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Currency in USD
Last close As at 07/06/2023
USD1.96
▲ 0.03 (1.29%)
Market capitalisation
USD124m
Research: Healthcare
Incannex has reported final results from its Phase I trial assessing the safety and pharmacokinetics (PK) of IHL-675A, a cannabidiol (CBD) and hydroxychloroquine (HCQ) fixed-dose combination drug, for the treatment of rheumatoid arthritis (RA). IHL-675A was generally well-tolerated and showed a comparable adverse event profile to reference drugs Epidiolex and Plaquenil. PK analyses revealed that CBD uptake was faster, and HCQ uptake was slower, for IHL-675A versus reference drugs. This could be advantageous for the combination drug, as CBD provides immediate relief for inflammation and pain in RA patients, and HCQ provides extended relief. In February 2023, Incannex initiated a blinded, placebo-controlled Phase II study for IHL-675A in RA. The company has also filed a pre- Investigational New Drug (IND) request with the FDA, intending to conduct parallel Phase II studies in the US. We view these results as encouraging for the clinical development of IHL-675A, provided data from Phase II studies continue to be supportive.
Incannex Healthcare |
On to Phase II for IHL-675A |
Clinical development update |
Pharma and biotech |
3 May 2023 |
Share price performance
Business description
Analysts
Incannex Healthcare is a research client of Edison Investment Research Limited |
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Incannex has reported final results from its Phase I trial assessing the safety and pharmacokinetics (PK) of IHL-675A, a cannabidiol (CBD) and hydroxychloroquine (HCQ) fixed-dose combination drug, for the treatment of rheumatoid arthritis (RA). IHL-675A was generally well-tolerated and showed a comparable adverse event profile to reference drugs Epidiolex and Plaquenil. PK analyses revealed that CBD uptake was faster, and HCQ uptake was slower, for IHL-675A versus reference drugs. This could be advantageous for the combination drug, as CBD provides immediate relief for inflammation and pain in RA patients, and HCQ provides extended relief. In February 2023, Incannex initiated a blinded, placebo-controlled Phase II study for IHL-675A in RA. The company has also filed a pre- Investigational New Drug (IND) request with the FDA, intending to conduct parallel Phase II studies in the US. We view these results as encouraging for the clinical development of IHL-675A, provided data from Phase II studies continue to be supportive.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
06/21 |
2.0 |
(8.2) |
(0.83) |
0.0 |
N/A |
N/A |
06/22 |
0.8 |
(14.9) |
(1.25) |
0.0 |
N/A |
N/A |
06/23e |
0.1 |
(20.7) |
(1.43) |
0.0 |
N/A |
N/A |
06/24e |
0.1 |
(33.4) |
(2.10) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.
Incannex reported final results from its Phase I trial assessing IHL-675A as a potential treatment for RA. In this study, three cohorts of 12 participants (n=36) received either IHL-675A, Epidiolex (CBD) or Plaquenil (HCQ). Measures of safety, tolerability and PK profiles were taken in the form of adverse event monitoring, and through blood samples for PK analysis, over a period of four weeks.
IHL-675A was found to be generally well-tolerated. The same number of treatment emergent adverse events (TEAEs) were reported for IHL-675A as with Epidiolex (33%). TEAEs included abdominal pain, dizziness, fatigue, frequent bowel movements, headache and somnolence. These were all reported as minor except for one case of moderately severe abdominal cramps, but this was resolved soon after onset. We note that the TEAE prevalence was lower with Plaquenil (13%) but acknowledge that the results were acceptable for the initiation of Phase II studies.
PK analysis showed the average maximum concentration (Cmax) of CBD from IHL675A was 1.57 times higher versus Epidiolex, and time to reach maximum concentration (Tmax) was 26% faster for IHL-675A versus Epidiolex. Further, the half-life (t1/2) of CBD from IHL-675A was 13% faster versus Epidiolex. Contrastingly, the Tmax for HCQ administered as IHL-675A was 46% slower versus Plaquenil, and HCQ clearance and total exposure was similar for the two drugs. These PK profiles may be considered favourable for IHL-675A, as CBD provides immediate relief for inflammation and pain, while HCQ is slower-acting and provides extended relief.
In our view, these results represent a key milestone for Incannex. We believe that the next catalysts for IHL-675A will be results from the ongoing Phase II trial, which involves a larger patient population (n=120), and the pre-IND request outcome from the FDA, which would enable Incannex to conduct parallel Phase II trials in the US.
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Research: Investment Companies
RTW Venture Fund (RTWVF) is focused on innovative biotech and medtech businesses that have clear pathways to delivering approved medicines and medical technologies to patients. It is managed by RTW Investments (RTW), a New York-headquartered, life sciences investment firm with offices in London and Shanghai. RTW takes a science-led, full-lifecycle approach to investing in both public and private opportunities, supporting companies at all stages of development via multiple capital solutions. Biotech stocks, in particular those of smaller-cap companies, fell out of favour in early 2021, but started to recover from mid-2022. RTW’s managers are hopeful that the sector’s positive fundamentals are starting to be appreciated again and that positive developments at portfolio companies will generate significant value for RTWVF’s shareholders. The fund’s largest holding recently received a takeover bid at a c 75% premium to its pre-bid share price.
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