Phosphagenics: Insulin Trial on Type 1 Diabetic Patients Completed
Human trial demonstrates ability to safely deliver insulin into patients with Type 1 diabetes.
Phosphagenics Limited has completed its transdermal insulin human trial which demonstrated that its TPM/insulin formulation safely delivered insulin into patients with Type 1 diabetes. The protocols were designed to meet the primary end point of evaluating the glucose lowering efficacy of transdermal insulin in patients with Type 1 diabetes and the secondary end point of safety and tolerability. The clinical results met both end points.
Assistant Professor William Hsu of the Joslin Diabetes Centre, Harvard Medical School, Boston, and medical scientific advisor to the company, said: “Phosphagenics has shown that its TPM/insulin formulation has the ability to deliver insulin into patients with Type 1 diabetes. I believe that the results of this trial are extremely encouraging and further development should be pursued by the company.”
According to the company, this is the first time ever that insulin has been delivered transdermally to patients with Type 1 diabetes without the use of a device. Prior to embarking on the research required to optimise its insulin formulation, Phosphagenics decided to conduct a trial to establish the viability of its current formulation to deliver insulin across the skin and into the systemic circulation of Type 1 diabetic patients.
In the next stage of its insulin development program, Phosphagenics will optimise its TPM/insulin formulation and this research, using a diabetic animal model, has already commenced with very promising results. Additionally the company will conduct a market research study among clinicians to determine the best form for the final commercial product. This may take the form of a gel, a patch, a spray or other device.
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