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
Forte Biosciences, Inc. is a clinical stage, dermatology company developing a live biotherapeutic, FB-401, for the treatment of inflammatory skin diseases. FB-401 has completed Phase 1/2a testing in adult and pediatric (3 years of age and older) patients with atopic dermatitis (AD) and a randomized, placebo-controlled clinical trial in AD patients, 2 years of age and older has been initiated. There is a significant unmet need for safe and effective therapies particularly for pediatric atopic dermatitis patients.
Forward Looking Statements
Forte cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the Company’s current beliefs and expectations. Forward looking statements include statements regarding Forte’s beliefs, goals, intentions and expectations regarding the potential of Fast Track designation to accelerate development and approval of FB-401and achieve potential clinical development milestones in the future. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to Forte’s ability to obtain sufficient additional capital to continue to advance Forte’s product candidates and preclinical programs; uncertainties associated with the clinical development and regulatory approval of Forte’s product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; the risk that interim results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen adverse reactions or side effects may occur in the course of developing and testing product candidates; risks associated with the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and risks related to the impact of the COVID-19 outbreak on Forte’s operations, the biotechnology industry and the economy generally. Information on these and additional risks, uncertainties, and other information affecting Forte's business and operating results is contained in Forte’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission on August 10, 2020 and in its other filings with the Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Forte undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.