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news.Modigene, a biopharmaceutical company, has reported positive results from a pilot toxicity study in primates designed to assess the safety of hGH-CTP, its long-acting human growth hormone, as well as to provide preliminary information on the approximate injection frequency that will be needed in human patients.
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The study was designed to elicit potential adverse effects from a single, very large dose of hGH-CTP, also known as MOD-4023. No adverse effects were observed, and the data from this study also support once-weekly or bi-monthly injection frequency in humans, the company said.
The pilot study included a group of primates that received a single injection of hGH-CTP containing a dose that was 1,040 times the daily dose of growth hormone recommended for use in human patients. No adverse effects were observed in any of the primates.
In addition, the half-life and area under the curve of hGH-CTP as measured in primates support a potential once-weekly or bi-monthly injection frequency in humans. This would replace the multiple injections per week that are currently required, as there is presently no long-acting human growth hormone (hGH) on the market, the company added.
Avri Havron, CEO of Modigene, said: Our long-acting hGH-CTP has exhibited excellent safety in all preclinical studies to date, so we were not surprised by these first data in primates showing that huge single doses of hGH-CTP appear very safe.
We also were pleased to report a significant increase in the half-life of hGH-CTP as we moved from rats to primates, in line with industry-accepted extrapolation models for the expected increase in the half-life of therapeutic proteins between these species. Based on the results of this pilot study, we anticipate that hGH-CTP could potentially achieve weekly or bi-monthly dosing frequency in humans.