nasal device

CP024 Nasal hGH Shows Comparable Bioactivity to Injection

Interim Results of CP024 Nasal hGH Phase 1 Program Show Comparable Bioactivity to Injection 06/09/2011 03:35

Interim Results of CP024 Nasal hGH Phase 1 Program Show Comparable Bioactivity to Injection

Critical Pharmaceuticals today announces 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.

About the Wellcome Trust

The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust’s breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests.www.wellcome.ac.uk 

CP024 Nasal hGH

measuring height

CP024 has completed two Phase 1 clinical trials where our intranasal growth hormone has shown comparable activity to injection.

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CriticalSorb Technology

nasal device

CriticalSorb enables the non-invasive nasal delivery delivery of high-value biologic products and challenging small molecule drugs.

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Professor Lisbeth Illum
“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”.