Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in the clinical trial of FB-401 for the treatment of atopic dermatitis.
The multi-center, placebo controlled clinical trial of FB-401 is expected to enroll approximately 124 pediatric, adolescent and adult subjects aged 2 years of age and older with atopic dermatitis (AD). The primary endpoint of the trial is EASI-50, which is a measure of the proportion of patients that achieve at least a 50% improvement in the atopic dermatitis disease burden as measured by the Eczema Area and Severity Index (EASI).
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.
In the previously completed Phase 1/2a trial, the pediatric cohort enrolled AD patients with mild, moderate and severe disease, ranging in age from 3 to 16 years. Those patients were treated topically with FB-401 for 16 weeks (twice weekly for 12 weeks and every other day for the final 4 weeks). EASI-50 was achieved by 90% of the pediatric patients and 100% of the subset of moderate-to-severe pediatric patients. The mean improvement in the EASI score was 77%, with improvements observed on all actively treated body regions. The activity was durable through the follow-up period of up to 8 months after the end of treatment. Pruritus (itch) also improved by an average of 4 points (mean improvement of 58%). FB-401 has been shown to drive tissue repair and anti-inflammation while controlling potentially harmful bacteria like Staphylococcus aureus.
“We are very excited to be initiating this clinical study,” said Paul Wagner, Ph.D., Chief Executive Officer of Forte Biosciences. “FB-401 has the potential to address a significant unmet need for pediatric and adult patients suffering from atopic dermatitis. Children, in particular have limited treatment options and account for the majority of the approximately 17 million AD patients in the U.S. alone.”
For additional information about the trial, see ClinicalTrials.gov using identifier NCT04504279.
Forte Biosciences, Inc. is a clinical stage, dermatology company developing a live biotherapeutic, FB-401, for the treatment of inflammatory skin diseases. Forte has completed Phase 1/2a testing of FB-401 in pediatric and adult patients (3 years of age and older) 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 on achieving its next level of corporate growth; the ability of the company to continue to advance its product candidates through the development process and 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 the company’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; risks related to the impact of the COVID-19 outbreak on Forte’s operations, and 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.
Source: Forte Biosciences, Inc.
Forte Biosciences, Inc.
Paul Wagner, CEO