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STUDY 303

STUDY 303. A Phase III, Randomized, Multi-Center, Open-Label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of Mesalamine Given Once Daily Vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission. Study 303: Objectives. Study design Patient disposition

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STUDY 303

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  1. STUDY 303 A Phase III, Randomized, Multi-Center, Open-Label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of Mesalamine Given Once Daily Vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission

  2. Study 303: Objectives • Study design • Patient disposition • Definitions • Safety of 8-week acute extension • Efficacy of 8-week acute extension • Safety of 12-month long-term extension • Efficacy of 12-month long-term extension • Summary

  3. Study Design of 303 • Open-label, multicenter, phase III study • 12–14-month extension of the Lichtenstein et al. and Kamm et al. studies (parent studies) • Two phases • 8-week acute extension phase • Patients not in remission at the end of the parent studies • Mesalamine 4.8 g/day (given b.i.d.) • 12-month long-term extension phase • Patients in remission at the end of the parent studies or the end of the 8-week acute extension phase • Mesalamine 2.4 g/day (given q.d. or 1.2 g b.i.d.) Adapted from Kamm et al. Gut 2008;57(7):893-902.

  4. Study 303 End Points1 • Primary objective: to assess the long term safety and tolerability of Mesalamine 2.4 g/day over 12 months • Efficacy was not a primary endpoint of Study 303 • Secondary objectives included: • Safety in acute extension phase • Time to relapse in long-term extension phase • Patients in remission at 12 months • Patient satisfaction Adapted from Kamm et al. Poster presented at BSG 20071.

  5. Modified* Ulcerative Colitis-Disease Activity Index * Friability moved from Score of 1 to 2 Adapted from Kamm et al. Gastroenterology 2007;132:66–75.

  6. End Point Definitions • Relapse: Withdrawal from the study due to a requirement for alternative treatment (including a dose increase or surgery) for an exacerbation of UC • Remission: Modified UC-DAI score 1, calculated as a score of 0 for rectal bleeding and for stool frequency, a combined Physician’s Global Assessment (PGA) and sigmoidoscopy score of 1, no mucosal friability, and a sigmoidoscopy score reduction of 1 point or more from baseline Adapted from Kamm et al.2008;57(7):893-902.

  7. Patient Disposition1,2 623 (Parent Studies) 558 (89.6%) (Rolled over into 303) 246 (44%) (Long-term Extension Phase) 312 (56%) (Acute Extension Phase) 213 (68%) 459 (Safety population) (Long-term Extension Phase) 234 (b.i.d. Group) 225 (q.d. Group) Adapted from: 1Kamm et al. Poster presented at BSG 2007.2 Kamm et al. Gut 2008;57(7):893-902.

  8. Efficacy Results: 8-Week Acute Extension Phase

  9. 8-Week Acute Extension Phase: Efficacy Results • Remission • 59.5% of patients in the efficacy population (n=304) achieved remission • Modified UC-DAI score • Mean reduction of 3.9 ± 2.8 points from week 0* to end point • Mean reduction of 5.0 ± 2.7 from parent study baseline to end point • Symptom improvement • 65.1% of patients had a score of 0 for stool frequency at end point compared to 7.9% at week 0 • 80.6% of patients had a score of 0 for rectal bleeding at end point compared to 27.3% at week 0 *Week 0=First study visit of the acute extension phase • Adapted from Lichtenstein GR, et al. Poster presented at ACG, 2007.

  10. Patients in Remission After Eight Weeks’ Extension Therapy Up to 8 weeks’ active treatment Up to 16 weeks’ active treatment (n = 107) (n = 78) (n = 78) (n = 41) Prior treatment

  11. 8-Week Acute Extension Phase:Sigmoidoscopy Scores Number of patients (%) *Week 0=First study visit of the acute extension phase • Adapted from Lichtenstein et al. Poster presented at ACG 2007.

  12. STUDY 303 Acute Extension Phase Conclusions1,2 • Mesalamine 4.8 g/day (2.4 g dosed b.i.d.) was well-tolerated in the 8-week acute extension phase • Safety profile similar to that of the parent studies (Lichtenstein et al. and Kamm et al.) • Mesalamine 4.8 g/day for up to 4 months was well-tolerated • Approximately 60% of patients achieved remission, using stringent clinical and endoscopic criteria Adapted from: 1Lichtenstein et al. Poster presented at APhA 2007.2 Lichtenstein et al. Poster presented at ACG 2007.

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