Topical ENS-002 for Eczema

(EnSync Trial)

No longer recruiting at 2 trial locations

Overseen By Barb Geiger, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Concerto Biosciences

Must be taking: H1 antihistamines

Must not be taking: Immunosuppressives, Antibiotics, Corticosteroids, others

Disqualifiers: Non-AD dermatologic disorders, Immunodeficiency, Malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and effects of a new lotion, ENS-002, for individuals with eczema, specifically atopic dermatitis. ENS-002 contains harmless bacteria that live on the skin and may help improve eczema symptoms. Participants will apply the lotion once or twice daily for up to two weeks, depending on their group. The trial seeks individuals who have had atopic dermatitis for at least six months and experience mild to severe symptoms affecting areas like the neck or hands. As a Phase 1 trial, the research focuses on understanding how ENS-002 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop certain medications before starting ENS-002. For example, you must stop systemic corticosteroids 28 days before, and topical high-potency corticosteroids 28 days before. However, if you're on a stable dose of certain medications like oral or topical H1 antihistamines, you can continue them during the study.

Is there any evidence suggesting that ENS-002 is likely to be safe for humans?

Research has shown that ENS-002 is safe and well-tolerated for people with eczema. In earlier studies, no negative effects related to the drug were reported, indicating that participants did not experience any harmful effects from the treatment itself. The main aim of these studies was to ensure safety, and they achieved this goal. Participants used ENS-002 without any problems, suggesting it is a safe option for treating eczema. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for eczema, which often involve steroids or immunosuppressants, ENS-002 is a topical lotion that targets the skin directly with potentially fewer systemic side effects. Researchers are excited about ENS-002 because it offers a flexible dosing regimen, including both low and high doses applied once or twice daily, catering to different severity levels of eczema. This could mean faster relief and more tailored treatment options for patients with varying degrees of the condition.

What evidence suggests that ENS-002 might be an effective treatment for eczema?

Research has shown that ENS-002, the investigational treatment in this trial, may help treat eczema. Early studies found that people using ENS-002 experienced improvements in their eczema symptoms. This treatment targets a type of bacteria called *Staphylococcus aureus*, which can worsen eczema. Importantly, these studies did not report any side effects related to the drug, suggesting it is safe to use. These findings are promising for those considering participation in clinical trials. ^{1 2 3 4 6}

Who Is on the Research Team?

Bernardo Cervantes, PhD

Principal Investigator

Concerto Biosciences

Are You a Good Fit for This Trial?

This trial is for adults with atopic dermatitis, commonly known as eczema. Participants should have a diagnosis of this skin condition to qualify.

Inclusion Criteria

Able to understand and sign an informed consent form (ICF)

EASI score of 5 to 7 (mild) or 7.1 to 21 (moderate) at screening

I have been diagnosed with atopic dermatitis for at least 6 months.

Exclusion Criteria

Presence of indwelling arterial or venous catheters

Implanted devices/prostheses

Lives with or has frequent contact with individuals with implantable medical devices or severe skin barrier defects

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ENS-002 lotion applied topically once or twice daily depending on cohort for up to 14 days

1-2 weeks

Daily application

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 43 days

What Are the Treatments Tested in This Trial?

Interventions

• ENS-002

Trial Overview The study is testing ENS-002, which is a live biotherapeutic product containing three types of good bacteria. It aims to assess the safety and effects on those with atopic dermatitis.

How Is the Trial Designed?

Group I: ENS-002 Experimental Treatment 1 Intervention

ENS-002 lotion to be applied topically either once or twice per day depending on assigned study cohort. Cohort 1 - once daily dose (QD) of low dose ENS-002. This dose will be applied topically to a single target site once daily for 7 days. Cohort 2 - QD dose of high dose ENS-002 in subjects with mild, moderate or severe Atopic Dermatitis. This dose will be applied topically to all affected skin (excluding scalp, face, groin, genitalia) once daily for 14 days. Cohort 3 - twice daily (BID) dose of high dose ENS-002 in subjects with mild, moderate or severe Atopic Dermatitis applied topically to all affected skin (excluding scalp, face, groin, genitalia) twice daily for 14 days

Who Is Running the Clinical Trial?

Concerto Biosciences

Lead Sponsor

Trials

1

Recruited

9+

Citations

1. biospace.com biospace.com/press-releases/concerto-biosciences-announces-positive-topline-results-from-phase-1b-clinical-trial-of-ens-002-in-patients-with-atopic-dermatitis

Concerto Biosciences Announces Positive Topline Results ... Primary safety endpoint achieved with zero drug-related adverse events; secondary outcomes showed eczema improvement and targeted ...

2. prnewswire.com prnewswire.com/news-releases/concerto-biosciences-announces-positive-topline-results-from-phase-1b-clinical-trial-of-ens-002-in-patients-with-atopic-dermatitis-302596913.html

Concerto Biosciences Announces Positive Topline Results ... Secondary endpoints were positive: eczema symptoms improved, and Staphylococcus aureus (S. aureus)—a bacterium known to increase the frequency ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06469385

Topical ENS-002 for Atopic Dermatitis in Adults This is a Phase 1, open-label, non-randomized, study investigating ENS-002, a live biotherapeutic product (LBP) consisting of commensal, ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/concerto-ens-002-atopic-dermatitis/

Concerto doses first subject in Phase I trial of ENS-002 ENS-002 is being developed for atopic dermatitis by targeting Staphylococcus aureus (S. aureus), which is a key skin inflammation driver.

5. dermatologytimes.com dermatologytimes.com/view/fda-grants-investigational-new-drug-clearance-for-ensemble-no-2-for-phase-1-atopic-dermatitis-trial

FDA Grants Investigational New Drug Clearance for ... Ensemble No.2, or ENS-002, is an investigational live biotherapeutic product first detected by Concerto Biosciences using its kChip ...

6. concertobio.com concertobio.com/solutions/atopic-dermatitis

Atopic Dermatitis Concerto has completed a Phase 1b trial to evaluate ENS-002's safety and mechanism of action in people with atopic dermatitis. To expand to additional skin ...