Our PROTECT-1 Clinical Trial in Crohn's Disease

The Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial (PROTECT-1) was designed to demonstrate vercirnon's efficacy as an oral treatment capable of inducing and maintaining clinical response or remission among patients with moderate-to-severe Crohn's disease. This trial was conducted in 17 countries around the world at more than 100 study centers.

PROTECT-1 was a double-blind, randomized and placebo-controlled study. The study enrolled 436 subjects and was intended to provide statistically significant evidence of efficacy.

The PROTECT-1 clinical trial included four separate study periods:

1. A 12-week induction period during which all subjects received either placebo,
   250 mg once daily, 500 mg once daily or 250 mg twice daily of vercirnon.
2. A 4-week active treatment period during which all subjects received vercirnon 250 mg twice daily.
3. A 36-week maintenance period during which all subjects with a 70-point-or-greater drop in Crohn's Disease Activity Index (CDAI) scores at the end of the active treatment period relative to their baseline entry level criteria were re-randomized to either vercirnon 250 mg twice daily or placebo.
4. A 4-week follow-up period during which all subjects were followed for safety while off the drug.

Overall, vercirnon (Traficet-EN™, CCX282 or GSK1605786) in patients with moderate-to-severe Crohn's disease demonstrated evidence of efficacy in both the induction of treatment response as well as the maintenance of remission based on results from the PROTECT-1 study. Furthermore, vercirnon was shown to be well tolerated and safe over the one-year course of this study.

More specifically, data reported from the induction period of the PROTECT-1 trial showed that the 500 mg once-daily dose (QD) of vercirnon in patients with small bowel and/or colonic Crohn's disease was consistently superior to placebo across multiple efficacy endpoints. At week 12, the CDAI ≥ 70-point response was 61 percent in the 500 mg QD group versus 47 percent for placebo (p=0.039). Similarly, the CDAI ≥ 100-point response was 55 percent in this group versus 40 percent for placebo (p=0.029). In addition, colonoscopic evidence of improvement based on the Crohn's Disease Endoscopic Index of Severity (CDEIS) was observed in the 500 mg QD group compared to placebo (CDEIS decrease of -7.2 vs. -0.5 for placebo, p=0.049). C-reactive protein (CRP) results confirmed the effect of 500 mg QD vercirnon.

Furthermore, data from the maintenance period of PROTECT-1 showed that vercirnon treatment was able to maintain the clinical remission rate at 47-50%, whereas the remission rate dropped progressively in the placebo group over the course of the maintenance period. At week 36 of the maintenance period, 47% of patients in the vercirnon group were in remission compared to 31% in placebo (p=0.011).

Finally, safety and tolerability data of vercirnon administered orally for up to 12 consecutive months to subjects in the PROTECT-1 trial showed that vercirnon was safe and well tolerated, with no evidence of immune system compromise.

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