Slide 1: Izencitinib: Oral gut-selective pan-JAK inhibitor to treat inflammatory bowel diseases
Izencitinib (TD - 1473/JNJ - 8398) Oral gut - selective pan - JAK inhibitor to treat inflammatory bowel diseases August 23, 2021 THERAVANCE BIOPHARMA ® , THERAVANCE ® , the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE ® are registered trademarks of the Theravance Biopharma group of companies
Slide 2: Forward-looking statements
Forward - looking statements 2 Under the safe harbor provisions of the U . S . Private Securities Litigation Reform Act of 1995 , the company cautions investors that any forward - looking statements or projections made by the company are subject to risks and uncertainties that may cause actual resul
Slide 3: Izencitinib Phase 2b induction study in ulcerative colitis
Izencitinib Phase 2b induction study in ulcerative colitis NCT03758443 *Screening was 5 weeks in Japan due to longer wait time for stool test results 3 Week 8 Non - responder Extended Induction Day 1 Week 2 Week 4 Primary Endpoint (n=239) Responder Maintenance Study Day - 28 Screening 4 weeks* Induc
Slide 4: Topline summary
Topline summary ‣ Primary: – No statistically significant difference at any dose in the change in total Mayo score at Week 8 relative to placebo ‣ Key secondary and additional efficacy endpoints at week 8 relative to placebo: – No improvement in clinical remission by adapted Mayo score at any dose –
Slide 5: Change in total Mayo score at week 8
- 1.75 - 2.02 - 2.12 - 2.40 -4 -3 -2 -1 Placebo 20 mg 80 mg 200 mg Treatment Comparison Placebo Adj. Difference (95% CI); p - value 20 mg vs Placebo - 0.27 ( - 1.22, 0.69); p=0.5809 80 mg vs Placebo - 0.37 ( - 1.33, 0.59); p=0.4501 200 mg vs Placebo - 0.65 ( - 1.60, 0.30); p=0.1809 Change in total M
Slide 6: Rates of key secondary endpoints at week 8
Rates of key secondary endpoints at 8 weeks Clinical Remission: by adapted Mayo score components: a stool frequency score of 0 or 1, a rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1. Clinical Response: reduction in total Mayo score ≥ 3 and ≥ 30%, with a reduction in the recta
Slide 7: Rectal bleeding improvement over time
0 20 40 60 80 Day 1 Week 2 Week 4 Week 8 Rectal bleeding improvement (%) over time % of patients with reduction from baseline is calculated based on the number of patients with data available at that visit. 7 % Patients with reduction from baseline Mayo rectal bleeding subscore ≥ 1 Placebo 20 mg 80
Slide 8: Dose-dependent reduction in CRP
Dose - dependent reduction in CRP (median change over time) CRP, C - reactive protein. 8 -1 -0.8 -0.6 -0.4 -0.2 0 0.2 0.4 0.6 0.8 Day 1 Week 2 Week 4 Week 8 mg/L Placebo 20 mg 80 mg 200 mg
Slide 9: Summary of safety results
Summary of safety results ‣ Izencitinib up to 200 mg daily for 8 weeks was well - tolerated ‣ Serious adverse events (n=13) were well balanced amongst the treatment groups and not considered related to study treatment; no deaths ‣ Most TEAEs were mild or moderate – UC exacerbation was slightly more
Slide 10: Topline summary
Topline summary ‣ Primary: – No statistically significant difference at any dose in the change in total Mayo score at Week 8 relative to placebo ‣ Key secondary and additional efficacy endpoints at week 8 relative to placebo: – No improvement in clinical remission by adapted Mayo score at any dose –
Slide 11: Izencitinib program current plan
Analyze data 16 - week extended induction 44 - week maintenance 12 - week induction Based on the ulcerative colitis results, the Company will seek to minimize future expenses associated with the izencitinib program. Izencitinib program current plan 11 Crohn's Disease Phase 2 study Ulcerative Colitis
Slide 12: Q&A Session
Q&A Session Rick E Winningham Chairman and Chief Executive Officer Andrew A. Hindman Senior Vice President, Chief Financial Officer Richard A. Graham Senior Vice President, Development
Slide 13: Theravance Biopharma
Theravance “kX Biopharma A Medicines That Make a Differ;