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- Suda Pharmaceuticals (SUD) has received the final results for its canine trial of various oral formulations of anagrelide
- The Australian company specialises in reformulating drugs into an oral spray to improve bioavailability, or absorption into the bloodstream
- Suda is investigating alternate delivery of anagrelide for patients with metastatic cancer, as the drug in capsule form can induce increased heart rate and arterial pressure
- One of the three oral formulations tested showed a statistically significant increase in bioavailability of the drug and lower levels of the cardiac stimulator in the blood when compared to the capsule form
- The company will continue working to refine a pharmaceutical-grade formulation before undertaking pre-clinical toxicology studies
- Suda shares have been trading flat for 4.5 cents
Suda Pharmaceuticals (SUD) has received the final results from a canine trial of various oral formulations of anagrelide.
The Australian company specialises in reformulating drugs into an oral spray to improve bioavailability, or absorption into the bloodstream.
Suda is investigating an alternate delivery of anagrelide for patients with metastatic cancer with certain solid tumours, as the commercial capsule of the drug, Xagrid, can induce increased heart rate and elevated arterial pressure.
When the capsule is processed in the liver, a cardiostimulatory metabolite called 3-hydroxy anagrelide is produced which, in turn, increases heart rate and myocardial contractability.
The trial was conducted by contract research organisation Covance in the United Kingdom.
One of the three oral formulations, SS-101, exhibited a statistically significant increase in bioavailability of anagrelide and produced less cardiostimulatory metabolite compared to Xagrid.
The concentration of anagrelide in the blood was 43 per cent higher following administration of formulation SS-101 compared to the tablet form.
In addition, the concentration of 3-hydroxy anagrelide increased by 28 per cent in the novel formulation compared to 43 per cent in the parent drug.
None of the formulations caused any adverse cardiac effects or any irritation of the oral cavity.
The results added weight to Suda’s hypothesis that the drug could be delivered orally, as a safe and effective alternative to the capsule form.
Project director Dr Richard Franklin described the results as an exciting development for the anagrelide project.
“While we were hoping that all three of the oral spray formulations tested would have superior properties to the capsule form of the drug, we are delighted that one formulation, in particular, showed evidence of buccal absorption, increased bioavailability and reduced exposure to the cardiostimulatory metabolite,” he stated.
The company will continue working to refine a pharmaceutical-grade formulation before undertaking pre-clinical toxicology studies.
Suda anticipates it will require less pre-clinical testing than normal for the development of an oral spray as anagrelide has already received U.S. Food and Drug Administration and European Medicines Agency approval as a treatment of Essential Thrombocythemia.
The company also holds patents for anagrelide in Australia and Japan.
Suda shares have been trading flat for 4.5 cents at 1:20 pm AEST.
