Roivant Sciences Ltd. · NASDAQ:ROIV
Roivant Sciences — Technical Presentation (June 2023)
25 slides from Roivant Sciences's technical presentation, June 2023
Slide 1: RVT-3101 TUSCANY-2 Chronic Period Data Presentation
RVT-3101 TUSCANY-2 Chronic Period Data Presentation June 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation includes forward-looking statements that are subject to filings with the U.S. Securities and Exchange Commission, available at substantial risks and uncertainties that could cause actual results to differ www.sec.gov and investor.roivant.com. We operate i
Slide 3: Roivant Has One of the Deepest Immunology Pipelines in the Industry
Roivant Has One of the Deepest Immunology Pipelines in the Industry Seven ongoing registrational trials in multi-billion dollar markets Modality Preclinical Phase 1 Phase 2 Phase 3 Approved Psoriasis | Dermavant Topical ► Atopic Dermatitis | Dermavant Topical Completed RVT-3101 Ulcerative Colitis |
Slide 4: TL1A Blockade is a Unique Mechanism with Broad Potential Application
TL1A Blockade is a Unique Mechanism with Broad Potential Application in Analyses of patient samples from Ph2a TUSCANY study Both Inflammatory and Fibrotic demonstrate impact of RVT-3101 treatment across a broad range of inflammatory and fibrotic biomarkers Diseases Impact of TL1A Blockade TL1A indep
Slide 5: Continued Treatment with RVT-3101 Improves Upon High-End Efficacy Results
Continued Treatment with RVT-3101 Improves Upon High-End Efficacy Results Observed During the Induction Period in TUSCANY-2 Safety and efficacy observed through 56 weeks confirms RVT-3101 potential for best-in-category profile Clinical Remission Endoscopic Improvement (Week 14 → Week 56) (Week 14 →
Slide 6: Two Robust, Positive Studies Conducted By Pfizer To Date
Two Robust, Positive Studies Conducted By Pfizer To Date TUSCANY (Phase 2a) TUSCANY-2 (Phase 2b) • 14-week induction study • 56-week induction and chronic study • IV, single-arm study • SQ, placebo-controlled dose ranging study • Biologic experienced and naïve • Biologic experienced and naïve • Expl
Slide 7: TUSCANY-2 Phase 2b Used a Treat-Through Study Design
TUSCANY-2 Phase 2b Used a Treat-Through Study Design Patients Randomized to One of Nine Arms at Start of Study Induction Period Chronic Period A Placebo, SQ, Q4W RVT-3101 450 mg, SQ, Q4W B RVT-3101 150 mg, SQ, Q4W Screening (up to 6 weeks) and Randomization Placebo, SQ, Q4W C Placebo, SQ, Q4W RVT-31
Slide 8: TUSCANY-2 Phase 2b Used a Treat-Through Study Design
TUSCANY-2 Phase 2b Used a Treat-Through Study Design Patients Randomized to One of Nine Arms at Start of Study Induction Period Chronic Period A Placebo, SQ, Q4W RVT-3101 450 mg, SQ, Q4W B RVT-3101 150 mg, SQ, Q4W Screening (up to 6 weeks) and Randomization Placebo, SQ, Q4W C Placebo, SQ, Q4W RVT-31
Slide 9: Data from Chronic Period of TUSCANY-2
Data from Chronic Period of TUSCANY-2
Slide 10: Patient Disposition in Chronic Period of TUSCANY-2 Phase 2b Study
Patient Disposition in Chronic Period of TUSCANY-2 Phase 2b Study Entered Chronic Period (mITT) mITT is defined as patients who N = 224 received at least one dose of RVT-3101 during the Chronic Period Efficacy data presented here reflect Induction and Chronic Period data for Discontinued treatment,
Slide 11: Baseline Disease Characteristics and Demographics
Baseline Disease Characteristics and Demographics Baseline characteristics are consistent with the Induction Period and reflective of a refractory and difficult-to-treat patient population All Arms Constant Expected N = 224 Ph3 Dose Arm Age (years, mean) 40.8 46.0 Female 40% 28% Weight (kg, mean) 71
Slide 12: At the Expected Phase 3 Dose, Substantial Improvements Across All Key Efficacy Metrics
Constant Expected P3 Dose Arm Any Biomarker Status Biologic Naïve and Experienced At the Expected Phase 3 Dose, Substantial Improvements Were Observed Across All Key Efficacy Metrics with Chronic Dosing Efficacy data from patients assigned Expected P3 Dose throughout study Clinical Remission (Modifi
Slide 13: Greater Improvements with Chronic Dosing in Biomarker Positive Patients
Constant Expected P3 Dose Arm Biomarker Positive Biologic Naïve and Experienced At the Expected P3 Dose, Even Greater Improvements Were Observed with Chronic Dosing in Biomarker Positive Patients Efficacy data from biomarker positive patients assigned Expected P3 Dose throughout study Clinical Remis
