Live News • Jul 12
FB102 Achieves Primary Endpoint in Vitiligo Trial With Durable Improvement at Forte Biosciences Forte Biosciences reported that FB102 met its primary endpoint in a small placebo-controlled vitiligo trial, with statistically significant improvement in facial Vitiligo Area Scoring Index by week 24 and benefits persisting off treatment through week 24.
Experts described the FB102 study as a success but highlighted the need for larger confirmatory trials to better quantify efficacy and fully characterize the safety profile.
Forte Biosciences’ share price is at $43.92, with the stock up 150.1% over the past 30 days, reflecting a sharp recent repricing around the company’s prospects.
The key question now is how future, larger FB102 studies read out, since the current data are early stage and come from a small sample, which can make the stock sensitive to any shift in efficacy or safety signals. New Risk • Jul 09
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 25% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (25% average weekly change). Earnings are forecast to decline by an average of 30% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (100% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$189m net loss in 3 years). Announcement • 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. 
