RVT-3101
January 2023
Forward-Looking Statements
This presentation includes forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned preclinical studies and clinical trials for our products and product candidates, including the information presented in this presentation with respect to RVT-3101 and the potential for RVT- 3101 to improve the treatment of Ulcerative Colitis (UC) and Crohn's Disease (CD) and to be a first-in-class agent, are forward-looking statements.
These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this presentation, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements. The interim data presented here is from the induction period of the TUSCANY-2 study and is based on a interim analysis of key efficacy and safety data, and such data may change following completion of the clinical trial and may not accurately reflect the complete results of the TUSCANY-2 study.
These forward-looking statements will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the sections captioned "Risk Factors" and "Forward-Looking Statements" of our
filings with the U.S. Securities and Exchange Commission, available at www.sec.gov and investor.roivant.com. We operate in a very competitive and rapidly changing environment in which new risks emerge from time to
time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
This presentation includes data, results and attributes for RVT-3101 and certain other products and product candidates generated from separate, independent studies and that do not come from head-to-head analysis. Differences exist between study or trial designs and subject characteristics and caution should be exercised when comparing data across studies. Data regarding other products and product candidates is based on publicly available information.
This presentation also contains estimates and other statistical data made by independent parties and by us relating to data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions, and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.
2
Roivant Has One of the Deepest Immunology Pipelines in the Industry
Eight ongoing registrational trials in multi-billion-dollar markets
Modality
Preclinical
Phase 1
Phase 2
Phase 3
Approved
Psoriasis | Dermavant | Topical | ► | ||||
Atopic Dermatitis | Dermavant | Topical | ► | ||||
RVT-3101 Ulcerative Colitis | New Vant | Biologic | ► | ||||
RVT-3101 Crohn's Diseases | New Vant | Biologic | ► | ||||
BREPOCITINIB Dermatomyositis | Priovant | Small Molecule | ► | ||||
BREPOCITINIB Systemic Lupus Erythematosus | Priovant | Small Molecule | ► | ||||
BREPOCITINIB Other Indications | Priovant | Small Molecule | ► | ||||
BATOCLIMAB Myasthenia Gravis | Immunovant | Biologic | ► | ||||
BATOCLIMAB Thyroid Eye Disease | Immunovant | Biologic | ► | ||||
BATOCLIMAB Chronic Inflammatory Demyelinating Polyneuropathy | Immunovant | Biologic | ► | ||||
BATOCLIMAB Graves' Disease | Immunovant | Biologic | ► | ||||
BATOCLIMAB Warm Autoimmune Hemolytic Anemia | Immunovant | Biologic | ► | ||||
IMVT-1402 Numerous Indications | Immunovant | Biologic | |||||
NAMILUMAB Sarcoidosis | Kinevant | Biologic | ► | ||||
Pipeline reflects both ongoing clinical trials and expected upcoming trials. VTAMA has only received FDA approval for psoriasis, not atopic dermatitis.
- Represents registrational or potentially registrational trials
3
RVT-3101: A Phase 3-ReadyAnti-TL1A Antibody for Ulcerative Colitis, Crohn's
Disease and Other Indications
Statistically Significant and
Clinically Meaningful
Effects Seen in UC Phase 2b
Large and Well-Validated
Market Opportunity
RVT-3101 is First-in-class
with Large Data Set in Hand
Additional
Near-Term Catalyst
Strong Intellectual
Property Position
- High-endefficacy in all-comers population, statistically significant and clinically meaningful benefit at all doses tested
- Response rates enriched in patients positive for a prospectively defined biomarker (~60% of UC patients)
- Favorable safety and tolerability profile
- Both ulcerative colitis and Crohn's disease are large, well-validated commercial markets
- Additional value creation potential expected outside of IBD
- Robust dose ranging work to date: ~300 patients across four dose arms and two studies (including with SQ formulation)
- Efficient Phase 3 program planned with clearly defined path to approval
- Final UC Phase 2b data (TUSCANY-2) expected 1H 2023
- Composition of matter IP protection until 2039+ (including extensions)
- Biologic confers 12 years of regulatory exclusivity following approval
4
Significant Unmet Medical Need
Persists for Patients with IBD
- Affects ~2M people in the US - two most common forms are ulcerative colitis (UC) and Crohn's disease (CD)
- Abdominal pain, bleeding, frequent bathroom visits or constipation, obstruction, and surgery
- Constitutional symptoms of weight loss, fever, and fatigue; significant mental health burden
- Poor prognostic indicators and lack of biomarkers lead to a "trial and error" treatment paradigm or eventual removal of the colon for more severe patients
- Even the best advanced therapies typically result in 10- 15%remission of disease, leaving frequent flare-ups or continued worsening of disease
Ulcerative | Crohn's |
Ulcerative | Crohn's |
Colitis | Disease |
Colitis | Disease |
Source: 2014 Crohn's and Colitis Foundation of America Guidebook; 2019 IBD Global | 5 |
Disease Burden from The Lancet; 2012 Molodecky et al., Gastroenterology | Adapted from https://www.hopkinsmedicine.org/ |
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Roivant Sciences Ltd. published this content on 04 January 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 January 2023 13:37:07 UTC.