- APIRx hastwenty-two (22) active clinical and pre-clinical research and development projects
- therapeutic candidates are targeted at treating pain, dementia, Parkinson's disease, restless leg syndrome, gastrointestinal diseases, periodontitis, addiction disorders, skin conditions and ophthalmic conditions
- therapeutic candidates are underpinned by an extensive intellectual property portfolio that includes 19 granted patents and 23 pending patents
- proposed acquisition price of US$93.3M in all scrip transaction
- the transaction affirms Incannex's position as a global leader in the fields of cannabinoid, psychedelic, and combination pharmaceuticals.
- Dr Anastassov and Mr Changoer are experienced clinical researchers with medical and scientific backgrounds. They will be employed by Incannex on a full-time basis following completion of the acquisition and will continue to drive the development of APIRx projects, whilst also assisting with the development of the Company's existing projects. They are experienced with liaising and negotiating with the U.S. Food and Drug Administration ('FDA'), having undertaken numerous pre- investigational new drug ('IND') meetings, and opening two (2) IND applications for the MedChew RL and the MedChew Dronabinol medicinal product candidates. Furthermore, APIRx has strong relationships with international academic institutions and research hospitals including Mount Sinai School of Medicine, New York (USA), University of St. Andrews (UK), Free University of Amsterdam (NL), University of Wageningen (NL), and Mauritsclinics (NL).
lincial Project
Addressable Market Opportunity ($US)
Stage of Development
Regulatory Stage of
Next Steps
Relevant
1 Development
Patents
2 3 Medchew-1401
4 Pain and Spasticity in
$62 Bn (Global) in '21 (a)
Pre-clinical
Pre-IND completed in NL
Phase 1
Granted
5 Multiple Sclerosis
and Switzerland
6 7 Medchew GB
8 Post-herpatic Neuralgia
$3.7 Bn (U.S.) by '27 (n)
Pre-clinical
FDA Pre-IND
Phase 1
Granted
9 Medchew-1502
10 Parkinson's Disease
$8.05 Bn (Global) by '27; 6.5% CAGR (l)
Pre-clinical
FDA Pre-IND
Phase 1
Granted
11 Medchew-1503
12 Dementia
$23.9 Bn (Global) by '28; 7.9% CAGR (m)
Pre-clinical
FDA Pre-IND
Phase 1
Granted
13 Medchew RL
14 Restless Leg Syndrome
12.1.% prevalence of US pop. (j)
Pre-clinical
FDA Pre-IND
Phase 1
Granted
15 Medchew Dronabinol
16 Nausea and Vomiting in
$3.1 Bn (Global) by '24 (e)
Phase 1A completed
FDA Pre-IND complete
Phase 1B
Granted
17 Chemotherapy
18 19 APIRx 1505 Flotex
20 Gastro: Chrohn's Disease
$12.6 Bn (Global) by '24 (k)
Pre-clinical
Pre-regulatory
Phase 1
Drafting
21 CanChew Plus
22 Gastro: IBS
$40 Bn (U.S.) in '21 (d)
Phase 2A Completed
Pre-IND, ethic's approval
Phase 2B
Granted
23 CanChew RX
24 Gastro: IBD
$2.7B Bn (U.S.) by '28 (r)
Pre-clinical
Pre-regulatory
Phase 1
Granted
25 SuppoCan (Suppository)
26 Gastro: IBD
$2.7B Bn (U.S.) by '28 (r)
Pre-clinical
Pre-regulatory
Phase 1
Granted
27 Oraximax
28 Gingivitis and Periodontitis
$42 Bn (U.S. and Europe) in '21 (a)
Clinical Stage
510K pre-market
Phase 2
Granted
29 submission to FDA
30 31 CheWell
32 Addiction: Cannabis
$64 Bn (U.S.) in '21 (c)
Pre-clinical
Pre-IND ready for
Phase 1
Drafting
33 Dependence
submission
34 35 CanQuit
36 Addiction: Tobacco Smoking
$47.75 Bn (Global) by '24, 17.3% CAGR (o)
Pre-clinical
Pre-regulatory
Phase 1
Granted
37 Cessation
38 CanQuit O
39 Addiction: Opioid Addiction
$64 Bn (U.S.) in '21 (c)
Pre-clinical
Pre-regulatory
Phase 1
Granted
40 APIRx-1601
41 Skin: Vitiligo
$0.1B (Global) in '21 (b)
Phase 2 complete
Pre-IND drafting
Phase 1
2x granted, 1x
42 pending
43 44 APIRx-1602
45 Skin: Psoriasis
$0.5B (Global) in '21 (b)
Phase 2A complete
Pre-IND drafting
Phase 1
2x granted, 1x
46 pending
47 48 APIRx-1603
49 Skin: Atopic Dermatitis
$1.1B (Global) in '21 (b)
Phase 2A complete
Pre-IND drafting
Phase 1
2x granted, 1x
50 pending
51 52 APIRx-1701
53 Opth: Glaucoma
$10.4B (Global) by '26, 6.3% CAGR (g)
Pre-clinical
Pre-regulatory
in vitro studies
Granted
54 APIRx-1702
55 Opth: Dry Eye Syndrome
$6.6B (Global) by '27, 6.4% CAGR (p)
Pre-clinical
Pre-regulatory
in vitro studies
Granted
56 APIRx-1801
57 Ultrapure THC
$31.5 Bn (Global) by '30; 18.6% CAGR (q)
Developed
Granted
58 APIRx-1802
59 Ultrapure CBD
$31.5 Bn (Global) by '30; 18.6% CAGR (q)
Developed
Granted
60 APIRx-1803
61 Ultrapure CBG
$31.5 Bn (Global) by '30; 18.6% CAGR (q)
Developed
Granted