MTX-463 for Pulmonary Fibrosis

Recruiting at 19 trial locations

Overseen By Jeffrey Bornstein, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mediar Therapeutics

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pulmonary hypertension, Smoking, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 20 weeks

164 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MTX-463, designed to help people with Idiopathic Pulmonary Fibrosis (IPF), a lung disease that makes breathing difficult. Researchers aim to determine the safety and effectiveness of MTX-463 by comparing it to a placebo (a non-active treatment). Individuals diagnosed with IPF within the last seven years, who are either on stable doses of certain IPF medications or have stopped them over 30 days ago, may be suitable candidates. The study seeks to improve IPF management and ultimately enhance patients' quality of life. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

If you are taking pirfenidone or nintedanib, you can continue as long as the dose has been stable for at least 90 days before the study and remains the same during the study. If you stopped these medications, it must have been at least 30 days before the study, and you should not plan to restart them during the study. Other medications may need to be stopped, but the protocol does not specify all details.

Is there any evidence suggesting that MTX-463 is likely to be safe for humans?

Research has shown that MTX-463 was tested in early studies and participants tolerated it well. In one study with healthy volunteers, MTX-463 did not cause any major side effects. This suggests it might be safe for people with idiopathic pulmonary fibrosis (IPF). However, as this treatment remains under investigation, more studies are needed to fully understand its safety. ^{1 2 3 4 5}

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

MTX-463 is unique because it offers a novel approach to treating pulmonary fibrosis by potentially targeting pathways that current medications, like antifibrotics such as pirfenidone and nintedanib, may not fully address. Researchers are excited about MTX-463 because it could provide benefits beyond slowing disease progression, possibly improving lung function or quality of life. This experimental treatment may also offer a more targeted mechanism of action, which could lead to fewer side effects compared to existing therapies.

What evidence suggests that MTX-463 might be an effective treatment for pulmonary fibrosis?

Research shows that MTX-463, which participants in this trial may receive, targets a protein called WISP1, linked to lung fibrosis, or scarring of lung tissue. Previous studies found that blocking WISP1 reduced scarring in animals. This suggests that MTX-463 might slow down or even reverse lung damage in people with idiopathic pulmonary fibrosis (IPF). Early results from similar studies have shown promising signs of improved lung function. However, more research is needed to confirm these findings in humans. ^{1 3 4 6 7}

Who Is on the Research Team?

Pablo Zertuche, MD

Principal Investigator

Mediar Therapeutics

Are You a Good Fit for This Trial?

This trial is for individuals with Idiopathic Pulmonary Fibrosis (IPF), a type of lung scarring. Participants should meet specific health criteria, but the provided information does not detail these requirements.

Inclusion Criteria

Able to understand the study and provide signed, written informed consent

I am 40 or older with idiopathic pulmonary fibrosis.

DLCO of ≥ 25pp at screening

Exclusion Criteria

I don't have any health issues that could affect my study participation.

I have not had a lung infection or taken antibiotics for one in the last 30 days.

I do not have hepatitis B, C, or HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive MTX-463 or placebo by IV infusion every 4 weeks, starting at Day 0 and ending at Week 20

20 weeks

5 visits (in-person)

End of Treatment

End of Treatment Visit occurs 4 weeks after the final infusion

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a final Safety Follow-Up Visit at Week 28

8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MTX-463

Trial Overview The study tests MTX-463 against a placebo in people with IPF. It's a Phase 2a trial, meaning it focuses on the drug's effectiveness and safety. The process is double-blind, so neither participants nor researchers know who receives the actual drug or placebo.

How Is the Trial Designed?

Group I: MTX-463 Experimental Treatment 1 Intervention

MTX-463

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Mediar Therapeutics

Lead Sponsor

Trials

2

Recruited

140+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06967805

NCT06967805 | WISPer: Evaluation of MTX-463 in ... Participants with IPF who meet the study's inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to receive MTX-463 or a matching ...

2. sofinnovapartners.com sofinnovapartners.com/news/mediar-therapeutics-doses-first-patient-in-phase-2-wisper-trial-of-mtx-463-for-idiopathic-pulmonary-fibrosis

Mediar Therapeutics Doses First Patient in Phase 2 ... The first patient has been dosed in its Phase 2 WISPer clinical trial evaluating MTX-463, an investigational therapy for idiopathic pulmonary fibrosis (IPF).

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/mediar-mtx-463/

Mediar commences dosing in Phase II trial of MTX-463 for ... Mediar Therapeutics has dosed the first subject in the Phase II WISPer trial of its investigational therapy, MTX-463, for idiopathic pulmonary fibrosis (IPF).

4. clinicaltrials.eu clinicaltrials.eu/trial/study-of-mtx-463-compared-to-placebo-to-assess-its-safety-and-effectiveness-in-adults-with-idiopathic-pulmonary-fibrosis/

Study of MTX-463 compared to placebo to assess its safety ... Study of MTX-463 compared to placebo to assess its safety and effectiveness in adults with idiopathic pulmonary fibrosis.

5. atsjournals.org atsjournals.org/doi/pdf/10.1164/ajrccm-conference.2024.209.1_MeetingAbstracts.A2476?download=true

Anti-WISP1 (MTX-463) as a Novel Potential Therapy for ... On day 21, fibrotic endpoints were evaluated including lung histology, lung collagen content by hydroxyproline, gene expression, and the levels ...

6. mediartx.com mediartx.com/wp-content/uploads/2024/05/MediarTx_MTX-463-IND-FPD-CAB-Announcement-PR_FINAL_050324_10pm.pdf

Phase 1 study of MTX-463 initiated ... MTX-463 is a first-in-class human IgG1 antibody designed to neutralize WISP-1-mediated fibrotic signaling to address IPF and other fibrotic ...

7. prnewswire.com prnewswire.com/news-releases/mediar-therapeutics-enters-into-global-licensing-agreement-with-lilly-to-advance-first-in-class-wisp1-antibody-for-the-treatment-of-idiopathic-pulmonary-fibrosis-ipf-302347905.html

Mediar Therapeutics Enters into Global Licensing ... The Phase 1 study was recently completed in healthy volunteers and showed MTX-463 to be well-tolerated and engaged WISP1 at all tested doses.