AUS
NZ
UK
CA
USA
IND
Highlights:
- CUV has received encouraging outcomes from the first clinical study assessing afamelanotide as a treatment for a life-threatening brain injury.
- In the clinical study, five out of six patients receiving afamelanotide recovered well in the six weeks following their brain injury.
- Dosing frequency of afamelanotide did not cause any harm to patients.
- The Company plans further studies and regulatory interactions.
In a significant development, Clinuvel Pharmaceuticals Ltd (ASX:CUV) received positive results from the clinical study evaluating its drug afamelanotide in arterial ischemic stroke (AIS).
The open label final study (CUV 801), the first clinical study assessing afamelanotide as a treatment for a life-threatening brain injury was done on six adult patients. Of the total, five patients recovered well in the six weeks following their brain injury. The study revealed further data that demonstrated good tolerance of afamelanotide in patients with longstanding cardiovascular disease.
AIS represents nearly 85% of the estimated stroke cases worldwide and is a leading cause of long-term disability in the United States.
Also read: CLINUVEL PHARMACEUTICALS (ASX:CUV) Reports Strong Cash Receipts in December Quarter
Image source: © 2022 Kalkine Media®
Clinuvel Head of Clinical Operations, Dr Pilar Bilbao said, “Despite the considerable impact of strokes on individuals and society, the treatment options available, even at specialist stroke units, are tragically limited. We are seeking to prove that afamelanotide can provide a safe, effective treatment option which can improve the overall prognosis post-stroke and reduce patient disability long-term.”
You may read: IPD, MX1 & MDR: Three ASX health tech stocks with strong revenue in 3Q
According to Dr Bilbao, the first steps are to make sure intervention with afamelanotide is safe and doesn’t harm patients while obtaining objective measures of impact of treatment on the course of the patients’ disease. Both the outcomes have been achieved with CUV 801 and the company can now carry out further studies and regulatory interactions with a confidence that the drug performs as per expectations.
“The gain for stroke patients, but also for society as a whole, lies in the improvement in neurological functions, since the ability to resume independent living saves high costs to our healthcare systems,” Dr Bilbao added.
Stock information
Clinuvel has a market capitalisation of AU$797.48 million. As of 04 MAY, 11:29 AM AEST, shares of CUV were trading at AU$16.050.
