Irlab Therapeutics Ab Class A · OMXSTO:IRLAB_A
Irlab Therapeutics Ab Class A — Pareto Securities' 11th Annual Healthcare Conference, September 2020
24 slides from Irlab Therapeutics Ab Class A's conference presentation, September 2020
Slide 1: IRLAB Therapeutics
IRLAB Therapeutics Pareto Securities’ 11th Annual Healthcare Conference, September 2020
Slide 2: Disclaimer
Disclaimer This document, “IRLAB Therapeutics” (the “Presentation”), has been prepared by IRLAB Therapeutics AB (publ) (“IRLAB”) and is provided for informational purposes only. All information in this Presentation has been compiled in good faith by IRLAB. Neither IRLAB nor any of its directors, emp
Slide 3: In short
In short Swedish biotech working for a better future for “The dopamine independent symptoms patients affected by Parkinson’s disease e.g., balance, falls, and dementia, … is § Developing novel treatment in Parkinson’s disease very challenging as they don’t answer on the treatment available today.” §
Slide 4: Top priorities for management of Parkinson's
Introduction to IRLAB Top priorities for management of Parkinson’s Parkinson’s is one of the fastest growing disorders Identified top priorities include treatments for: 2040 § Impaired balance and falls 12,9 § Cognitive decline million § Motor complications: levodopa induced diagnosed dyskinesias (L
Slide 5: Pipeline generated by proprietary technology platform: ISP
Introduction to IRLAB Pipeline generated by proprietary technology platform: ISP The Integrative Screening Process (ISP) § Advanced systems biology strategy § Extensive, world unique, standardized database on CNS compounds and classes collected over 25 years § ISP database – Describes CNS drug prope
Slide 6: Portfolio transforming treatment of patients with Parkinson's disease
Introduction to IRLAB Portfolio transforming treatment of patients with Parkinson’s disease Clinical phase II § Mesdopetam (IRL790): To treat debilitating involuntary movements occurring upon long-term treatment with levodopa (PD-LIDs) § Pirepemat (IRL752): To improve reactive postural dysfunction a
Slide 7: The NCE mesdopetam (IRL790)
Mesdopetam The NCE mesdopetam (IRL790) NCE in new CNS compound class WHO-INN proposes new INN, Mesdopetam Globally issued patent, patent life up to 2037 Dose range defined & highly predictable PK properties Safe and well tolerated in Phase I and in PD patient Phase Ib and Phase IIa studies Solid tra
Slide 8: Levodopa-induced dyskinesia (PD-LIDs)
Mesdopetam Levodopa-induced dyskinesia (PD-LIDs) PD-LIDs § PD-LIDs refers to involuntary movements that may occur from long-term use of anti-PD drugs and remains an unmet clinical need since the introduction of levodopa in the 1970s § The reason why LIDs develop is not fully understood, however, it
Slide 9: Objective to increase Good ON
Mesdopetam Objective to increase Good ON Increase daily Good ON through targeted reduction of daily Bad ON (ON with dyskinesia) Levodopa-treated Levodopa + mesdopetam LIDs patient treated LIDs patient Illustration of patients’ motor function during a 24-hour cycle 9
Slide 10: Mechanism of action
Mesdopetam Mechanism of action Reducing dyskinesia by targeting dopamine D3 receptors References: 1. Bordet, R. et al., (1997) Proc Natl Acad Sci U S A 94(7): 3363-3367; 2. Marcellino, et al., (2008) J Biol Chem 283(38): 26016-26025; 3. Bezard, et al., 10 (2003) Nat Med 9(6): 762-767; 4. Payer,et al
Slide 11: Clinical Phase IIa dose response analyses: Good ON-time vs dose
Mesdopetam Clinical Phase IIa dose response analyses: Good ON-time vs dose Supportive analysis of Phase IIa data § Support for dose dependent efficacy § Peak benefit appears at 7.5 mg b.i.d. § No added benefit above 7.5 b.i.d. § Relevant dose range identified LS mean; adjusted change from baseline;
Slide 12: Clinical Phase IIa: Key conclusions
Mesdopetam Clinical Phase IIa: Key conclusions Phase IIa in PD § Clinically meaningful & quantitatively impressive effects on dyskinesias assessed by Hauser diaries and by UPDRS dyskinesia assessments § Patients reported functional improvements § Qualitative shift in ON-time towards more daily ”Good
Slide 13: First-in-class to increase daily "Good ON-time"
Mesdopetam First-in-class to increase daily “Good ON-time” Overview of the clinical studies Completed Planned Phase Ib Phase IIa Phase IIb/III Pivotal studies PD-LIDs PD-LIDs PD-LIDs PD-LIDs Phase I SAD +MAD Phase II PD-Psychosis § Well tolerated § Well tolerated § Clinically meaningful & § Next stu
Slide 14: Why mesdopetam?
