Infant Bacterial Therapeutics Ab Class B · OMXSTO:IBT_B
Infant Bacterial Therapeutics Ab Class B — Nordea presentation (November 2019)
37 slides from Infant Bacterial Therapeutics Ab Class B's conference presentation, Nov 26, 2019
Slide 1: Infant Bacterial Therapeutics
Infant Bacterial Therapeutics Staffan Strömberg November 26, 2019
Slide 2: Disclaimer
Disclaimer You must read the following before continuing. The following applies to this document and the information provided in this presentation by Infant Bacterial Therapeutics AB (publ) (the “Company”) or any person on behalf of the Company and any other material distributed or statements made i
Slide 3: Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB Founded in 2013 in Stockholm, Sweden IPO in 2016, listed on Nasdaq Stockholm - Market cap SEK 1 700 M ($175 M) - Cash position as of September 30, 2019 SEK 511 M ($53 M) sufficient to fund IBP-9414 development to market Pivotal Phase III Trial for lead development pr
Slide 4: The IBT concept
The IBT concept - Establish the human microbiome to treat diseases related to poor gut function - Newborn infant microbiome is dynamic - Human bacterial strains derived from human breast milk - Published clinical proof-of-concept signal 4
Slide 5: High unmet medical need
High unmet medical need
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Slide 7: Breakthroughs in preterm infant care
Breakthroughs in preterm infant care Incubator use Parenteral Mortality nutrition Surfactant prophylaxis IBP-9414 Focus on breastfeeding Improved gut function CDC/NCHS, National Vital Statistics System 7
Slide 8: Causes of death
Proportion of All Deaths in Each Age Group (%) Causes of death nan 1005 Unknown 90-4 @ Other Congenital anomalies 80-4 . CNS injury ® Infection 70-5 @ Bronchopulmonary dysplasia 60- @ Necroti izing enterocolitis 50+ @ Respiratory distress syndrome 40- @ Immaturity 30-5 20+ 10- 0-4 Birth to >12 to >7
Slide 9: Feeding the preterm infant
Feeding the preterm infant Establishing enteral (mouth) feeding in preterm infants is a primary clinical goal to attain normal growth, important for e.g. cognitive development. Prolonged parenteral (needle feeding) nutrition increases cost and causes complications including: cholestasis, increased r
Slide 10: Economics of NICU stay
Economics of NICU stay Overall cost of of preterm births in the US is estimated at $26 Billion More than 65% of NICU admissions have an average LOS of about 20 days Average NICU cost per day is $3,000 Cost of average NICU admission is similar to that of patients admitted for spinal cord injury and h
Slide 11: Necrotizing enterocolitis (NEC)
Necrotizing enterocolitis (NEC) - NEC is severe inflammation of the bowel in preterm infants where 20-40% need complicated and costly surgery - Survivors have long-term consequences such as short-bowel syndrome, abnormal growth, cognitive, visual and hearing impairments - There is no therapy availab
Slide 12: NEC – a devastating disease
NEC – a devastating disease The smaller the premature infant is at birth, the more likely he/she will die NEC incidence rate NEC mortality rate 501-750g 42.0% 751-1,000g 29.4% 1,001-1250g 21.3% 1,251-1,500g 15.9% 1,501-2,500g 12,7% Source: Shelley 2012, Bolisetty 2000, Llanos 2002, Fitzgibbons 2009,
Slide 13: Economic burden of NEC
Economic burden of NEC Costs continue after NICU discharge Average total treatment cost of NEC is Accumulated USD cost between 6-36 USD 500,000 per patient in the USA months. NEC Economic Burden is estimated to be 20% of the total cost of initial care and USD 5 Billion spent annually on NEC in the U
Slide 14: The product
The product
Slide 15: Pharmaceutical drug candidate IBP-9414
Pharmaceutical drug candidate IBP-9414 ◆ Rigorous pharmaceutical Chemistry- Manufacturing-Control standards in all steps with GMP according to 21 CFR Part 210 ◆ Developed under IND ◆ Single dose vial with dose accuracy following ICH Guidelines for Pharmaceuticals ◆ Stringent control of bioburden and
Slide 16: Lactobacillus reuteri
Lactobacillus reuteri Active substance of IBP-9414 Lactobacillus reuteri present Lactobacillus reuteri (orange) on women’s breasts adhering to intestinal mucus 16
Slide 17: L. reuteri - mechanisms of action
L. reuteri - mechanisms of action Combats dysbiosis Reduces inflammation Improves gut motility Improved gut function including prevention of NEC Schaefer 2010, Walter 2011, Wu 2013 17
Slide 18: Clinical Signal - Dysbiosis
