Study to Evaluate Safety, Tolerability and Efficacy of Oral B-FAHF-2 in Mild-to-Moderate Crohn's Disease
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
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 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 B-FAHF-2 on PBMCs and intestinal mucosa to determine if there
are immunologic alterations that would indicate that controlled efficacy evaluations of
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.