Infant Bacterial Therapeutics Ab Class B · OMXSTO:IBT_B
Infant Bacterial Therapeutics Ab Class B — Pareto Securities Health Care Conference 2017
34 slides from Infant Bacterial Therapeutics Ab Class B's conference presentation, September 2017
Slide 1: Infant Bacterial Therapeutics
Infant Bacterial Therapeutics Pareto Securities Health Care Conference September 2017 1
Slide 2: Disclaimer
Disclaimer This presentation (the “Presentation”) has been prepared by Infant Bacterial Therapeutics AB (publ) (the “Company”) and is furnished to you solely for your information and may not be reproduced or redistributed, in whole or in part, to any other person. By attending the meeting where the
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Slide 4: Infant Bacterial Therapeutics Overview
Infant Bacterial Therapeutics Overview History Current Future n Pharmaceutical microbiome n Main drug candidate IBP-9414 in n Phase II results for IBP-9414 company focused on areas of Phase II finalized recruitment of all expected during the autumn 2017 unmet medical need 120 patients January 2017 n
Slide 5: The IBT concept
The IBT concept n IBT focuses on concepts of altering the human microbiome to prevent or treat diseases n Microbiome of the newborn infant is more dynamic than that of the mature human n Utilize co-evolved human bacterial strains derived from human breast milk Not from etc. n Clinical proof-of-conce
Slide 6: Key IBT people and collaborators
Key IBT people and collaborators Extensive experience and collaboration with tier 1 institutions Key IBT decision makers IBT’s extensive collaboration network n Group President and founder of BioGaia B Ulm Peter Rothschild, MBA Amsterdam USAethleh Germany n Managing Director of BioGaia for 19 years
Slide 7: Financial
Financial n IBT B listed on Nasdaq First North Premier Major Shareholders as of June 30, 2017 n Cash June 2017 ca SEK76m n Annwall & Rothschild Investments AB n Strong investor base and over 5,000 n The Fourth Swedish National Pension Fund (AP4) Shareholders n AMF Aktiefond Småbolag n Application to
Slide 8: 1. IBP-9414 for the prevention of necrotizing enterocolitis
1. IBP-9414 for the prevention of necrotizing enterocolitis
Slide 9: Necrotizing Enterocolitis (NEC)
Necrotizing Enterocolitis (NEC) NEC is severe inflammation of the bowel Survivors have long-term consequences: in preterm infant bowel which can short-bowel syndrome, abnormal growth, lead to death of the baby cognitive, visual and hearing impairments Major surgery required in 20-40% of NEC There is
Slide 10: Necrotizing Enterocolitis
Necrotizing Enterocolitis A devastating gastrointestinal emergency NEC kills 1500 US och 3700 EU infants every year Pictures from Centers for Disease Control and Prevention, National Center on Birth Defects and Developmental Disabilities 10
Slide 11: Who gets NEC?
Who gets NEC? Premature infants Infants birth NEC incidence NEC mortality Mortality (% of weight rate (%) rate (%) weight cohort) 501-750g 12.0% 42.0% 5.0% High incidence 751-1,000g 9.2% 29.4% 2.7% and mortality 1,001-1250g 5.7% 21.3% 1.2% 1,251-1,500g 3.3% 15.9% 0.5% 1,501-2,500g 0.4% 8.2-17% 0.03-
Slide 12: Target population
Target population A preventive therapy for all preterm infants at risk of NEC Current clinical NEC progression Target label population 100 premature infants (751-1,000g) Based on the expected IBP-9414 drug label, the targeted annual label population is: 9 medical NEC cases n US: 56,000 premature inf
Slide 13: What causes NEC?
What causes NEC? Healthy development of gut microbiota + Dysbiosis + Impaired gut motility + Unregulated inflammation ⇒ NEC Our objective is to prophylactically treat against NEC 13
Slide 14: What causes NEC? – Dysbiosis in the gut
Art What causes NEC? – Dysbiosis in the gut Dysbiosis with inappropriate colonization and pathogen blooms in the microbiota can contribute to necrotizing enterocolitis in preterm infants A Cases Controls 100 Gammaproteobacteria Bacilli Clostridia 90 Negativicutes 80 70 Proportion of reads (%) 60 50
Slide 15: What does L. reuteri do to dysbiosis?
What does L. reuteri do to dysbiosis? Fights pathogen growth in gut Pathogen Lactobacillus reuteri Reuterin Source: Talarico 1988, Axelsson 1989 Morita 2008, Spinler 2008, Schaefer 2010, Savino 2015 15
Slide 16: What causes NEC? – impaired gut motility
What causes NEC? – impaired gut motility The baby’s gut movements stop Healthy gut motility Movement Movement NEC Impaired gut motility Standstill 16
Slide 17: What does L. reuteri do to gut motility?
What does L. reuteri do to gut motility? L. reuteri improves gut motility Addition of L. reuteri Source: Wu 2013 17
Slide 18: What causes NEC? – Inflammation in the gut
What causes NEC? – Inflammation in the gut 18
Slide 19: What causes NEC? – Inflammation in the gut
What causes NEC? – Inflammation in the gut Toll-like receptors IEC Teff Teff cells Treg Treg DC cells FoxP 3 Mphage Inflammatory cytokines Teff Teff Treg FoxP3 Teff Teff Anti- Teff inflammatory cytokines 19
Slide 20: What does L. reuteri do to inflammation in the gut?
