Infant Bacterial Therapeutics Ab Class B · OMXSTO:IBT_B
Infant Bacterial Therapeutics Ab Class B — Investor Presentation (January 2017)
26 slides from Infant Bacterial Therapeutics Ab Class B's investor presentation, January 2017
Slide 1: Infant Bacterial Therapeutics Corporate presentation
Infant Bacterial Therapeutics Corporate presentation January 2017
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: IBT corporate overview
IBT corporate overview Pharmaceutical microbiome company focused on areas of unmet medical need Founded by Staffan Strömberg and Eamonn Connolly in 2013 as a subsidiary of BioGaia and headquartered in Stockholm, Sweden Our company currently runs 2 development programs: • IBP-9414 for the preve
Slide 5: 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 In 2016 became Chairman of IBT Bethlehem Ulm Peter Rothschild, MBA Amsterdam Germany USA Group President and founder of BioGaia Netherlan
Slide 6: The IBT concept
The IBT concept IBT focuses on concepts of altering the human microbiome to prevent or treat diseases Microbiome of the newborn infant is more dynamic than that of the mature human Utilize co-evolved human bacterial strains derived from human breast milk Clinical proof-of-concept signal publ
Slide 7: Drug candidate selection
Drug candidate selection Derived from a lactating Latin American lady L. reuteri mechanisms of action 1 Anti-pathogen effects 2 Modulation of gut motility 3 Anti-inflammatory effects IBT is developing two programs, which contain L.reuteri as active substance Stage Indication PC Ph.I Ph.II Ph.III NEC
Slide 8: Neonatal and pediatric settings require safety
Neonatal and pediatric settings require safety IBT uses safe and well established strain combined with rigorous CMC approach Established safety profile – published clinical literature Formulation and CMC approach Use of L. reuteri in over 1,300 adults: Recent incident in NICU, where a • Safe and
Slide 9: 1. IBP-9414 for the prevention of Necrotizing enterocolitis
1. IBP-9414 for the prevention of Necrotizing enterocolitis ‹› 9
Slide 10: Necrotizing Enterocolitis
Necrotizing Enterocolitis What is NEC? What happens when you have NEC? Severe and unpredictable gastrointestinal Condition remains untreatable condition affecting preterm infants Major surgery will be required for 20-40% of NEC causes necrosis in the intestinal tract and patients with NEC de
Slide 11: NEC incidence and mortality
NEC incidence and mortality Incidence / mortality by weight Infants NEC incidence rate Mortality NEC mortality rate (%) birth weight (%) (% of weight cohort) 501-750g 12.0% 42.0% 5.0% High 751-1,000g 9.2% 29.4% 2.7% incidence 1,001-1,250g 5.7% 21.3% 1.2% and mortality 1,251-1,500g 3.3% 15.9% 0.5% 1,
Slide 12: Target population
Target population 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 US: 56,000 premature infants Treated by EU5: 105,000 premature infants antibiotics
Slide 13: Preventing NEC though the microbiota using L. reuteri
Preventing NEC though the microbiota using L. reuteri Major processes involved in NEC L. reuteri mechanisms of action for NEC 1 Dysbiosis and growth of Inhibits a wide range of 9 pathogenic bacteria in the gut of the preterm Anti-pathogen effects bacteria and fungi in vitro and in infants 2 Modulate
Slide 14: Clear clinical signal
Clear clinical signal All studies show clinically significant reduction of NEC Study Number of patients Results 750 patients (372 L. 40% reduction in NEC incidence in the total study Randomised Rojas et al. (2012) reuteri and 378 population double-blind placebo) 37% reduction in NEC incidence
Slide 15: KOL interactions and regulatory status
KOL interactions and regulatory status Key Opinion Leaders and regulatory interactions… …resulting in a development plan 1 Key Opinion Leaders workshops FDA and EMA agree that pre-clinical data is enough to support Phase II, Phase III and drug IBT has had 8 KOL workshops across the US, registrat
Slide 16: 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 A randomized, double blind, parallel-group, dose escalation placebo-controlled multicenter study to investigate the safety and tolerability of
Slide 17: Current available treatments and standard of care
Current available treatments and standard of care IBP-9414 is designed to re-define current best practice with evidence-based drug Current best practice approach Human breast milk Preventative approaches Slow feed advancement / early initiation of feeds Limited use of probiotics IV fluids Me
Slide 18: IBP-9414 Target Product Profile
IBP-9414 Target Product Profile For the prevention of necrotizing enterocolitis Pharmaceutical therapy approved as an Orphan Drug in the EU and US to prevent Product description NEC The first FDA and EMA-approved drug product to prevent NEC Premature infants ≤1,500g (US) Patient population P
Slide 19: Significant potential for IBP-9414 identified in the market
Significant potential for IBP-9414 identified in the market IBT has mandated consultants to assess the market opportunity… …who have interviewed Including 60 Neonatology Key Opinion Leaders interviews the relevant key 15 Pharmacy and Therapeutics neonatologists and pharmacists (P&T members) stak
Slide 20: 2. IBP-1016 for the treatment of Gastroschisis
2. IBP-1016 for the treatment of Gastroschisis
Slide 21: Gastroschisis
Gastroschisis What is Gastroschisis? What causes gastroschisis? 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 9 Dysbiosis and growth of pathogenic bacteria in the gut Affects late preterm infants with an a
Slide 22: Gastroschisis
Gastroschisis Healthy babies Babies with gastroschisis 1-5 months (or more in severe cases), with Days in hospital Less than 3 nights heavy cost implications for NICU care and bed occupancy Parenteral nutrition for 1-5 months Breast or formula- Nutrition Severely impaired gastrointestinal
Slide 23: Treating gastroschisis with IBP-1016
Treating gastroschisis with IBP-1016 Major processes involved L. reuteri mechanisms of action for gastroschisis 1 Inhibits a wide range of 9 Dysbiosis and growth of pathogenic bacteria in the gut Anti-pathogen effects bacteria and fungi in vitro and in infants 2 Improves gut peristalsis 9 Sub-optima
Slide 24: Clear signal on improved gut motility
Clear signal on improved gut motility 5 studies Study Number of patients Results Indrio et al. (2008) 30 patients (10 on L. reuteri, 89% increase in gastric emptying rate with L. reuteri Improved 10 on placebo and 10 (p<0.001) gut motility breast-fed controls) in term and preterm infants 34 in
Slide 25: Conclusion
Conclusion IBT is committed to altering the human microbiome to prevent or treat diseases with high unmet need Currently focussed on diseases of the neonate given the naïve and dynamic nature of the infant microbiome Key technology platform based on L.reuteri with multiple well evidenced mecha
Slide 26: Contact us
Contact us 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 ‹› 26
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