Incannex Healthcare Inc. · NASDAQ:IXHL
Incannex Healthcare — Technical Presentation (May 2023)
16 slides from Incannex Healthcare's technical presentation, May 3, 2023
Slide 1: IHL-675A Phase 1 clinical trial results
IHL - 675A P h a s e 1 c li n i c a l t r i a l t o a s s e s s s a f e t y an d p h a r m a c o k i n e t i c s a s a p o t e n t i al a n t i - i n f i a m m a t o r y d r u g c and i d a t e A S X T i c k e r : I H L | N A S DA Q T i c k e r : I X H L
Slide 2: Disclosure and Disclaimer
D i s c l o su r e a n d D i s c la i m e r Not an offer of Securities This document has been independently prepared by Incannex Healthcare Limited (Incannex) and is provided for informational purposes only . This document does not constitute or contain an offer, invitation, solicitation or recommen
Slide 3: Results Summary
R e su l t s S u m m a r y T h e 3 6 p a t i e n t c li n i c a l t r i al d e m o n s t r a t e s I H L - 6 7 5 A t o b e w e l l t o l e r a t e d , w i t h n o s e r i o u s a d v e r s e e v e n t s o f c o n c e r n . I H L - 6 7 5 A P h a s e 1 c l i n i c a l t r i al IHL - 675A Results Prese
Slide 4: About Incannex and IHL-675A
IHL - 675A Abo u t I n c a n n e x h a s d e m o n s t r a t e d t h a t I H L - 6 7 5 A c o m p o n e n t s , H C Q a n d C B D a c t s y n e r g i s t i c a ll y t o i n h i b i t p r o d u c t i on of i n fi a m m a t o r y c y to k i n e s a n d r e d uc e d i s e a s e s e v e r i t y i n a n i
Slide 5: Reducing disease severity in animal models
IHL - 675A R e d u c i n g d i s e a s e s e v e r i t y i n a n i m a l m o d e l s IHL - 675A outperformed HCQ and CBD administered alone at reducing infiammatory disease scores — a strong efficacy s i gn a l d e m an d i n g c li n i c a l a s s e s s m e n t. P e r f o r m a n c e R e su l t s I
Slide 6: IHL-675A clinical development and addressable market
– A n i m a l d i s e a s e m o d e l r e s u l t s w e r e a m a j o r commercial signal: targeting the disruption of i n cu m b e n t m u l t i - b ill i o n d olla r m a r k e t s f o r d i se a se s of i n f i a m m a t i o n . – T h e a d d r e s s a b l e t a r g e t m a r k e t s e x c ee d $
Slide 7: Phase 1 clinical trial design
Aim T o a s s e s s t h e s a f e t y , t oler a b il i t y a n d p h a rm a c o k i n e t i c s of I H L - 6 7 5 A c o m p a r e d t o r e f e r e n c e listed drugs for CBD and HCQ, marketed as Epidiolex a n d P la q u en i l r e sp e c t i v e l y , i n h ea l t h y v o l u n t eer s . IHL - 675A
Slide 8: Safety/tolerability results
IHL - 675A S a f e t y / t ole r a b il i t y r e s u l t s R e s u l t s – N o a d v e r s e e v e n t s o f c o n c e r n . – Adverse events were consistent with public reports for Epidiolex an d P l a q uen i l . – Treatment - related treatment emergent adverse events (TEAEs) included abdominal p
Slide 9: Pharmacokinetics: CBD
P h a r m a c o k i n e t i c s: CBD R e s u l t s – C o m p a r e d t o E p i d i o l e x , C B D d o s e d i n I H L - 6 7 5 A : – Reached a greater maximum concentration (C max ), 1.57 times higher – Was taken up more rapidly (T max ), 26 % faster – W a s c l ea r e d m o r e q u i c k l y ( T 1
Slide 10: Pharmacokinetics: HCQ
R e s u l t s – Compared to Plaquenil, HCQ from IHL - 675A was: – Taken up more slowly (T max ), 46% slower – Reached a similar maximum concentration (C max ) – Had a similar rate of clearance (T 1/2 ) – Had a similar total exposure (AUC inf ) – These differences are only trends at this point (p>0.0
Slide 11: Conclusions
R e s u l t s Conclusions 01. IHL - 675A is well tolerated in healthy volunteers. 02. Adverse events for IHL - 675A were consistent w i t h w h a t w a s o b s e r v e d , a n d h a s b e e n p u b l i c l y r e po r t e d fo r E p i d i o l e x a n d P la q u e n il . 03. B o t h ac t i v e p h a r
Slide 12: Phase 2 Clinical Trials and Next Steps
Incannex has commenced a phase 2, blinded, placebo controlled clinical trial to determine the safety and effect on pain and function of IHL - 675A in patients with rheumatoid arthritis. The trial is engaging up to 10 trial sites and recruiting 120 patients in total. Planning of Phase 2 studies in pa
Slide 13: Clinical and Regulatory Progression
Clinical and Regulatory Progression P r e - c li n i c al studies F D A p r e - I N D meeting P h a s e 1 c l i n i c a l t r i al P h a s e 2 – I n fi a m m a t o r y B o w e l Diseases P h a s e 2 – Infiammatory L un g C o n d i t i ons P h a s e 2 – R h e u m a t oi d Arthritis P h a s e 3 P h a
Slide 14: CBD metabolite PK results
IHL - 675A Epidiolex C max T max AUC inf T 1/2 C max T max AUC inf T 1/2 (ng/mL) (hr) (hr*ng/mL) (hr) (ng/mL) (hr) (hr*ng/mL) (hr) CBD Mean 207.04 2.13 841.08 220.17 131.89 2.88 725.9 231.22 SD 117.44 0.91 358.63 53.85 61.92 1.21 223.98 56.45 Min 72.6 1.02 391 113.84 45.6 1.5 355 144.41 Max 472 4 16
Slide 15: HCQ metabolite PK results
H C Q a n d m e t ab ol i t e P K r e s u l t s IHL - 675A Epidiolex C max T max AUC inf T 1/2 C max T max AUC inf T 1/2 (ng/mL) (hr) (hr*ng/mL) (hr) (ng/mL) (hr) (hr*ng/mL) (hr) HCQ Mean 54.71 5.59 2986 182.62 55.52 3.46 3430.8 251.6 SD 23.85 2.51 1244.46 93.7 24.81 1.94 1104.38 73.65 Min 22 2 800
Slide 16: Media, Investor and Partnership Enquiries
M e d i a E n q ui r i e s F o r m e d i a r e l a t e d e n q ui r i e s p le a s e c o n t a c t : J o e l L a t h a m joel@incannex.com.au I n v e s t o r E n q ui r i e s F o r i n v e s t o r r e l a t e d e n q ui r i e s p le a s e c o n t a c t : B r a d D i l k e s investors@incannex.com.au
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