 Intervention

5mg/kg CMTX-101 in 100mL normal saline

Group II: 30 mg/kg CMTX-101 Experimental Treatment 1 Intervention

30 mg/kg CMTX-101 in 100mL normal saline

Group III: 15 mg/kg CMTX-101 Experimental Treatment 1 Intervention

15 mg/kg CMTX-101 in 100mL normal saline

Group IV: Placebo Placebo Group 1 Intervention

Matching placebo, 100mL normal saline

Who Is Running the Clinical Trial?

Clarametyx Biosciences, Inc.

Lead Sponsor

Trials

2

Recruited

70+

Findings from Research

In a phase I trial involving 37 subjects with cystic fibrosis, CPX was found to be safe, with adverse events similar to those in the placebo group, indicating no significant safety concerns for the doses tested.

Despite showing safety, CPX did not demonstrate a significant effect on nasal transepithelial potential difference or sweat chloride levels, suggesting that further investigation is needed to assess its efficacy in treating cystic fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I randomized, multicenter trial of CPX in adult subjects with mild cystic fibrosis. McCarty, NA., Standaert, TA., Teresi, M., et al.[2019]

In a study of 97 participants with cystic fibrosis homozygous for the Phe508del-CFTR mutation, tezacaftor/ivacaftor was found to be generally safe and well tolerated, with a lower incidence of respiratory adverse events compared to placebo (14.0% vs. 21.3%).

Tezacaftor/ivacaftor demonstrated efficacy by providing a mean improvement of 2.7 percentage points in forced expiratory volume (ppFEV1) from baseline, indicating it can be a beneficial treatment option for patients who previously experienced adverse effects from lumacaftor/ivacaftor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tezacaftor/ivacaftor in people with cystic fibrosis who stopped lumacaftor/ivacaftor due to respiratory adverse events. Schwarz, C., Sutharsan, S., Epaud, R., et al.[2022]

Triple combination therapy for cystic fibrosis significantly improves lung function (ppFEV1) and reduces sweat chloride levels compared to placebo and active controls, with mean differences of 13.6% and -44.13, respectively, based on six randomized controlled trials.

The therapy also enhances quality of life as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R) score, showing a mean difference of 19.8% compared to controls, while demonstrating a similar safety profile with no significant increase in adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Triple Combination Cystic Fibrosis Transmembrane Conductance Regulator Modulators in Patients With Cystic Fibrosis: A Meta-Analysis of Randomized Controlled Trials. Wang, Y., Ma, B., Li, W., et al.[2022]

CFTR modulators are expected to significantly improve the health of people with cystic fibrosis by enhancing their baseline condition, slowing lung function decline, and reducing pulmonary exacerbations.

A meeting held by the European Cystic Fibrosis Society emphasized the need for new clinical trial designs to adapt to the rapid advancements in CF treatment, particularly with the introduction of highly effective modulator therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cystic fibrosis drug trial design in the era of CFTR modulators associated with substantial clinical benefit: stakeholders' consensus view. De Boeck, K., Lee, T., Amaral, M., et al.[2021]

Real-world studies indicate that while CFTR modulator therapies for cystic fibrosis are generally well-tolerated, there may be a higher frequency of adverse events (AEs) and discontinuation compared to clinical trials, particularly with lumacaftor/ivacaftor (LUM/IVA) which showed more respiratory-related AEs.

All four CFTR modulators were associated with potential mental health and neurocognitive AEs, highlighting the need for systematic monitoring and the important role of pharmacists in managing these therapies and their side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Safety of CFTR Modulators in the Treatment of Cystic Fibrosis: A Systematic Review. Dagenais, RVE., Su, VCH., Quon, BS.[2022]

References

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

A phase I randomized, multicenter trial of CPX in adult subjects with mild cystic fibrosis. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Tezacaftor/ivacaftor in people with cystic fibrosis who stopped lumacaftor/ivacaftor due to respiratory adverse events. [2022]

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

Efficacy and Safety of Triple Combination Cystic Fibrosis Transmembrane Conductance Regulator Modulators in Patients With Cystic Fibrosis: A Meta-Analysis of Randomized Controlled Trials. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Cystic fibrosis drug trial design in the era of CFTR modulators associated with substantial clinical benefit: stakeholders' consensus view. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Real-World Safety of CFTR Modulators in the Treatment of Cystic Fibrosis: A Systematic Review. [2022]