Critical Pharmaceuticals has announced that clinical data from it’s ongoing Phase 1 program on CP024, a nasal formulation of human growth hormone (hGH), has shown that CP024 is able to induce IGF-1 to the same levels as a subcutaneous injection of the marketed product.
IGF-1 is the main mediator of hGH activity in the body and a clinically relevant indicator of bioactivity.
Human growth hormone is a leading biological drug for the treatment of growth disorders in adults and children with global sales in excess of $3bn in 2010.
Current therapies all require daily injections that are strongly disliked by patients and their carers. CP024 has the potential to transform the delivery of hGH by enabling non-invasive delivery.
The ongoing Phase 1 program on CP024 was to evaluate the bioavailability, bioactivity and safety of two CP024 formulations administered intranasally to healthy volunteers relative to a subcutaneous injection of a marketed hGH product.
Professor Illum, the CEO of Critical Pharmaceuticals, stated “We are very encouraged with the interim results from our Phase 1 program that show for the first time that nasal administration of hGH is able to induce IGF-1 to the same levels as a subcutaneous injection. Importantly, CP024 has also been shown to be well tolerated in repeat nasal toxicological studies and in our first human clinical trial. We look forward to starting a Phase 1b study shortly and continuing the development of CP024 to bring intranasal hGH to patients as an attractive alternative to daily injection”.
CP024 has been developed using Critical Pharmaceuticals proprietary CriticalSorb™ technology, a best in class absorption promoter, and is supported by funding from the Wellcome Trust.