Forte Biosciences’ Lead Asset Fails in Atopic Dermatitis

 

Shares of Forte Biosciences plunged more than 80% in premarket trading after the company announced that a Phase II atopic dermatitis trial assessing its lead pipeline candidate failed to demonstrate statistical significance in the primary endpoint.

California-based Forte has been assessing FB-401, which consists of three therapeutic strains of a commensal gram-negative bacteria, as a potential treatment for atopic dermatitis. The primary endpoint of Eczema Area and Severity Index (EASI)-50 was achieved by 58% of subjects treated with FB-401 in comparison to 60% of subjects who received placebo.

Although the study failed to reach the endpoint of 50% of patients achieving at least a 50% improvement in disease severity, the company said it did see some positive trends in key secondary endpoints. Those trends include 27.6% of subjects treated with the experimental drug achieving EASI-90, compared to just 20.5% in the control group.

Based on the results of the phase II study, the company plans to discontinue development of FB-401 for this indication. Forte Chief Executive Officer Paul Wagner said the company will provide an update for investors following data analysis of the trial results. Given that, Forte will forego hosting its planned conference call on Sept. 7.

“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,” Wagner said in a statement.

The company had certainly been hopeful regarding FB-401, particularly following Phase I/IIa results in atopic dermatitis among adults and pediatric patients. Data from that study that showed FB-401 demonstrated significant reduction in atopic dermatitis disease and pruritus, the associated itching. Additionally, Forte said the data showed the asset controlled s. aureus while tapering and eliminating steroid use for the treatment of atopic dermatitis.

Wagner thanked the patients who participated in the clinical trials, as well as the researchers at the trial sites. He also thanked the investors who took the “risk to support the advancement of a new therapeutic modality for atopic dermatitis.”

In May, Forte Biosciences reported it had approximately $54.8 million in cash, which it said at the time was sufficient funding for the next 12 months.

Following yesterday’s announcement, the company’s stock fell from its Thursday closing price of $28.59 to $5.55 before the markets opened today.