Forte (FBRX) Posts Dismal Data on Atopic Dermatitis Candidate
Forte's (FBRX) mid-stage study on its lead candidate FB-401 to address the condition of atopic dermatitis fails to meet its primary goal and the compa...
Forte Biosciences, Inc. FBRX announced that the mid-stage study of its lead product candidate FB-401, which is being evaluated for the treatment of atopic dermatitis, was not successful. Consequently, the company will not advance the study any further.
Shares of this clinical-stage biopharmaceutical company have plunged significantly following the above-mentioned announcement.
FB-401 is a topical live biotherapeutic, which was being developed to treat inflammatory skin diseases
Forte Biosciences, Inc. Price and Consensus
Top-line data from the phase II study of FB-401 failed to meet statistical significance for the primary endpoint of EASI-50 (the proportion of patients with at least 50% improvement in atopic dermatitis disease severity as measured by EASI).
It is important to note that the main goal of EASI-50 was achieved by 58% of the subjects who were administered FB-401 compared with 60% of the enrollees on placebo (p=0.7567).
Nevertheless, positive trends were observed in respect of the key secondary endpoints including EASI-90 with 27.6% of volunteers in the active arm achieving the goal while 20.5% experienced the same in the control arm (p=0.3075).
FB401 was developed in collaboration with the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID). The FDA granted a Fast Track Designation to FB-401 for the treatment of atopic dermatitis.
The company previously reported that it had cash and cash equivalents of $50.8 million as of Jun 30, 2021. It expects to provide investors with an update on its future plans over the next few months.
We note that Sanofi SNY and Regeneron’s REGN Dupixent is approved for atopic dermatitis. Incyte INCY is also evaluating the ruxolitinib cream for the treatment of atopic dermatitis. Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that was designed for a topical application. However, the company announced that the FDA extended the review period for the cream’s New Drug Application (NDA) by three months.
Forte currently has a Zacks Rank #4 (Sell).
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