Forte Biosciences Inc (NASDAQ:FBRX) recently announced the commencement of dosing in a clinical trial designed to evaluate FB-401 as a therapy for patients suffering from atopic dermatitis.
The dosing announcement for the first patient in the clinical trial represents an important milestone for Forte Biosciences as far as FB-401’s development is concerned. It is a placebo-controlled, multi-center clinical trial that will enroll 124 patients. The study will enroll individuals above 2 years old, which will enroll both children and adult patients.
Forte’s primary endpoint for the FB-401 study is EASI-50. The latter is a measure of the number of patients who will experience at least a 50 percent reduction in the body area affected by atopic dermatitis. The improvement level is measured using the Eczema Area and Severity Index (EASI), thus its use in the primary endpoint name.
“FB-401 has the potential to address a significant unmet need for pediatric and adult patients suffering from atopic dermatitis,” stated Dr. Paul Wagner, the CEO of Forte Biosciences.
FB-401 will target unmet needs, especially for younger patients
Dr. Wagner also pointed out in his statement that Forte Biosciences was excited about launching the study, especially considering the potentially huge benefits that it can deliver to patients. He noted that children suffering from atopic dermatitis usually have limited treatment options, thus focusing on a treatment that will also be useful and safe for children.
There is a huge market for an atopic dermatitis treatment that can cater to patients’ unmet needs. There are roughly 17 million people with atopic dermatitis in the U.S alone and an even bigger patient demography in other markets. FB-401’s commercialization might contribute significantly to Forte’s revenue, especially if it is better than existing atopic dermatitis treatments.
FB-401 is a topical application cream that is made using a particular type of commensal Roseomonas mucosa. The treatment’s previous Phase 1/2a clinical trial yielded favorable results in atopic dermatitis patients that participated in the trial, both children and adults.