Clinical Trial of FB-401 For the Treatment of Atopic Dermatitis Fails to Meet Statistical Significance

TORRANCE, CA, USA I September 02, 2021 I Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company, today announced that topline data from its Phase 2 clinical trial of FB-401 for the treatment of atopic dermatitis failed to meet statistical significance for the primary endpoint of EASI-50 (the proportion of patients with at least a 50% improvement in atopic dermatitis disease severity as measure by EASI).

Positive trends were observed in key secondary endpoints including EASI-90 with 27.6% of subjects in the active arm achieving the EASI-90 endpoint compared to 20.5% in the control arm (p=0.3075) and in IGA success (2 point reduction and clear or almost clear) with 38.2% of active subjects achieving success compared to 29.5% in the placebo arm (p=0.2599). The primary endpoint of EASI-50 was achieved by 58% of subjects on FB-401 compared to 60% of subjects on placebo (p=0.7567).

“We are appreciative of the clinical trial sites and the patients for participating in this trial and we are grateful to our investors for taking the risk to support the advancement of a new therapeutic modality for atopic dermatitis,” said Paul Wagner, Ph.D., CEO of Forte Biosciences. “The topline data is disappointing and we will continue to analyze the data; however, given this readout we will not continue to advance FB-401. We expect to provide investors with an update on the future plans for the company over the next several months.”

Forte Biosciences previously reported that it had cash and cash equivalents of $50.8 million as of June 30, 2021.

Given the release of the topline data today, Forte Biosciences will no longer be hosting a conference call on September 7, 2021 as previously announced.

About Forte

Forte Biosciences, Inc. is a clinical-stage, biopharmaceutical company developing a live biotherapeutic, FB-401, for the treatment of inflammatory skin diseases. For more information, please visit www.fortebiorx.com.

SOURCE: Forte Biosciences

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