Forte Biosciences Inc. ((FBRX)) announced an update on their ongoing clinical study.
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Forte Biosciences Inc. is currently conducting a Phase 2 clinical study titled A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of FB102 in Adult Participants With Celiac Disease on a Gluten Free Diet. The study aims to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of FB102 in adults with well-controlled celiac disease who undergo an oral gluten challenge. This research is significant as it seeks to provide a new therapeutic option for celiac disease patients who adhere to a gluten-free diet.
The intervention being tested is a biological treatment named FB102, administered in varying doses. The study includes two experimental groups receiving FB102 and one placebo group, with the aim of determining the treatment’s effectiveness in managing celiac disease symptoms.
The study follows a randomized, parallel assignment model with quadruple masking, meaning that participants, care providers, investigators, and outcomes assessors are all blinded to the treatment allocations. The primary purpose of this study is treatment-focused, aiming to establish FB102 as a viable therapeutic option.
The study began on May 13, 2025, with the latest update submitted on August 15, 2025. These dates are crucial as they indicate the study’s current recruiting status and progress towards completion.
From a market perspective, the successful development of FB102 could positively impact Forte Biosciences’ stock performance by positioning the company as a leader in celiac disease treatment. This could also influence investor sentiment positively, especially if FB102 proves to be a breakthrough in managing this condition, potentially affecting competitors in the same therapeutic area.
The study is ongoing, and further details are available on the ClinicalTrials portal.