Benzinga | Oct 26, 2020 08:32AM EDT

Forte Biosciences, Inc. Announces FDA Has Granted Fast Track Designation To FB-401 For The Treatment Of Atopic Dermatitis



TORRANCE, Calif.--(BUSINESS WIRE)-- Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ:FBRX), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FB-401 for the treatment of atopic dermatitis.

FB-401 is a topically applied live biotherapeutic consisting of specifically selected strains of commensal Roseomonas mucosa and has demonstrated excellent tolerability and significant improvement in atopic dermatitis disease activity in both adults and children in a Phase 1/2a trial which was recently published in Science Translational Medicine.

"We are very appreciative of the decision by the FDA to grant FB-401 Fast Track designation," said Paul Wagner, Ph.D., President and Chief Executive Officer of Forte Biosciences. "We look forward to working closely with the FDA as we accelerate the advancement of FB-401, which has the potential to address a significant unmet need for pediatric and adult patients suffering from atopic dermatitis."

Forte is currently enrolling a trial of FB-401 in atopic dermatitis. For additional information about the trial, see ClinicalTrials.gov using identifier NCT04504279.

About FDA Fast Track

Fast Track is a process designed to facilitate the development and expedite the review of product candidates to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

A drug that receives Fast Track designation is eligible for some or all of the following:

* More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

* More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

* Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

* Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA