After reporting amiable progress concerning its sleep apnoea drug IHL-42X just last week, cannabinoid drug development company Incannex Healthcare (ASX: IHL) has published positive results from its animal study into IHL-675A against sepsis-associated acute respiratory distress syndrome (SAARDS) – currently the leading cause of COVID-19 mortality, according to World Health Organisation statistics.
SAARDS is a condition that occurs when the immune system overreacts to an infection, producing excessive levels of “cytokines”, the signalling molecules that attract immune cells.
Elevated levels of these cells secrete an increasing number of cytokines, which creates a cascading effect dubbed as a “cytokine storm” and ultimately leads to damaged tissues and organs as the body is overrun with infection.
Incannex’s study was designed to test the responses of rodents with sepsis to varied doses of cannabidiol (CBD) and hydroxychloroquine (HCQ), a drug typically used to prevent and treat malaria but which has picked up headlines in recent weeks following US President Donald Trump’s declaration the drug could be used to treat COVID-19 sufferers.
Positive study results
Rodent cohorts were dosed with either CBD or HCQ in escalating doses, introduced to an inflammatory agent to induce sepsis and then had their blood sampled two hours later.
According to Incannex, the rodents’ response to CBD produced a bell-shaped dose-response curve.
Compared to the baseline result – untreated rodents with no induction of sepsis – CBD reduced cytokine levels by 31- 90% relative to the response created by the delivery fluid used to deliver the drug. Meanwhile, compared to the baseline rodents, HCQ reduced cytokine levels by 39-88%.
Incannex declared its “notable” results were achieved with a single dose after only two hours.
“The results from the study, using a well-established animal model of sepsis, are revealing and positive for the development of IHL-675A. The study has provided critical data that is informing the design of the combination product that will be tested in the next round of investigations,” Incannex Healthcare chief scientific officer Dr Mark Bleakley said.
Moving to stage two
Having completed the first phase of its animal study, Incannex announced the second stage will investigate the optimal inflammation dampening response of the IHL-675A combination drug in an in vitro study.
The company said the study is set to commence “imminently” with an approximate five-week run time.
Once results are received and processed, Incannex plans to launch a follow-up animal study to test optimal combinations.
Following the crushing effects of COVID-19 globally, several leading regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency(EMA) have launched emergency trial programs to develop an effective treatment against the virus.
Following several meetings with FDA consultants Camargo Pharmaceutical Services, Incannex said it has received their opinion that IHL-675A will be a strong candidate for FDA Emergency Use Authorisation, activated following the emergence of the COVID-19 pandemic.
The designation of Emergency Use Authorisation would facilitate an expedited investigational new drug (IND) meeting with the FDA, enabling the commencement of expedited clinical trials in which IHL can test IHL-675A in patients with COVID-19, the company said.
Given the rapid pace of developments surrounding its IHL-675A candidate, Incannex has confirmed it filed a provisional patent over IHL-675A for SAARDS on 15 April 2020.
In a statement, the company said the clinical objective of SAARDS treatment is the reduction of the acute pulmonary inflammatory response, reversal of pulmonary oedema, and limitation of damage to the lung.
“We’re delighted that the first set of clinical results we have received from across our four clinical programs are positive, facilitating our ability to move forward to the next step with confidence,” Incannex chief executive officer and managing director Joel Latham said.
“These results confirm our strategy to pursue cannabinoid-based clinical assets relevant to major markets in indications with unmet need and no registered pharmacotherapeutic options,” he added.