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news.Australian biotech Phosphagenics has reported that a Phase Ib trial for its needle-free insulin product met its primary endpoint of no adverse reactions.
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The company said that the positive results demonstrated the ability of Phosphagenics’s TPM technology to deliver insulin into the bloodstream in a non-invasive manner without causing any adverse events. Phosphagenics’ TPM-02/Insulin formulation is being developed as a novel “needle-free” way of administering insulin to patients with diabetes.
The Phase Ib trial, conducted at the Royal Adelaide Hospital in South Australia by CMAX, an independent clinical research organization, assessed the efficacy and safety of two TPM/Insulin formulations in 45 volunteers. Blood glucose, endogenous insulin and C-peptide levels were measured to assess efficacy.
Dr Esra Ogru, executive vice president of R&D at Phosphagenics, said: “The phase Ib trial showed that our TPM/Insulin formulation safely penetrated through the human skin and delivered insulin into the bloodstream over a sustained period of time, without causing adverse reactions.”
Phosphagenics intends to continue clinical development of its transdermal insulin and preparations are underway for a phase II trial to be conducted by CMAX at the Royal Adelaide Hospital.