Forte Biosciences, Inc. (FBRX Quick QuoteFBRX ) 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
Forte Biosciences, Inc. price-consensus-chart | Forte Biosciences, Inc. Quote
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 Quick QuoteSNY ) and Regeneron’s (REGN Quick QuoteREGN ) Dupixent is approved for atopic dermatitis. Incyte (INCY Quick QuoteINCY ) 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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