ENV-294 for Asthma

Overseen By Cheryl Sr. Director, Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Enveda Therapeutics

Must be taking: Inhaled corticosteroids, Long-acting beta₂-agonists

Must not be taking: Biologic therapies, Immunosuppressive medications

Disqualifiers: Life-threatening asthma, COPD, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medication called ENV-294 for individuals with moderate to severe asthma. Researchers aim to assess its safety and effectiveness, particularly for those already using inhaled treatments and long-acting medications. Participants will receive either ENV-294 or a placebo (a pill with no active medication) for 12 weeks to monitor its impact on asthma control and lung function. This trial suits adults who have had asthma for at least a year and continue to experience issues despite current treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in asthma care.

Is there any evidence suggesting that ENV-294 is likely to be safe for humans?

Research has shown that ENV-294 has been safe so far. In earlier studies, researchers tested it on healthy individuals, and it was well-tolerated, meaning they didn't experience serious side effects. Participants could take different doses without major problems.

These results are encouraging, especially now that ENV-294 is being tested in individuals with asthma. Although testing for asthma is still in its early stages, the absence of serious side effects in initial trials is promising. However, as this is a new treatment, ongoing studies will help confirm its safety for those with moderate to severe asthma. ^{1 2 3 4 5}

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

Unlike the standard asthma treatments like inhaled corticosteroids or bronchodilators, ENV-294 is unique because it targets a different pathway involved in asthma attacks. This new drug acts on specific receptors in the immune system, potentially reducing inflammation more effectively and with fewer side effects. Researchers are excited because ENV-294 offers a fresh approach that could improve symptom control for patients who don't respond well to existing medications.

What evidence suggests that ENV-294 might be an effective treatment for asthma?

Research has shown that ENV-294, which participants in this trial may receive, might help with asthma by targeting the main causes of airway inflammation. Early studies on atopic dermatitis found that ENV-294 is safe and effective, suggesting potential benefits for asthma as well. In lab tests, ENV-294 performed well for asthma, showing positive results in early experiments. As an oral treatment that is not a steroid, it offers an alternative to common inhalers and steroids. These early indications suggest that ENV-294 could improve asthma control and lung function. ^{1 3 5 6 7}

Who Is on the Research Team?

Gurpreet Ahluwalia, PhD

Principal Investigator

Enveda Therapeutics

Are You a Good Fit for This Trial?

Adults with moderate to severe asthma, who are already using inhaled corticosteroids and long-acting beta₂-agonists, can join this study. They'll be screened for up to 28 days before being randomly assigned to take either the new drug ENV-294 or a placebo daily for 12 weeks.

Inclusion Criteria

Pre-bronchodilator FEV₁ between 50% and 80% of predicted normal at screening and baseline

Able to read, understand, and sign an informed consent form before any study procedures

ACQ-5 score ≥1.25 and ≤3.0 at screening and baseline

Exclusion Criteria

I had a serious asthma attack in the last 4 weeks.

I have had severe asthma attacks that required breathing support.

I had a lung procedure called bronchial thermoplasty within the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive oral ENV-294 or placebo once daily for 12 weeks

12 weeks

Regular visits for safety monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ENV-294

Trial Overview

The trial is testing ENV-294's safety and how well it works compared to a placebo. Participants will have their blood checked for drug levels, and their asthma control and lung function will be monitored through regular visits and assessments over the course of the study.

How Is the Trial Designed?

Group I: ENV-294 Treatment Arm Experimental Treatment 1 Intervention

Participants will be treated with ENV-294 if they are randomized to this treatment arm.

Group II: Placebo Arm Placebo Group 1 Intervention

Participants will be treated with placebo (matching the appearance of ENV-294 active drug) if they are randomized to the placebo arm.

Who Is Running the Clinical Trial?

Enveda Therapeutics

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07301255?term=heart+disease

ENV-294 for Moderate-to-Severe Asthma: A 12-Week ...

This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of ENV-294 in adults ...

2.

firstwordpharma.com

firstwordpharma.com/story/6736874

Enveda Initiates Phase 2 Clinical Trials of ENV-294, a First- ...

Advancement to Phase 2 follows positive interim Phase 1b data in Atopic Dermatitis, demonstrating a robust efficacy and safety profile.

3.

ctv.veeva.com

ctv.veeva.com/study/env-294-for-moderate-to-severe-asthma-a-12-week-study-in-adults

ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in ...

This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of ENV-294 in adults ...

4.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/envedas-first-in-class-env-294-for-asthma-a-breakthrough/

Enveda's First-in-Class ENV-294 for Asthma: A Breakthrough

ENV-294 has already undergone Phase 1 trials in healthy subjects for atopic dermatitis and demonstrated efficacy in preclinical asthma models.

5.

patientcareonline.com

patientcareonline.com/view/atopic-dermatitis-first-now-onto-asthma-for-enveda-s-oral-small-molecule-antiinflammatory-candidate

Atopic Dermatitis First, Now Onto Asthma for Enveda's Oral ...

“ENV-294 has the potential to redefine asthma treatment by targeting key pathways involved in airway inflammation via a non-steroidal, orally ...

6.

biospace.com

biospace.com/press-releases/enveda-initiates-phase-2-clinical-trials-of-env-294-a-first-in-class-oral-therapy-in-atopic-dermatitis-and-asthma

Enveda Initiates Phase 2 Clinical Trials of ENV-294, a First- ...

This study will assess improvements in pulmonary function and safety, marking the first clinical evaluation of ENV-294 in a respiratory ...

7.

firstwordpharma.com

firstwordpharma.com/story/5966986

Enveda Reports Favorable Phase 1 Safety for Novel Oral ...

ENV-294 was found to be well-tolerated with a favorable safety profile across all dose levels, with no dose-limiting toxicities or serious adverse events ...