Business
Forte Biosciences, Inc. Announces Third Quarter 2024 Results and Provides Business Update
DALLAS--(BUSINESS WIRE)-- Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and
About this update from Forte Biosciences, Inc.
[{"type":"text","content":" DALLAS--(BUSINESS WIRE)--\nForte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced third quarter 2024 results and provided a business update.\n\n\nThird Quarter 2024 Business Highlights\n\n\n“We continue to make excellent progress with FB102 and have begun dosing patients in a celiac disease clinical trial. In addition to safety and tolerability, we will be assessing the histological impact as well as a variety of other activity parameters. The topline data is expected to readout in the second quarter of 2025,” said Paul Wagner, Ph.D., Chairman and Chief Executive Officer of Forte Biosciences. “Based on the biology of celiac disease and the mechanism of action of FB102, we are excited about the potential in celiac disease, an indication with a significant unmet need. We believe the data to date supports the significant potential for FB102 across a variety of autoimmune and autoimmune-related diseases with large addressable markets and we look forward to pursuing these opportunities as we continue to advance the FB102 program.”\n\n\nR&D and Clinical Development Summary\n\n\nIn FB102 mechanistic in-vitro studies, human donor T and NK cells were stimulated with either IL2 or IL15 in the presence or absence of FB102. FB102 significantly inhibited proliferation and activation at levels comparable to unstimulated cells. Human donor regulatory T cell (Treg) studies stimulated with IL2 demonstrated comparable proliferation both in the presence and absence of FB102.\n\n\nIn the 4- and 13-week nonhuman primate (NHP) studies, after a single dose, FB102 demonstrated significant reductions in the NK cell pharmacodynamic marker. Additionally, after multiple doses at exposures comparable to human therapeutic doses, Treg levels in the FB102 dosing arm were comparable to vehicle. These observations suggest that FB102 is demonstrating selectivity with respect to inhibiting the intermediate versus high affinity IL2 receptor.\n\n\nThe phase 1 healthy volunteer SAD/MAD cohorts have completed successfully. The FB102 phase 1 healthy volunteer trial demonstrated a good safety profile. Of note, this trial reported a significant reduction in the NK cell pharmacodynamic marker of the FB102 mechanism. Based on these results, Forte has adv...