Slide 14: Sustained Efficacy Rates Among the Highest Observed in Ulcerative Colitis
Constant Expected P3 Dose Arm Any Biomarker Status Biologic Naïve and Experienced At the Expected Phase 3 Dose, Sustained Efficacy Rates Were Among the Highest Observed in Ulcerative Colitis Efficacy data from patients assigned Expected P3 Dose throughout study Sustained Clinical Remission: Proporti
Slide 15: Strong Results in All Comer Population Maintained in the Chronic Period
All Arms Any Biomarker Status Biologic Naïve and Experienced RVT-3101 Showed Strong Results in All Comer Population that Were Maintained in the Chronic Period Across Endpoints Efficacy data pooled across all nine arms (A through I) Clinical Remission (Modified Mayo) Endoscopic Improvement 45% 45% 40
Slide 16: Biologic-Experienced Biomarker Positive Patients Saw Transformative Outcomes
All Arms Biomarker Positive Biologic Experienced Biologic-Experienced Patients Who Are Biomarker Positive Saw Transformative Outcomes at Completion of Chronic Period Efficacy data pooled across all nine arms (A through I) Clinical Remission (Modified Mayo) Endoscopic Improvement 50% 50% 45% 45% +3%
Slide 17: RVT-3101 Remained Well Tolerated in the Chronic Period
RVT-3101 Remained Well Tolerated in the Chronic Period Topline Safety data: no safety signals; favorable safety profile in Induction Period was maintained in Chronic Period Induction Period Chronic Period (Prior to Week 16) (Weeks 16 to 56) Constant Pbo → Placebo All Drug Arms Exp P3 Dose All Arms E
Slide 18: No Negative Impact of ADAs or NAbs on Efficacy Results
All Arms Any Biomarker Status Biologic Naïve and Experienced No Negative Impact of ADAs or NAbs on Either Short-Term or Long-Term Efficacy Results of RVT-3101 Efficacy data pooled across all nine arms (A through I) Week 56 Clinical Remission Rate by ADA levels 50% 45% 40% 35% 30% 25% 20% 15% 10% 5%
Slide 19: RVT-3101 Results Surpass Data Recently Seen in a Treat-Through Design
Constant Expected P3 Dose Arm Any Biomarker Status + Biomarker Positive Biologic Naïve and Experienced RVT-3101 Results Surpass Data Recently Seen in a Treat-Through Design Recent UC studies have employed a treat-through design, which lacks the selection bias of a “re-randomization design” that serv
Slide 20: RVT-3101 Breaks Through the Monotherapy Barrier
Constant Expected P3 Dose Arm Any Biomarker Status Biologic Naïve RVT-3101 Breaks Through the Monotherapy Barrier Results at Week 56 exceed that seen in recent VEGA combination study which intensively combined an anti-TNF and an anti-IL23 in biologics-naïve patients Efficacy data from biologics-naïv
Slide 21: RVT-3101: Potentially First-in-Class and Best-in-Class
RVT-3101: Potentially First-in-Class and Best-in-Class RVT-3101 PRA-023 TEV-48574 Total Subjects >400 ~225 <100 Dosed (none in IBD) ~250 patients across one ~70 patients Data Induction Data IV and three SQ doses at a single IV dose X Generated >200 patients across three to Date Maintenance Data SQ d
Slide 22: RVT-3101 Leads the Emergence of TL1A Blockade as a New Potential Superclass
RVT-3101 Leads the Emergence of TL1A Blockade as a New Potential “Superclass” of Therapeutics ~$15B Large Market Inflammation-Driven Starts with the transformation Indications of the US IBD market Rheumatoid Arthritis Atopic Dermatitis High-end efficacy combined with a very favorable safety profile
Slide 23: Key Highlights
Key Highlights First-in-class anti-TL1A Antibody, with an efficient, well-validated path to approval • Most comprehensive data set in the class enables deep understanding of dose response and molecule behavior • De-risked and ready for Phase 3 – single dose selected, no IV to SQ translation risk, bi
Slide 24: 2023: Roivant's Biggest Year Yet
2023: Roivant’s Biggest Year Yet Expanded VTAMA ADORING 1 and 2 - RVT-3101 (Anti-TL1A) IMVT-1402 Brepocitinib Coverage and Reach VTAMA Phase 3 UC Phase 2b Data (Next-Gen Anti-FcRn) (TYK2/JAK1) Pivotal Readouts in AD Human Data Trial Readout in SLE Ongoing ✓ ✓ Initial Phase 1 Results Expected Aug/Sep
Slide 25: Thank you.
Thank you. roivant
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