Annuncio • Jul 09
Forte Biosciences Announces Positive Results From FB102 Double-Blind Placebo-Controlled Phase 1b Study In Vitiligo Forte Biosciences, Inc. announced positive results from the FB102 double-blind placebo-controlled phase 1b study in vitiligo. FB102 achieved 29.6% mean FVASI improvement from baseline at week 24 (p-value = 0.020). Response to FB102 was observed early, with statistically significant improvements observed by the day 64 visit (p=0.023), continuing through week 24, after completion of the 12-week treatment period. FB102 achieved 43.2% mean FVASI improvement from baseline at week 24 (p-value = 0.006) in subjects with greater disease involvement having baseline FVASI =0.75 (approximately one-quarter of face depigmented), including: FVASI50 = 58.8%, FVASI75 = 23.5%. Responder endpoints in overall population achieved FVASI50 in 34.4% of FB102 treated subjects at week 24 with FVASI 75 achieved in 12.5% of FB102 treated subjects at week 24; this endpoint was impacted by one placebo FVASI75 responder, reinforcing the importance of randomized controlled studies and baseline severity when interpreting vitiligo responder endpoints. The majority of FB102 treated subjects continued to improve through week 24 after completion of the 12-week treatment period with an additional 8 percentage point FVASI improvement between week 12 and 24. Among FB102-treated subjects with baseline FVASI =0.75 the mean FVASI improvement increased an additional 14 percentage points between week 12 and 24. 84% (27/32) of FB102 treated subjects improved from baseline to week 24 following the 12-week treatment period and 0% (0/32) worsened. 27% (3/11) of placebo subjects worsened during the 24 week period. FB102 continues to demonstrate a strong safety profile and compared favorably to placebo with only mild to moderate AEs. These independent centrally-reviewed, placebo-controlled data demonstrate statistically significant FB102 mean FVASI improvements from baseline, with progressive improvement and a strong responder profile through week 24 after completion of the 12-week treatment period. The FB102 double-blind placebo-controlled phase 1b vitiligo study enrolled 43 subjects 3:1 randomized with 11 on placebo and 32 on FB102. Forte enrolled 2 FB102 treatment cohorts in the trial including the 3 mg/kg maintenance cohort previously disclosed. There were 15 on FB102 in Cohort A and 17 in Cohort B. The primary endpoint of the study was mean percent FVASI improvement from baseline assessed by central-review. The mean percent FVASI improvement from baseline in the ITT population was 29.6% for FB102 (n=32) compared to a mean deterioration of 16.2% for placebo (n=11), for a placebo-adjusted FB102 benefit of 45.8% (p=0.005). The group of 11 placebo subjects in the ITT population had one subject that was not part of the protocol-defined efficacy-evaluable population due to facial hair and that subject also experienced vitiligo progression during the study. The protocol defined efficacy-evaluable population excluded this one placebo subject (n=10) which also provides a more conservative assessment of the FB102 activity. In the protocol-defined efficacy evaluable population (FB102: 32, PBO:10), FB102 achieved 29.6% mean FVASI improvement from baseline at week 24 vs 7.9% on placebo for a placebo-adjusted FB102 benefit of 21.7% (p-value = 0.020). Response to FB102 was observed early, with statistically significant improvement observed by the day 64 visit (p=0.023), continuing through week 24, after completion of the 12-week treatment period. In Cohort A, FB102 achieved a 28.8% mean FVASI improvement from baseline at week 24 compared to 7.9% for placebo for a placebo-adjusted FB102 benefit of 20.9% (p-value = 0.04) while in Cohort B, FB102 achieved a 30.4% mean FVASI improvement from baseline at week 24 compared to 7.9% for placebo for a placebo-adjusted FB102 benefit of 22.5% (p-value = 0.027). In subjects with greater disease involvement having baseline FVASI =0.75 (approximately one-quarter of face depigmented), FB102 achieved 43.2% mean FVASI improvement from baseline at week 24 compared to 0.5% for placebo treated subjects for a placebo-adjusted FB102 benefit of 42.7% (p-value = 0.006) with 10 of 17 FB102 treated subjects achieving an FVASI50 (58.8%) and 4 of 17 achieving an FVASI75 (23.5%) compared to 0 of 4 achieving FVASI50 and FVASI 75 for placebo subjects (0%). In the protocol-defined efficacy evaluable population 11 of 32 FB102 treated subjects achieved FVASI50 (34.4%) with 4 of 32 FB102 treated subjects achieving an FVASI 75 (12.5%) compared to 1 of 10 placebo subjects achieving FVASI50/75; the placebo FVASI75 responder reinforces the importance of randomized controlled studies and baseline severity when interpreting vitiligo responder endpoints. FB102 treated subjects continued to improve through week 24 after completion of the 12-week treatment period with an additional 8 percentage point FVASI improvement between week 12 and 24. Among FB102-treated subjects with baseline FVASI =0.75 the mean FVASI improvement increased an additional 14 percentage points between week 12 and 24. 