Invex Therapeutics Ltd. · ASX:IXC
Invex Therapeutics — Corporate Update (March 2020)
23 slides from Invex Therapeutics's corporate update, March 2020
Slide 1: Invex Therapeutics
Invex Therapeutics Repurposing an approved drug Business update March 2020 ASX Code: IXC
Slide 2: Disclaimer
Disclaimer This presentation (Presentation) is issued by Invex Therapeutics Ltd (ASX:IXC) (the Company or IXC). The information presented in this Presentation may contain predictions, estimates and other forward-looking statements. Although the company believes that its expectations are based on rea
Slide 3: Invex overview
Invex overview • Listed on ASX in July 2019 • Specialise in neurological conditions characterised by raised intracranial pressure • Initial focus on treating idiopathic intracranial hypertension (IIH) • IIH is a rapidly growing orphan indication • Orphan Drug Designation granted in the US and Europe
Slide 4: Company snapshot
Company snapshot Company Major Shareholders Repurposed Proven Drug Presendin™ (Exenatide) Directors / Management 20% Clinical Stage Phase II Minderoo Pty Ltd 9.1% JK Nominees Pty Ltd 7.3% Orphan Disease Focus IIH^ + Other Tisia Nominees Pty Ltd 7.2% Orphan Designation Granted USA + EU Oaktone Nomine
Slide 5: What is Idiopathic Intracranial Hypertension (IIH)?
What is Idiopathic Intracranial Hypertension (IIH)? Patient typically presents at A&E or to an optometrist with a combination of debilitating daily headaches and severe vision 70-90% severe, daily headaches3 impairment Definitive diagnostic signal is raised intracranial hypertension / 25% permanent
Slide 6: Diagnosing Idiopathic Intracranial Hypertension
Diagnosing Idiopathic Intracranial Hypertension1 2 – Brain Patient 1 – Papilloedema 4 – Cerebrospinal imaging within 3 – Lumbar puncture examination Fluid (CSF) testing ~90% female 24 hours ~10% male Needle is inserted into the To identify swollen/damage to Normal fluid content and spinal column to
Slide 7: Growing incidence of IIH
Growing incidence of IIH ▪ IIH is a rapidly growing orphan indication driven by changing demographics, incidence CAGR of 5.2% 2002-20161 As the costs of managing a disease rise, the cost-effectiveness of an ▪ 90% of IIH patients are obese women of childbearing age1 intervention such as Presendin™ im
Slide 8: Current treatments for IIH are limited
Current treatments for IIH are limited Idiopathic Intracranial Hypertension – Treatment Guidelines1 Non-Surgical / Device Surgical / Device (Severe cases) Acetazolamide is used ‘off label’ No immediate threat to vision Vision threatened (not regulatory cleared) for IIH, has limited efficacy & poor C
Slide 9: Key clinician pathways in the management of IIH
Key clinician pathways in the management of IIH Optometrists No Immediate Threat to Vision ▪ Often patients with vision issues consult an optometrist, who in turn are primary referrers to ophthalmologists ▪ ~37,000 optometrists in the USA1 Ophthalmologists ▪ ~19,000 ophthalmologists in the USA1 ▪ ~2
Slide 10: Total addressable market (TAM) – expected to grow
Total addressable market (TAM) – expected to grow 39,8061 Annual incidence of IIH in Invex markets 3.4% Estimated growth in incidence per annum 5 (60% - EU, 40% - USA) 55,000 Estimated annual incidence in 2030 >A$2.3bn Implied TAM in 2030 40% remain undiagnosed2 60% diagnosed2 10% emergency surgical
Slide 11: Repurposing Exenatide
Repurposing Exenatide ▪ Exenatide was approved in 2005 in the US & 2006 in the EU for the treatment of Type II diabetes ▪ In its Byetta® form Exenatide is administered as a twice-daily, sub-cutaneous injection or as Bydureon®, as a once weekly injection ▪ Exenatide is a well tolerated drug and consi
Slide 12: Exenatide reformulation strategy
