Shareholders who took a punt on Argenica Therapeutics (ASX: AGN) when they made their market debut earlier this year will be pleased to read the Company’s roadmap to Phase 1 clinical trials.
The recently-listed Company has been subjected to the trials and tribulations of being listed, with a sharp sell-down post-IPO leaving their share price 56% lower than their price on debut. That being said, things are starting to trend upwards with the share price slowly (and I mean SLOWLY) increasing over the last two months.
The Company’s limited drug asset portfolio may be a limiting factor to some, but if it really is as good as the science indicates (thus far), that may not matter.
As biotech investors will know all too well, things don’t happen overnight. Drug development is a notoriously slow process with a high failure rate that can span anywhere from 7 to 11 years from invention to approval. Combine that with Argenica’s limited operating history and inevitable need for more capital in the near term and you can see that the investor wariness is not unfounded.
The presentation released by the Company this morning seeks to quell these concerns with a detailed timeline and plan to push their neuroprotective drug, ARG-007 through the trial process.
Designed to slow the effects of lack of oxygen to the brain during a stroke, ARG-007 has demonstrated promising results in preclinical models of stroke.
The neuroprotective compound could buy first responders time to get patients to hospital for diagnosis and treatment. And, considering someone has a stroke every 13 minutes, the need for such a drug is critical.
Currently, patients will receive medication or surgical intervention after doctors diagnose the type of stroke. However, the time taken to get to hospital and be diagnosed is critical as the rate of neural cell death rapidly increases. Applying a neuroprotective drug in the field or on arrival to hospital could significantly reduce the damage to brain tissue and improve patient outcomes in the long term.
The Company has partnered with leading clinical research facility Linear Clinical Research to begin the work towards Phase 1 in-human trials. Final pharmacokinetic studies in animal models are expected to yield results by early 2022. The data determining how the drug is absorbed, distributed and excreted by the body will inform dosing strategies for the in-human trial. The Company will also run a concurrent safety and toxicology animal study to characterise the drug’s safety profile and identify the impact on the body at differing doses. Results of this are expected in early 2022 as well.
Once pre-study activities for trial set up are completed the Company is hoping to commence their Phase 1 clinical trial in Q1, CY22. The trial will involve a small number of healthy volunteers who will receive the drug and provide data on its safety and tolerability, as well as the dosage to determine optimal safe dose for later studies.
Of the 15 million people who suffer a stroke each year, 5 million are permanently disabled and another 5 million die. Despite significant effort there is no neuroprotective agent on the market that seeks to protect brain cells. Stroke treatment is predominantly focused on the treatment and diagnosis of stroke, at a cost of $183 billion by 2030. Argenica’s drug could be a game changer, but investors will have to sit on their hands and wait for more results for a while before tapping in.