Hymecromone for Interstitial Lung Disease

Recruiting at 1 trial location

Overseen By Stavros Garantziotis, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Must not be taking: UDP-glucuronosyltransferase inhibitors

Disqualifiers: Lung transplant list, Oxygen at rest, Celiac disease, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

37 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests hymecromone, an experimental treatment, in individuals with interstitial lung disease or lung fibrosis. The researchers aim to determine if this drug can reduce the scarring and thickening of lung tissue that impairs breathing. Participants will take tablets twice daily for 12 weeks and undergo several tests to assess lung function and overall health. Individuals diagnosed with interstitial lung disease or lung fibrosis who can attend multiple clinic visits over 5 months might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain medications that affect liver enzymes or if you have changed your ILD medication dose in the last 3 months.

Is there any evidence suggesting that hymecromone is likely to be safe for humans?

Research has shown that hymecromone is generally safe and well-tolerated in people with interstitial lung disease. One study found that patients with pulmonary arterial hypertension (PAH) and similar lung conditions took hymecromone without experiencing harmful side effects directly linked to the drug.

Although few studies focus specifically on interstitial lung disease, these results suggest hymecromone might be safe for similar lung conditions. Since this trial is in Phase 2, the drug has already passed initial safety tests in humans, indicating it is safe enough for testing with more participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for interstitial lung disease, like corticosteroids and immunosuppressants, aim to reduce inflammation and slow disease progression. But H01, known as Hymecromone, works differently by targeting the production of hyaluronic acid, a substance that can contribute to lung scarring. Researchers are excited because this novel mechanism offers a new way to potentially manage the disease more effectively. Furthermore, Hymecromone is taken orally, which could provide a more convenient option compared to some current treatments that require injections or infusions.

What evidence suggests that hymecromone might be an effective treatment for interstitial lung disease?

Research has shown that hymecromone might lower levels of hyaluronan, a substance linked to lung tissue scarring. Earlier studies found hymecromone to be safe and well-tolerated by patients. While more information is needed, this trial will evaluate the treatment's potential to reduce lung scarring by targeting these harmful substances in the body. The goal is to slow the progression of lung fibrosis in people with interstitial lung disease. ^{1 2 3 4 6}

Who Is on the Research Team?

Stavros Garantziotis, M.D.

Principal Investigator

National Institute of Environmental Health Sciences (NIEHS)

Are You a Good Fit for This Trial?

Adults with progressive interstitial lung disease, including conditions like idiopathic pulmonary fibrosis and other forms of pulmonary fibrosis, are eligible for this trial. Participants must be willing to undergo various tests to measure the effectiveness of H01 in treating their condition.

Inclusion Criteria

I am willing and able to follow the study's procedures for its entire duration.

DLCO>30% <80%, FVC>45% and <80%

I am older than 18 years.

Exclusion Criteria

Known allergy to hymecromone or any component thereof

Physician concern that participant may not adhere to the study protocol

I need extra oxygen when I am resting.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants undergo baseline assessments including blood tests, heart function tests, spirometry, diffusion capacity, resting energy expenditure, and 6-minute walk test

1-2 weeks

1 visit (in-person)

Treatment

Participants take 2 tablets of H01 every morning and 2 tablets every night for 12 weeks. Tests are repeated at study visits.

12 weeks

At least 5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• H01

Trial Overview

The SOLIS study is testing the safety and potential benefits of an oral medication called hymecromone (H01). It aims to see if H01 can lower hyaluronan levels in the blood and improve lung function over a period of 12 weeks.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Adults, male and female with a diagnosis of interstitial lung disease, take 2 doses of 400 mg H01, morning and evening

Who Is Running the Clinical Trial?

National Institute of Environmental Health Sciences (NIEHS)

Lead Sponsor

Trials

294

Recruited

1,233,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12421109/

Randomised, placebo-controlled trial of oral hymecromone ...

Our study shows that oral hymecromone is safe and well tolerated in patients with PAH and PH-ILD. There were no hymecromone treatment-related ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06325696

H01 in Adults With Interstitial Lung Disease (The SOLIS ...

Primary Objective: Evaluate the efficacy of H01 in reducing hyaluronan levels in participants with progressive interstitial lung disease. Secondary Objectives:.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05128929?term=CANTABILINE&rank=1

Study Details | NCT05128929 | Investigation of H01 in ...

This study is a prospective, randomized, double-blind, study of H01 (Hymecromone) in adults with pulmonary hypertension (PH). The primary objective of this ...

4.

delveinsight.com

delveinsight.com/blog/ph-ild-treatment-landscape

PH-ILD Treatment: Expanding Horizons Beyond Prostacyclin

Moreover, their impact on long-term disease outcomes remains modest, as they do not fully address the fibrotic and vascular remodeling processes ...

5.

niehs.nih.gov

niehs.nih.gov/research/atniehs/labs/crb/studies/solis

The SOLIS Study | National Institute of Environmental Health ...

Primary Objective. Evaluate the efficacy of H01 in reducing hyaluronan levels in participants with progressive interstitial lung disease. Secondary Objectives.

6.

withpower.com

withpower.com/trial/phase-2-interstitial-lung-diseases-ild-2-2024-80c67

Hymecromone for Interstitial Lung Disease

This Phase 2 medical study run by National Institute of Environmental Health Sciences (NIEHS) is evaluating whether H01 will have tolerable side effects ...