Exenatide reformulation strategy Current dose not optimal to treat Exenatide @ current IIH diabetic dose1 tested Current formulations have either Risk for off label use of in Phase II to insufficient half life2 or too slow Invex is developing a Byetta® or Bydureon ® is demonstrate proof of onset3 &
Slide 13: Reformulation – Clinical and regulatory requirements
Reformulation – Clinical and regulatory requirements ▪ Ex-AstraZeneca’s Exenatide formulation team engaged to help work on Presendin™ repurposing ▪ Pharmacokinetic (PK) evidence obtained in mouse models has shown that Invex’s novel 24 hour proprietary formulation of Exenatide (i.e. Presendin™) provi
Slide 14: Benefits of orphan drug designation
Benefits of orphan drug designation Designation granted for treating rare diseases: <200k patients in Orphan Drug Designation granted in 2017 by EMA (EU) & USA, < 5/10,000 in the EU1 FDA (USA) Invex anticipates a Phase III study v placebo will meet regulatory Single pivotal Phase III registration st
Slide 15: Phase II trial design – results due early 2Q 2020
Phase II trial design – results due early 2Q 2020 Randomised double blinded placebo controlled clinical study 1 • n=16 • Female, 18-60 years old 12 • Confirmed Idiopathic weeks Intracranial Hypertension diagnosis Outcome Synopsis 1:1 Confirmation of GLP-1 activity in brain driving ICP reduction Plac
Slide 16: Key personnel for Presendin™ development
Key personnel for Presendin™ development Prof Alexandra Sinclair Executive Director and Chief Scientific Officer ▪ Neurology consultant and clinician scientist ▪ Global leader in the pathophysiology of idiopathic intracranial hypertension and headaches, with over 10 years research in this field ▪ Si
Slide 17: Timeline – key milestones
Timeline – key milestones Initiate second Phase II indication results Finalise Phase III design Phase II study 2Q 3Q 1H 2020 2020 2021 2Q 4Q 1H 2020 2020 2021 Complete animal PK / Results of human PK Initiate Phase III tolerability study Study registration study 17
Slide 18: Repurposed, orphan drug comparable company with Phase II data
Repurposed, orphan drug comparable company with Phase II data ▪ Invex is unique amongst ASX listed peers, with a repurposed, proprietary drug with orphan designation in the USA and EU ▪ Proven mechanism of action and safety with clinical trial endpoints well recognised by regulatory agencies for reg
Slide 19: Indicative Phase III design
Indicative Phase III design1 Randomised double blinded placebo controlled Criteria multi-centre clinical study World class Medical Advisory ▪ >18 years old Board established by Invex to ▪ Sig. raised ICP & confirmed IIH diagnosis by Updated Modified Dandy criteria provide input on trial design as ▪
Slide 20: Summary
Summary ▪ Large, growing market for IIH with no approved (regulatory cleared) or efficacious drug-based interventions ▪ Orphan Drug Designation in the USA and EU provides expedited, cost-effective clinical trial recruitment, reporting and approval/registration as well as commercial exclusivity for u
Slide 21: Contacts
Contacts COMPANY COMPANY INVESTORS Dr Jason Loveridge David McAuliffe Dr Tom Duthy Non-Executive Chairman Non-Executive Director Nemean Group +49 152 23709246 +61 408 994 313 +61 402 493 727 jloveridge@invextherapeutics.com dmcauliffe@invextherapeutics.com tduthy@nemean.com.au 21
Slide 22: Appendix
Appendix 22
Slide 23: Invex scientific data validates approach for IIH
Invex scientific data validates approach for IIH Intracranial pressure % - exenatide vs saline 1 120% 100% ▪ Treatment was given daily for 5 days, and ICP was recorded on days 2, 4, and 6, before and ICP - % of baseline on day 2 after the rats received a subcutaneous (SC) 80% injection of either sal