What does L. reuteri do to inflammation in the gut? Toll-like receptors IEC Teff Teff cells Treg Treg DC cells FoxP 3 Mphage Inflammatory Treg cytokines Teff FoxP3 Treg Treg FoxP3 Anti- FoxP3 inflammatory cytokines Source: Liu 2010, Liu 2012, Liu 2014 20
Slide 21: Clear clinical signal from L. reuteri
Clear clinical signal from L. reuteri All studies show clinically significant reduction of NEC Study Number of patients Reduction in NEC incidence n 40% in the total study population Rojas et al. (2012) n 750 patients n 37% in infants ≤1,500g n 20% in the total study population Oncel et al. (2014) n
Slide 22: IBP-9414 – development plan
IBP-9414 – development plan A development program consisting of two clinical trials Drug development plan 2016 2017 2018 2019 Safety and tolerability trial n A randomized, double blind, parallel-group, dose escalation placebo-controlled multicenter study to investigate the safety and tolerability of
Slide 23: IBP-9414 – Intellectual Property
IBP-9414 – Intellectual Property Three layers of protection MA* IP and Patent Intellectual property EU and US 2013 2016 2020 2030 2035 EU Granted Patent Patent Protection SPC 5y + .5y pedia US Granted Patent PTE 3y + 0,5y pedia Bill A2041?? Worldwide Patent Pending Application Orphan Drug EU Orphan
Slide 24: IBP-9414 Target Product Profile
IBP-9414 Target Product Profile For the prevention of necrotizing enterocolitis n Pharmaceutical therapy approved as Orphan Drug in EU and US to prevent NEC Product description n The first FDA and EMA-approved drug product to prevent NEC n Premature infants ≤1,500g (US) ca 56,000 Patient population
Slide 25: Market potential for IBP-9414 assessment
Market potential for IBP-9414 assessment IBT has mandated consultants to assess the market opportunity… n Including 60 Neonatology Key Opinion Leaders interviews …who have interviewed the relevant key n 15 Pharmacy and Therapeutics neonatologists and pharmacists stakeholders across US (P&T members)
Slide 26: Neonatologists show high willingness to prescribe IBP-9414
Neonatologists show high willingness to prescribe IBP-9414 Clearview US market research indicates an overall 78% physician preference share reflecting a high unmet medical need <1,000 g Infants 1,000 – 1,500 g Infants Physician Preference Share Physician Preference Share ~40% ~90% ~70% (%) ~60% (%)
Slide 27: Treatment up to 34 weeks
Treatment up to 34 weeks 1000 – 1,500 g ~3.4 Infants Weeks <1,000 g ~7.8 Infants Weeks 22 23 24 25 26 27 28 29 30 31 32 33 34 35 Gestational Age (Weeks) Physicians expected to halt IBP-9414 treatment once infants had reached 32 to 34 weeks postmenstrual age 27
Slide 28: Expected Formulary Inclusion by Institution Type
Expected Formulary Inclusion by Institution Type Small Community Institution Type Major Medical Centers Medium Hospitals Hospitals Share of Premature ~60% ~30% ~10% Infants Estimated Formulary ~85% ~60% ~0% Adoption Overall Formulary Approximately 70% of addressable patients are anticipated to recei
Slide 29: Significant market potential for IBP-9414
Significant market potential for IBP-9414 IBT has mandated consultants to assess the market opportunity… n KOLs recognized NEC as a high unmet need with high mortality rates and lack of any medical preventive treatment n NEC Economic Burden is estimated to be 20% of the total cost of …who have stron
Slide 30: 2. IBP-1016 for the treatment of Gastroschisis
2. IBP-1016 for the treatment of Gastroschisis
Slide 31: Gastroschisis
Gastroschisis What is Gastroschisis? Why IBP-1016 for gastroschisis? n Birth defect of the abdominal wall, where the baby’s intestines stick outside of the baby’s body, through a hole beside the belly button ü Dysbiosis and growth of pathogenic bacteria in the gut n Affects late preterm infants with
Slide 32: Clear signal on improved gut motility
Clear signal on improved gut motility 5 studies with L. reuteri Study Number of patients Results Indrio et al. Improved (2008) n 30 patients n 85% increase in gastric emptying rate (p<0.001) gut motility in term and preterm infants Indrio et al. n 34 infants n 39% increase in gastric emptying rate (
Slide 33: Summary
Infant Bacterial Therapeutics Summary n Pharmaceutical microbiome company focused on areas of unmet medical need n Experienced team supported by a well established network of Key Opinion Leaders n Clear clinical signal and safety profile of Lactobacillus Reuteri n Strong Intellectual Property protec
Slide 34: Thank you!
Thank you! Visit us in Stockholm, Sweden Infant Bacterial Therapeutics AB Bryggargatan 10 www.ibtherapeutics.com ☏: +46 (0) 8 410 145 55 info@ibtherapeutics.com 34
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