Oral E-B-FAHF-2 for Crohn's Disease

Recruiting in Palo Alto (17 mi)

Overseen by David Dunkin

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: CAM products, CYP3A alterers

Disqualifiers: Severe disease, Autoimmune, Neoplasm, others

Trial Summary

What is the purpose of this trial?

Crohn's disease (CD) is the major form of inflammatory bowel disease (IBD) affecting adults. It is a life-long disease characterized by chronic and relapsing inflammation of the gastrointestinal tract. CD has multiple clinical phenotypes and disease severities that determine which therapy the study team utilizes. Currently, there are numerous treatment options for subjects with moderate-severe CD, but few that are approved to treat and maintain remission for the one-third of patients who present with mild-to-moderate disease. The study team hypothesizes that Butanol Purified Food Allergy Herbal Formula-2 (B-FAHF-2) will be safe and effective for maintaining remission of mild-to-moderate CD and can fill this therapeutic void. CD affects 241 per 100,000 adults in the United States and the incidence in both adults and children has increased in the past 60 years. One such potential therapy is Food Allergy Herbal Formula-2 (FAHF-2) which was originally developed to treat food allergy and has received FDA investigational new drug approval under the botanical drug title for treating patients with multiple food allergies. A completed phase I study showed that FAHF-2 is safe and well tolerated. A Phase II trial revealed that a high pill burden with FAHF-2 caused poor compliance. A butanol purified form of FAHF-2 (B-FAHF-2) is a more concentrated form of FAHF-2 which has also received an IND (FDA IND#77,468) and reduces the pill burden and improves compliance. Interestingly, the herbal components in B-FAHF-2 have long been used in Traditional Chinese Medicine (TCM) to treat gastrointestinal disorders including colitis. The study team has shown that B-FAHF-2 non-toxically inhibits TNF-#, a major inflammatory cytokine involved in CD, as well as multiple other pro-inflammatory cytokines produced by human peripheral blood mononuclear cells (PBMCs) and intestinal mucosa from subjects with CD. In addition, the study team has shown that FAHF-2 prevents disease progression in a murine model of colitis. The study team hypothesizes that E-B-FAHF-2 will be safe and effective for treating mild-to-moderate CD and can fill this therapeutic void. The study team proposes to investigate the safety and tolerability of B-FAHF-2 in subjects with mild-to-moderate CD. The goal is to establish safety and tolerability and explore efficacy at maintaining remission in this select patient population. Importantly, the study team will also determine the immunotherapeutic effects of E-B-FAHF-2 on PBMCs and intestinal mucosa to determine if there are immunologic alterations that would indicate that controlled efficacy evaluations of E-B-FAHF-2 are warranted. The new IND number is 143453. The FDA has completed their safety review of this protocol and has concluded that the study team's clinical trial may proceed with the proposed clinical investigation for Crohn's disease.

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 use any complementary and alternative medicine (CAM) products or medications that alter CYP3A function.

What data supports the effectiveness of the treatment E-B-FAHF-2 for Crohn's Disease?

The treatment E-B-FAHF-2, derived from Food Allergy Herbal Formula-2 (FAHF-2), has shown effectiveness in reducing peanut-induced allergic reactions in animal studies and has been safe and well-tolerated in humans with food allergies. Although this data is related to food allergies, it suggests potential immune-modulating benefits that might be relevant for Crohn's Disease.

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What makes the treatment E-B-FAHF-2 unique for Crohn's Disease?

E-B-FAHF-2 is unique because it is based on traditional Chinese medicine and has been refined to reduce the pill-load, making it more suitable for clinical studies, especially in children. It contains berberine, a bioactive component that has shown immune-modulating effects in other conditions like food allergies.

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Eligibility Criteria

Adults aged 18-30 with recently diagnosed mild-to-moderate Crohn's disease, able to undergo endoscopy and colonoscopy. Participants must be in good health, able to swallow pills, immunized per CDC guidelines, and if female and of childbearing potential, using effective birth control. Exclusions include severe CD cases, abnormal organ function tests, concurrent strong medication interactions, other systemic diseases or experimental therapy within the last month.

Inclusion Criteria

I am between 18-30 years old with Crohn's disease and generally healthy.

I weigh at least 25kg.

Either an elevated fecal calprotectin or an elevated CRP.