84% (27/32) FB102 treated subjects improved from baseline to week 24 following the 12-week treatment period and 0% (0/32) worsened. 27% (3/11) of placebo subject worsened during the 24 week period. All AEs were mild/moderate with FB102 comparing favorably to placebo, and taken together with the phase1b celiac study, FB102 continues to demonstrate a strong safety profile. Annuncio • May 02
Forte Biosciences, Inc., Annual General Meeting, May 29, 2026 Forte Biosciences, Inc., Annual General Meeting, May 29, 2026. Annuncio • Apr 10
Forte Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $150.000019 million. Forte Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $150.000019 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,709,936
Price\Range: $26.27
Discount Per Security: $1.5762 Annuncio • Apr 09
Forte Biosciences, Inc. has filed a Follow-on Equity Offering. Forte Biosciences, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock Annuncio • Sep 16
Forte Biosciences, Inc. Announces Presentation of Fb102 Celiac Disease Trial At Tampere Celiac Disease Symposium Forte Biosciences, Inc. announced additional details from the oral presentation "FB102 prevents histological damage and mitigates gluten challenge-induced symptoms in a celiac disease phase 1b study - Jason Tye-Din, Walter and Eliza Hall Institute; Royal Melbourne Hospital" at the Tampere Celiac Disease Symposium 2025 (Tampere, Finland) on September 12, 2025, further supporting the significant differentiation of FB102 in celiac disease. Highlights of the oral presentation include: FB102 demonstrated a decline in the TCR gd density from baseline of 1.5 compared to an increase of 3.9 for placebo (p=0.0007); TCR gd cells produce pro-inflammatory cytokines including IFN-g and TNF-a and upregulate activating receptors on epithelial cells triggering cytotoxic responses that directly kill the epithelial cells. Ki67-positive intraepithelial cell density increased from baseline by 8.6 on placebo compared to 2.5 on FB102 (p=0.0006); Ki67 is a marker of T cell proliferation (inflammation) on gluten exposure in celiac disease; NK cells declined by 95% following FB102 dosing; IL-15 upregulates activating receptors and confers resistance to activation-induced cell death and enhances T cell epithelial cytotoxicity in celiac disease; No statistically significant difference in Tregs between FB102 and placebo at any timepoint; Regulatory T cells (Tregs) help to modulate the immune response in autoimmune diseases like celiac disease. The phase 2 FB102 celiac disease trial is underway with topline data coming in 2026. The FB102 impact on the additional IEL subtypes in the phase 1b trial is extremely encouraging with respect to the additional therapeutic indications Forte is pursuing, including vitiligo and alopecia areata with data from both of these trials expected next year. In some cases, you can identify forward-looking statements by terms such as " may, "will," "should," "plan," "anticipate," "intend," target, project,contemplates," "bel believes,estimates," "predicts," "pot potential" or "continue" or the negatives of these terms or other similar statements are based on the Company's current beliefs and expectations. Forward-looking statements include statements regarding the Company's beliefs, goals, intentions and expectations regarding its product candidate, FB102 and the therapeutic and commercial market potential of FB102, expectations for patient enrollment and timing of clinical data readouts. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: risks related to Forte's ability to obtain sufficient additional capital to continue to advance Forte's product candidate, FB102; uncertainties associated with the clinical development and regulatory approval of Forte's product candidate,FB102, including potential delays in the commencement, enrollment and completion of clinical trials, including the timing of the completion of the Company's patient-based trials; the risk that results from preclinical and any interim result of ongoing clinical trials may not be predictive of future results from clinical trials may not be predictive the failure to realize any value from FB102 in light of inherent risks, expense and difficulties involved in successfully bringing product candidates to market; and additional risks, uncertainties, and other information affecting Forte's business and operating results is contained in Forte's quarterly Report on Forms 10-QQQQQQQ. 
