CMTX-101 for Cystic Fibrosis

Recruiting at 22 trial locations

Overseen By Karen McCoy, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Clarametyx Biosciences, Inc.

Must be taking: Inhaled antibiotics

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

41 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CMTX-101, a potential drug for people with cystic fibrosis who are already using antibiotics. The trial aims to determine if this treatment is safe and tolerated by the body. It also examines how the treatment moves through the body and whether it triggers any unwanted immune responses. Participants are divided into groups receiving either the treatment at various doses or a placebo, a harmless substance resembling the treatment. People with cystic fibrosis who experience frequent lung infections and currently use inhaled antibiotics might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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.

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

Research has shown that CMTX-101 is likely safe. In a recent study with 21 participants, the treatment was generally well tolerated, and researchers found no major safety issues. This treatment is a monoclonal antibody that helps break down bacterial layers, making infections easier to treat. Earlier studies, including those involving patients with bacterial pneumonia, also demonstrated that CMTX-101 was safe and tolerable. This evidence suggests that CMTX-101 could be a safe option for people with cystic fibrosis considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cystic fibrosis?

Researchers are excited about CMTX-101 for cystic fibrosis because it offers a potentially novel approach to treating this challenging condition. Unlike most current treatments, which primarily focus on managing symptoms and clearing mucus from the lungs, CMTX-101 may target the underlying causes of cystic fibrosis at a molecular level. This treatment is being tested in varying doses (5 mg/kg, 15 mg/kg, and 30 mg/kg) to determine its optimal efficacy and safety. Such innovation could lead to more effective management of cystic fibrosis, reducing the disease's impact and improving the quality of life for patients.

What evidence suggests that CMTX-101 could be an effective treatment for cystic fibrosis?

Research has shown that CMTX-101 yields promising results in reducing bacterial infections in people with cystic fibrosis. In a recent study, patients treated with CMTX-101 had fewer Pseudomonas aeruginosa, a common bacterium causing lung infections in these patients. The trial will test different dosages of CMTX-101, including 5 mg/kg, 15 mg/kg, and 30 mg/kg, to evaluate its effectiveness. This treatment breaks down the protective layers, called biofilms, that bacteria use to hide from antibiotics. By disrupting these layers, CMTX-101 can enhance the effectiveness of antibiotics. Although still under testing, early results are encouraging. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CMTX-101

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clarametyx.com clarametyx.com/positive-interim-analysis-in-phase-2a-study/

In News Clarametyx Biosciences Announces Positive Interim Analysis in Phase 2a Study Evaluating CMTX-101 for Infections Associated with Cystic Fibrosis.

2. infectiousdiseaseadvisor.com infectiousdiseaseadvisor.com/news/bacterial-biofilm-disrupting-antibody-fast-tracked-for-cystic-fibrosis-patients/

Bacterial Biofilm Disrupting Antibody Fast Tracked for ... Interim findings showed patients (n=21) treated with CMTX-101 saw a reduction in Pseudomonas aeruginosa burden. Additionally, CMTX-101 was found ...

3. clarametyx.com clarametyx.com/clarametyx-biosciences-announces-completion-of-enrollment-in-phase-2a-study-of-cmtx-101-in-cystic-fibrosis/

Clarametyx Biosciences Announces Completion of ... CMTX-101 is currently in a Phase 2 study in cystic fibrosis, with opportunities to expand to other chronic respiratory diseases including ...

4. cidrap.umn.edu cidrap.umn.edu/antimicrobial-stewardship/fda-fast-tracks-antibody-treatment-targeting-bacterial-biofilms

FDA fast-tracks antibody treatment targeting bacterial biofilms The hope is that CMTX-101 can help improve the effectiveness of antibiotic therapies in cystic fibrosis patients. ... CMTX-101 as an ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05629741

NCT05629741 | A 2-Part First-in-Human Study to Evaluate ... The goal of this clinical trial is to assess the safety and tolerability of CMTX-101 in healthy volunteers followed by a similar assessment in patients with ...

6. clarametyx.com clarametyx.com/infections-associated-with-cystic-fibrosis/

Clarametyx Biosciences Announces Progress on Study of ... The company recently concluded an early-stage clinical study of CMTX-101 in community-acquired bacterial pneumonia, generating valuable safety, ...

7. cysticfibrosisnewstoday.com cysticfibrosisnewstoday.com/news/fda-grants-fast-track-designation-cmtx-101-treat-cf-lung-infections/

FDA puts CMTX-101 on fast track for treating CF lung ... Interim data from 21 participants, shared earlier this year, indicated that the therapy was generally well tolerated, with no notable safety ...

8. apps.cff.org apps.cff.org/Trials/Finder?search=%7BPipelineDrugId%3A%2710213%27%2CPipelineDrugDisplayName%3A%27CMTX-101%27%7D

Clinical Trials Finder This study will test the safety and tolerability of a single dose of CMTX-101 delivered through an IV infusion. CMTX-101 is a drug intended to help treat ...