Yesterday, it was reported that Atxa Therapeutics, an Irish pharma tackling a form of cardiovascular disease, is on a mission to raise funds to support phase 1 clinical trials of their NTP42 drug. With investors and clinical trial sponsors already vocalizing their interest, the project appears to be off to a promising start. Founder and chief executive of the company, Prof Therese Kinsella, told The Irish Times that the funding was essential to clinical trials thought to start in the first quarter of 2021, with the remainder of the funds being used to secure marketing authorization for the drug once tested.
Axta Therapeutics’ compound looks to not only stop the progression of a cardiovascular condition called ‘pulmonary arterial hypertension’ (or PAH for short), but in fact reverse the overall effects of the disease. Affecting as many as 500,000 people worldwide, PAH is a
progressive disorder that weakens the inner muscle of our lung arteries and forces the heart to work harder to pump blood through the lungs. What happens if the condition is left untreated can be devastating. Often, patients are left with breathing difficulties and heart failure; with most people surviving no more than three years living with the condition.
There are a few treatment methods that can, thankfully, allow patients to extend their life expectancy significantly. Medications to prevent blood clots, diuretics to remove excess fluid in the body, and digoxin to slow down the heart rate and strengthen the heart muscle, are all available to those diagnosed. The main issue for research sites today not only lies in finding a cure, but in the cost of current medications. It’s estimated that PAH costs $6 billion every year to treat; and it might be that Atxa Therapeutics could help reduce these costs.
Obstacles in the way
It’s well known that trial recruitment is a daunting and stressful affair regardless of the therapeutic area you specialize in. This is why, on average, 86% of clinical trials fail to meet their patient recruitment targets. When it comes to heart health clinical research, an article published by the US Institute of Medicine (USIM) finds issues with recruitment and patient engagement begin with research sites. The report cites a lack of ‘clinical trial culture’, open communication, and patient trust in the medical community as only a select few of the patient recruitment challenges facing cardiovascular research today.
With an ongoing survey by Continuum Clinical finding, back in March, that 81% of research sites reported high levels of unwillingness by patients to continue with participation, it’s clear that a clinical trial recruitment crisis was sparked over the lockdown period. What this means is that the situation may be far worse than expected. These preexisting issues outlined by the USIM article must now be considered to have a far more severe impact on the clinical research industry than initially thought. As Swiss biopharma and industry giant, Novartis, was only a few weeks ago forced to halt their phase 1 clinical trials due to patient recruitment issues, clinical recruitment today is a minefield of error - even for the industry leaders!
While Atxa Therapeutics still has a grilling funding process ahead of them before any clinical research can get underway, the future looks bright for the ‘UCD Spinout’ company and for patients of the complicated disease. With the right funding by clinical trial sponsors, Atxa may be able to unlock the secret to reversing the life-threatening condition. To ensure that the trial recruitment process runs smoothly, however, the firm may choose to turn to patient recruitment companies for added security. As patient confidence reaches a record low, we can only wait and see how the pharma approaches this mountainous challenge; and how they overcome this may be the difference between a treatment and a cure for PAH.
Here at Citruslabs, we've created the ideal patient recruitment dashboard to help any researcher improve their current metrics. With over 3 million patients on record, we ensure research sites are connected to a thoroughly educated and engaged pool of participants; so, it is no wonder why we have such high patient confidence! Now, we would say that other models are available - but this would be a lie. In fact, unlike that offered by other patient recruitment companies, our easy-to-use dashboard is the first-of-its-kind for the market; giving researchers a unique insight into their patients’ wants and needs via industry-leading technology. The future of clinical recruitment starts here.
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