Exclusion Criteria

I haven't taken steroids, immunomodulators, or biologic medications in the last six months.

My liver tests are higher than normal.

Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3).

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Induction

Subjects are induced with Entocort EC for 8 weeks to assess response before enrollment in the trial

8 weeks

4 visits (in-person), phone contacts in between

Safety and Tolerability

Double blind, placebo controlled dose escalation trial of E-B-FAHF-2 in subjects who responded to induction therapy

8 weeks

4 visits (in-person), phone contacts in between

Open-label Extension

Exploratory extension trial of E-B-FAHF-2 monotherapy to ensure sub-chronic safety and assess efficacy

6 months

6 visits (in-person), 1 PK study visit for a subset of subjects

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The trial is testing E-B-FAHF-2 (a concentrated herbal formula) against a placebo for safety and effectiveness in maintaining remission of mild-to-moderate Crohn's disease. The study will also examine the effects on immune cells and intestinal mucosa to assess whether further efficacy trials are warranted.

Group I: E-B-FAHF-2 Experimental Treatment 1 Intervention

Low dose EBFAHF-2 (29 mg/kg/d divided two times a day) for 2 weeks followed by a full dose (71mg/kg/d divided two times a day) for 6 weeks

Group II: Placebo Placebo Group 1 Intervention

capsules are identical in appearance to EBFAHF-2 capsules

BFAHF-2 is already approved in United States for the following indications:

🇺🇸 Approved in United States as B-FAHF-2 for:

• Investigational for Crohn's disease

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Icahn School of Medicine at Mount Sinai New York, NY

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai Lead Sponsor

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Berberine as a chemical and pharmacokinetic marker of the butanol-extracted Food Allergy Herbal Formula-2. [2017] Food Allergy Herbal Formula-2 (FAHF-2) provided protection against peanut anaphylaxis in a murine model and induced beneficial immune-modulation in humans. Butanol-refined FAHF-2, B-FAHF-2, retained safety and efficacy in the peanut allergic murine model at only 1/5 of FAHF-2 dosage. One compound, berberine, was isolated and identified in vitro as a bioactive component present in FAHF-2 and B-FAHF-2. The aim of this study was to investigate berberine as a chemical and pharmacokinetic marker of B-FAHF-2.

2. United States pubmed.ncbi.nlm.nih.gov

Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy. [2023] Food Allergy Herbal Formula-2 (FAHF-2) is a 9-herb formula based on traditional Chinese medicine that blocks peanut-induced anaphylaxis in a murine model. In phase I studies FAHF-2 was found to be safe and well tolerated.

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of food anaphylaxis with traditional Chinese herbal remedies: from mouse model to human clinical trials. [2021] To describe the development of a novel treatment for food allergy, named the food allergy herbal formula-2 (FAHF-2), that is based on traditional Chinese medicine.

4. United States pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and immunologic effects of a food allergy herbal formula in food allergic individuals: a randomized, double-blinded, placebo-controlled, dose escalation, phase 1 study. [2021] Food allergy is a common and serious health problem. A new herbal product, called food allergy herbal formula 2 (FAHF-2), has been demonstrated to have a high safety profile and potent long-term efficacy in a murine model of peanut-induced anaphylaxis.

5. England pubmed.ncbi.nlm.nih.gov

Efficacy, safety and immunological actions of butanol-extracted Food Allergy Herbal Formula-2 on peanut anaphylaxis. [2021] Therapies for peanut allergy (PNA) are urgently needed. Food Allergy Herbal Formula-2 (FAHF-2) has profound therapeutic effects in a murine PNA model and is safe for food-allergic adults in clinical trials. However, the large FAHF-2 pill-load is not conducive to clinical studies in children. Thus, refining FAHF-2 to decrease pill-load is essential for the inclusion of children in clinical trials and to facilitate studying FAHF-2 as a clinically useful botanical drug.

6. United States pubmed.ncbi.nlm.nih.gov

Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study. [2022] Food allergy is a common and increasing health concern in westernized countries. No effective treatment is available, and accidental ingestion can be life-threatening. Food Allergy Herbal Formula-2 (FAHF-2) blocks peanut-induced anaphylaxis in a murine model of peanut-induced anaphylaxis. It was found to be safe and well tolerated in an acute phase I study of patients with food allergy.