Slide 1: IBS-C Phase 2b Results
Exhibit 99.1 IBS-C Phase 2b Results October 2014
Slide 2: Tenapanor Reduces Sodium and Phosphorus Absorption
Tenapanor Reduces Sodium and Phosphorus Absorption WITHOUT TENAPANOR WITH TENAPANOR Dietary Sodium/Phosphorus Passes Diverts Sodium/Phosphorus Into Circulation from Circulation Tenapanor Sodium Sodium Phosphorus Phosphorus Tenapanor is a non-systemic small Local Activity molecule inhibitor of NHE3,
Slide 3: Phase 2b Design for Tenapanor in IBS-C
Phase 2b Design for Tenapanor in IBS-C IBS-C Phase 2b Protocol• Design:Double-blind, placebo-controlled, randomized 1:1:1:1 into three treatment arms, 1 placebo arm (approximately 93 patients/group) for a total of 371 patients;12 weekstreatment, 4 weeksfollow-up • Primary Endpoint: Percent complete
Slide 4: Tenapanor in IBS-C Phase 2b Results: Efficacy
Tenapanor in IBS-C Phase 2b Results: Efficacy • Trial met primary efficacy endpoint: complete spontaneous bowel movement (CSBM) responder [60.7% in tenapanor 50 mg bid group vs. 33.7% placebo; p<0.001] • Theoverallresponderrate for the dual compositeendpoint(CSBMresponder andabdominalpainresponderin
Slide 5: Tenapanor in IBS-C Phase 2b Results: Efficacy (con’t)
Tenapanor in IBS-C Phase 2b Results: Efficacy (con’t) • Doseresponserelationshipwasobservedin the primaryendpoint,aswell as in most other secondary endpoints, although statistical significance was not achieved at the 5 mg or 20 mg doses; activity of tenapanor was maintained throughout entire 12-week
Slide 6: Tenapanor in IBS-C Phase 2b Results: Safety
Tenapanor in IBS-C Phase 2b Results: Safety • Tenapanor well-tolerated across all treatment arms, and there were no serious drug-related adverse events. • Themost commonadverseeventsat 50 mgbid ( 5%)that occurredmore frequently in tenapanor-treated patients compared to placebo-treated patients were
Slide 7: Tenapanor for IBS-C
Tenapanor for IBS-C IBS-C MARKET • Approximately 1.4% of the US population, or 4.4 million individuals, have IBS-C. • About one million patients have been diagnosed LIMITATIONS OF CURRENT TREATMENTS • OTC Drugs Inexpensive but Not Very Effective in Moderate to Severe Cases • Amitiza®and Linzess® Fal
Slide 8: Tenapanor Demonstrates Dose Level and Dose Frequency Response; Stool and Urine Sodium Correlate
Tenapanor Demonstrates Dose Level and Dose Frequency 1 Response; Stool and Urine Sodium Correlate PHASE 1 IN HEALTHY ADULT VOLUNTEERS 50 50 40 40 30 30 20 20 10 10 - - Placebo 3 mg QD 10 mg QD30 mg QD 100 mg Placebo 30mg QD 30mg BID 30mg TID QD 1 RDX5791-102publishedin Spenceret al SciTranslMed 6, 2
Slide 9: Phase 2a Had Demonstrated Activity with QD Dosing
Phase 2a Had Demonstrated Activity with QD Dosing DUAL ENDPOINT: >30% DECREASE IN WEEKLY ABDOMINAL PAIN SCORE AND >1 INCREASE IN CSBM FREQUENCY AS COMPARED TO BASELINE End of Treatment 40% Placebo (n=47) * 100mg QD (n=46) 30% Percent Responders 20% 10% 0% Week 1 Week 2 Week 3 Week 4 Follow-Up Follow
Slide 10: Tenapanor Program – Renal Indications and IBS-C
Tenapanor Program R – enal Indications and IBS-C PHASE 2 PROGRAM INDICATION RESEARCH PHASE 1 2a 2b STATUS Phase 2b Data ESRD-Pi (1) 1H:2015 Phase 2b Data Tenapanor IBS-C (2) Announced (NHE3 Inhibitor) Oct 1, 2014 Phase 2a Data CKD (3) 2H:2015 More information about clinical trials design can be foun