Clinical Signal - Dysbiosis Dysbiosis with pathogen blooms in the microbiota can contribute to necrotizing enterocolitis in preterm infants NEC Controls Days after birth Bloom of pathogen-rich gamma Microbiome optimization may provide proteobacteria prior to onset of NEC a novel strategy for prevent
Slide 19: Combats dysbiosis
Combats dysbiosis L. reuteri produces species-specific antimicrobial substance called Bacteria reuterin ▪ Bacillus subtilis ▪ Escherichia coli (patogena) ▪ Listeria monocytogenes ▪ Salmonella typhimurium ▪ Campylobacter jejuni ▪ Enterobacter sakazakii ▪ Porphyromonas gingivalis ▪ Shigella spp ▪ Clos
Slide 20: Clinical data - Combats dysbiosis
Clinical data - Combats dysbiosis Infant fecal pathogens after 1 month L. reuteri treatment * Number of positive feces samples for identified pathogens from 30 infants * P≤0.05 * L. reuteri decreased gut pathogen colonization in infants Source Savino 2015 20
Slide 21: Clinical - Anti-inflammatory
Clinical - Anti-inflammatory Treg cells increase in infant blood after L. reuteri administration Treg * P≤0.05 FoxP3 * FOXP3 mRNA levels Placebo L. reuteri L. reuteri recruitment of Treg cells now shown in infants Source Savino 2017 21
Slide 22: Clinical data - Modulation of gut motility
Clinical data - Modulation of gut motility Fasting antral area Regurgitation * * P≤0.05 * No. of episodes of regurgitation Formula Formula Gastric emptying Stooling + L. reuteri + placebo * * No. of episodes of evacuations Formula Formula + L. reuteri + placebo Preterm infants given L. reuteri show
Slide 23: L. reuteri protects from NEC in animal models
L. reuteri protects from NEC in animal models Control Control NEC NEC NEC NEC NEC+Lr NEC+Lr NEC+Lr NEC + L. reuteri Improved survival from NEC Reduced intestinal damage Liu, 2012, 2013, 2014 23
Slide 24: Clinical signal
Clinical signal
Slide 25: Publications with clinical signal of NEC reduction
Publications with clinical signal of NEC reduction 25
Slide 26: NEC clinical signals
NEC clinical signals Meta-analysis of 1166 patients <1500g all randomized controlled trials gives an Odds Ratio of 0.51 26
Slide 27: Feeding Tolerance - clinical signals and consequences
Feeding Tolerance - clinical signals and consequences Time to full enteral feeding -1.28 days [-1.85, -0.72] Feeding intolerance events OR 0.51 [0.35, 0.75] Days on Parenteral Nutrition -1.67 days [-2.94, -0.41] Days in hospital -5.25 days [-8.46, -2.05] 27
Slide 28: Clinical Development Program
Clinical Development Program
Slide 29: IBP-9414 Phase II: Safety & Tolerability Study
IBP-9414 Phase II: Safety & Tolerability Study RCT; 120 infants 500g - 2000g; 14 days daily dosing from 48h; dose 108 or 109 CFU or placebo; follow up 1 & 6 months Dr. Neu, Gainesville FL, PI Dr. Ashley, Durham NC Dr. Bloom, Wichita KS Dr. Del Moral, Miami FL Dr. Garg, Los Angeles CA Dr. Gerstmann,
Slide 30: IBP-9414 Phase II Safety & Tolerability Study
IBP-9414 Phase II Safety & Tolerability Study • Similar AE and SAE profile in active and placebo groups • No SAE related to study drug • No evidence of cross-contamination with IBP-9414 in placebo treated infants • Executed according to timeplan Key conclusion: Safe and well-tolerated http://ibthera
Slide 31: Endorsed Phase III Pivotal Trial
Endorsed Phase III Pivotal Trial - IBT has developed the IBP-9414 program in cooperation with the regulators and with considerations of KOLs experience and clinical practice - CTX/IND approval received in UK, Spain, Hungary, France and USA, application filed in Israel 31
Slide 32: IBP-9414 Clinical Development Plan
IBP-9414 Clinical Development Plan Phase 2 Phase 3 Safety and Tolerability Trial Efficacy and Safety Trial – Connection Study ◆ Randomized, double blind, ◆ Randomized, double blind, dose escalation, placebo-controlled placebo-controlled ◆ Multicenter study ◆ Multicenter study ◆ Safety and tolerabili
Slide 33: Strong interest from the market
STRONG INTEREST FROM THE MARKET
Slide 34: A valuable pharmaceutical
A valuable pharmaceutical 34
Slide 35: A global need
A global need 15 Million Pre-term births annually 56 000 label © 108 000 label population = 360 population MUSD annual sales for NEC prevention 408 000 label population =O
Slide 36: IBP-9414 our lead Phase III program
IBP-9414 our lead Phase III program Ticks all relevant pillars for the development of a successful drug Medical need ✔ Mechanism of action ✔ Clinical data ✔ Safe ✔ Aligned regulatory agencies ✔ GMP manufacture ✔ Market exclusivity ✔ Aligned payers ✔ Orphan Drug and Rare Pediatric Disease designation
Slide 37: Thank you
Thank you INFANT BACTERIAL THERAPEUTICS
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