Forte’s celiac disease drug shows positive results in Phase 1b trial

Published 23/06/2025, 12:26
Forte’s celiac disease drug shows positive results in Phase 1b trial

DALLAS - Forte Biosciences, Inc. (NASDAQ:FBRX), a clinical-stage biotech company with a market capitalization of $96.51 million, reported positive data from a Phase 1b trial of its lead drug candidate FB102 for celiac disease, according to a company press release. According to InvestingPro data, analysts have set price targets ranging from $28 to $61 for the stock.

The trial enrolled 32 subjects who were randomized to receive either FB102 or placebo during a 16-day gluten challenge. Results showed FB102 demonstrated statistically significant benefits on the composite histological VCIEL endpoint compared to placebo (p=0.0099). The positive news has contributed to the stock’s strong performance, with InvestingPro data showing a 20% return over the past year.

The density of CD3-positive T cells decreased by 1.5 in FB102-treated subjects while increasing by 13.3 in placebo subjects (p=0.0035). The drug also showed a 73% improvement in Vh:Cd ratio change compared to placebo.

Patients receiving FB102 experienced 42% fewer gluten challenge-induced gastrointestinal symptoms than those on placebo. No study participants dropped out, and treatment-emergent adverse events were primarily mild with no serious adverse events reported in the FB102 arm.

"Celiac disease is debilitating for many patients with even trace exposure to gluten. FB102 has taken a big step forward towards addressing this very large unmet need," said Paul Wagner, CEO of Forte Biosciences. While the company maintains a healthy current ratio of 5.22, InvestingPro analysis indicates rapid cash burn - a critical factor for investors to monitor as the company advances its clinical programs. Subscribers can access 11 additional ProTips and comprehensive financial metrics for deeper analysis.

The company is now initiating a Phase 2 celiac disease study with topline results expected in 2026. Forte is also conducting a FB102 vitiligo study with results anticipated in the first half of 2026.

FB102 is a proprietary anti-CD122 monoclonal antibody being developed for autoimmune and autoimmune-related conditions.

In other recent news, Forte Biosciences, Inc. announced the results of its annual stockholders’ meeting, which included the election of Class II directors and the ratification of KPMG LLP as the company’s independent registered public accounting firm. The meeting saw significant support, with Richard Vincent, Shiv Kapoor, and David Gryska elected as directors to serve until the 2028 annual meeting. The ratification of KPMG LLP was overwhelmingly supported, receiving 5,285,363 votes in favor. Additionally, Forte Biosciences has scheduled its next annual meeting for May 29, 2025, with detailed information to be provided in upcoming proxy materials. The company also set an April 28, 2025 deadline for stockholders to submit proposals or director nominations for the meeting. This deadline aligns with the standard 10-day period following the meeting announcement. Stockholders planning to solicit proxies for director nominees other than those nominated by the board must also meet this deadline. These developments reflect Forte Biosciences’ ongoing governance activities and adherence to regulatory requirements.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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