Mesdopetam Why mesdopetam? § Mechanism – D3 receptor central for manifestation of LIDs and; – D3 receptor central for development of LIDs § Efficacy (Phase Ib & IIa studies) highly clinically relevant (at least 50% up vs. competition) § Outstanding side effect profile vs competition § No competition
Slide 15: Falls in Parkinson's disease is a major issue
Pirepemat (IRL752) Falls in Parkinson’s disease is a major issue § To reduce falling is the greatest medical need in Parkinson's disease § Reasons why people with Parkinson's fall1,2: Cognitive decline Impaired balance Falls § “An intervention that demonstrates a 25% relative reduction in falls rate
Slide 16: The NCE pirepemat
Pirepemat (IRL752) The NCE pirepemat NCE, new mode of action candidate Patent issued in all major markets, ultimate case exclusivity > 2040 WHO-INN recommends new INN, pirepemat Well tolerated in healthy volunteers and in Parkinson’s disease patients IRL752 shows promising improvements in postural s
Slide 17: Postural dysfunction or falls in Parkinson's disease
Pirepemat (IRL752) Postural dysfunction or falls in Parkinson’s disease What is falls in Parkinson’s? § Postural dysfunction is strongly linked to cognitive decline § Associated with increased risk of falls and corresponding complications such as fractures § Approximately 60% of Parkinson’s patients
Slide 18: Mechanism of action
Pirepemat (IRL752) Mechanism of action Pirepemat is intended to be used as an adjunct treatment in Parkinson’s to improve postural dysfunction and reduce falls Improves balance & reduce risk of falls through regio-specific increases of NA & DA in frontal cortex References: 1. Huang C et al., Neuroim
Slide 19: Clinical Phase IIa data: Improvement of Postural dysfunction and Falls
Pirepemat (IRL752) Clinical Phase IIa data: Improvement of Postural dysfunction and Falls Balance Falls Change from baseline (%) in sum score of UPDRS Absolute change with 95% conf. intervals for UPDRS q13 items 13, 14 and 30 (Falling unrelated to freezing) in fallers IRL752 Placebo 0 -5 -10 1. Rare
Slide 20: Clinical Phase I and IIa: Key conclusions
Pirepemat (IRL752) Clinical Phase I and IIa: Key conclusions § Well tolerated in young healthy volunteers and in PD patients § IRL752 shows promising improvement potential in PD: – Postural stability / Balance – Reduced fall frequency – Apathy – Cognitive impairment § Effects suggest cortical mode o
Slide 21: First-in-class to treat Postural dysfunction/Falls
Pirepemat (IRL752) First-in-class to treat Postural dysfunction/Falls Overview of the clinical development Completed Planned Ph I: SAD+MAD Phase I Ph IIaIIa Phase Ph IIb Phase IIb Pivotal studies (healthy volounteers) SAD+MAD (patients) PD-Dementia (patients) PD-Falls § Next study: A Phase IIb to ev
Slide 22: Why pirepemat?
Pirepemat (IRL752) Why pirepemat? § Mechanism – Pirepemat acts by antagonism at 5HT7 and alpha 2 receptors leading to frontal cortical increase of NA and DA improving cognitive function and reactive postural responses (i.e. balance) – Frontal cortical increase of NA and DA central for reactive postu
Slide 23: Focus during 2020
Focus during 2020 Key milestones 2020 ü WHO-INN recommends mesdopetam for IRL790 ü WHO-INN recommends pirepemat for IRL752 Positioning of the mesdopetam and ü Financing round of ca 215 MSEK pirepemat programs Move to Nasdaq Stockholm Main Market § First-in-class drug candidates § Novel mechanisms of
Slide 24: Q&A
Q&A Contact: Nicholas Waters, CEO, nicholas.waters@irlab.se IRLAB is a Swedish research and development company focused on developing novel treatments for Parkinson's disease. The company's two lead drug candidates, mesdopetam (IRL790) and pirepemat (IRL752), which both have cleared Phase IIa- studi
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