Protagonist Therapeutics, Inc. · NASDAQ:PTGX
Protagonist Therapeutics — Corporate Update (August 2018)
10 slides from Protagonist Therapeutics's corporate update, Aug 6, 2018
Slide 1: Phase 2b PROPEL Study in Ulcerative Colitis Patients
PTG-100: Oral, α4β7-specific, GI-restricted, Targeted Therapy for IBD Randomized, double-blind, placebo-controlled adaptive parallel design 12 week induction study, q.d. dosing 2 Phase 2b PROPEL Study in Ulcerative Colitis Patients 300 mg QD Placebo 900 mg QD 150 mg QD Dose B Placebo Dose A Moderate
Slide 2: Human Error in Endoscopy Reads from CRO led to Unusually High Placebo Effect
Human Error in Endoscopy Reads from CRO led to Unusually High Placebo Effect 3 Ruled out operational misconduct or trial design issues as contributing factors to futility Identified central endoscopy read issues early on in the process Interim analysis reads by CRO (n=65) Unusually high placebo remi
Slide 3: PTG-100 has Signals of Clinical Efficacy and Merits further Development
PTG-100 has Signals of Clinical Efficacy and Merits further Development 4 Blinded re-read of full dataset (n=83) by independent CRO (Robarts) Placebo in sync with historic norms (1/21, 4.8%) Clinical efficacy comparable to other competitive IBD drugs (9-16%) Histopathology and PD biomarker analysis
Slide 4: Re-analysis based on Robarts Endoscopy Re-Reads (n = 83)
Re-analysis based on Robarts Endoscopy Re-Reads (n = 83) 5 Dataset Summary Placebo rates decrease to ‘historical norms’ 900 mg q.d. shows signals of clinical efficacy Similar to historical norms of efficacy for IBD drugs (next slide) Blinded endoscopy re-reads on complete data set by Robarts Criteri
Slide 5: Efficacy Similar to Other IBD Targeted Therapy Drugs
PTG-100 Efficacy Similar to Other IBD Targeted Therapy Drugs 6 *Anti-MadCam mAb No central read endoscopy (Entyvio) a4b7 integrin Oral/S1P1 Oral/JAK N= 905 234 132 65 81 43 284 73 225 149 19 21 Injectable Oral Injectable a4b7/aEb7 Injectable MAdCAM 900 mg qd
Slide 6: Final Interim Analysis Conclusions
PTG-100 Phase 2 PROPEL Study A human error in endoscopy reads led to a futile outcome PTG-100 shows signals of clinical efficacy in UC patients Robarts endoscopy re-reads Histopath and PD data Current data warrants further clinical development of PTG-100 7 Final Interim Analysis Conclusions
Slide 7: Recommended for Further Clinical Development
PTG-100 Recommended for Further Clinical Development Further development encouraged by Protagonist, KOLs, and Investors Request an FDA meeting to discuss a Phase 2/3 study Present key findings from Ph 2 PROPEL study at a medical conference 8 Next Steps Stage 1 N = 83 Stage 2 N = 160-180 Ph 2A Ph 2B
Slide 8: Oral, α4β7-specific, GI-restricted, Targeted Therapy for IBD
PTG-100 Oral, α4β7-specific, GI-restricted, Targeted Therapy for IBD 9 Oral Oral, once daily, needle-free, targeted therapy Offers better convenience and compliance Specific Safe Novel Therapy IBD specific mechanism: a4b7 integrin Proven mechanism: mAb Entyvio approved in 2014 GI localized MOA: a4b7
Slide 9: Recent financing reflects investor confidence and provides funding through mid-2020
Corporate Update Recent financing reflects investor confidence and provides funding through mid-2020. 10 2018 PTG-100: Ph2b UC interim Futile Q1 Comprehensive data review completed; Q3 recommended for further development PTG-200: Janssen Ph1 completion 2H Ph2 IND filing for Crohn’s disease Q4 PTG-3
Slide 10: Protagonist's Peptide Assets
Corporate Update 2018 p> Protagonist’s Peptide Assets » PTG-100: 4. Ph2b UC interim > Futile Qi 2. Comprehensive data review completed; Q3 recommended for further development Proprietary Peptide Technology Platform * PTG-200: Janssen 3. Ph1 completion 2H 4. Ph2 IND filing for Crohn's disease Q4 » PT
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