Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Corporate Update (August 2017)
13 slides from Theravance Biopharma's corporate update, Aug 2, 2017
Slide 1: Forward Looking Statements
Forward Looking Statements 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 results to diff
Slide 2: Gastroparesis Presents a Meaningful Opportunity to Improve Lives of Patients
Gastroparesis Presents a Meaningful Opportunity to Improve Lives of Patients 1 Rey et al., Prevalence of Hidden Gastroparesis in the Community: The Gastroparesis “Iceberg.” J. Neurogastroenterol. Motil., 2012; 18:34-42. Gastroparesis is a severe disease with debilitating symptoms Characterized by de
Slide 3: Velusetrag Well Positioned to Address the Unmet Patient Need in Gastroparesis
Velusetrag Well Positioned to Address the Unmet Patient Need in Gastroparesis 1 Velusetrag is being developed by Theravance Biopharma in collaboration with Alfasigma (AS). AS holds an exclusive option to certain ex-U.S. markets. Theravance Biopharma retains all U.S. rights. 2 Similar results on gast
Slide 4: Study Evaluated Two Distinct Populations
Velusetrag Study Evaluated Two Distinct Populations Enrolled both diabetic and idiopathic gastroparesis patients Design: Randomized, double-blind, and placebo-controlled Phase 2b study Sample size: 232 gastroparesis patients (119 diabetic, 113 idiopathic) Four dose groups: Placebo and 3 doses of vel
Slide 5: Phase 2b Included Two Separate Instruments to Capture Symptom Scores
Velusetrag Phase 2b Included Two Separate Instruments to Capture Symptom Scores 1Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry Draft Guidance July 2015 https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm455645.pdf 2 Neither PRO
Slide 6: 5 mg Showed Greatest Improvement in GCSI Total Score
Velusetrag 5 mg Showed Greatest Improvement in GCSI Total Score (Mean Change from Baseline) * Nominal p-value < 0.05 on difference from placebo 5 mg dose statistically significant (nominal p < 0.05) at weeks 1 – 4 15 and 30 mg doses not statistically significant Lack of dose response resulted in lac
Slide 7: Demonstrated Inverse Dose Response on GCSI Subscale Scores
Velusetrag Demonstrated Inverse Dose Response on GCSI Subscale scores 5 mg dose consistent across all three GCSI domains
Slide 8: 5 mg Showed Greatest Improvement in GRS Total Score
Velusetrag 5 mg Showed Greatest Improvement in GRS Total Score (Mean Change from Baseline) 5 mg dose statistically significant (nominal p < 0.05) at weeks 1 - 4 and at Week 12 Inverse dose response consistent with GCSI (15 and 30 mg not significant) * Nominal p-value < 0.05 on difference from placeb
Slide 9: 5 mg: Consistent Improvement Across All Individual GRS Subscale Scores
Velusetrag 5 mg: Consistent Improvement Across All Individual GRS Subscale Scores Enduring effect of 5 mg with symptom improvement at 4 and 12 weeks
Slide 10: Velusetrag Normalized Gastric Emptying in a Dose Dependent Manner
Placebo (N=23) VEL 5 mg (N=23) VEL 15 mg (N=20) VEL 30 mg (N=21) Patients with Normal Gastric Emptying at Day 28, n (%) 0 (0%) 10 (44%) 13 (65%) 15 (71%) Velusetrag Normalized Gastric Emptying in a Dose Dependent Manner LS Means Day 28 GES % Retention by Hour All doses significantly improve gastric
Slide 11: Generally Well Tolerated with Rates of AEs Comparable to Placebo
Velusetrag 5 mg Generally Well Tolerated with Rates of AEs Comparable to Placebo Higher rates of diarrhea and nausea/vomiting at 15 and 30 mg doses Side effects at higher doses may have blunted symptom benefits Adverse Events Reported at Frequency >5% Placebo (N=59) VEL 5 mg (N=59) VEL 15 mg (N=56)
Slide 12: Phase 2b Study Summary Results
Velusetrag Phase 2b Study Summary Results 5 mg demonstrated statistically significant improvements in gastroparesis symptoms compared to placebo Both PROs: GCSI at 4 weeks and GRS at 4 and 12 weeks1 Both patient sub-types: idiopathic and diabetic gastroparesis Consistent effects in individual sympto
Slide 13: Phase 2b Study Summary Results
Velusetrag Phase 2b Study Summary Results 7” 5 mg demonstrated statistically significant improvements in gastroparesis symptoms compared to placebo Both PROs: GCSI at 4 weeks and GRS at 4 and 12 weeks’ Both patient sub-types: idiopathic and diabetic gastroparesis Consistent effects in individual sym
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