nasal device

Presentation of CP024 (Nasal hGH) Phase 1 Clinical Results at The Endocrinology Society Annual Meeting

Presentation of CP024 (Nasal hGH) Phase 1 Clinical Results at The Endocrinology Society Annual Meeting 07/06/2012 09:00

Critical Pharmaceuticals today announces that clinical data from it’s Phase 1 study of CP024 nasal human growth hormone (hGH), will be presented at The Endocrinology Society Annual Meeting in Houston, TX , on Monday 25th June 2012 by Dr Faron Jordan, Head of Preclinical and Clinical Development at Critical Pharmaceuticals. The oral presentation, entitled “Intranasal Administration of Human Growth Hormone (CP024) and Induction of IGF-1 in Healthy Volunteers” will be presented at 11:15 (Room 362, George R Brown Convention Centre).

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 2011. 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.

Dr Faron Jordan will present results from the Phase 1 study on CP024 to evaluate the pharmacokinetics (hGH), pharmacodynamics (IGF-1) and safety / tolerability of two CP024 formulations administered intranasally to healthy volunteers relative to a subcutaneous injection of a marketed hGH product. IGF-1 is a clinical relevant pharmacodynamics marker and the main mediator of hGH activity in the body.

Dr Gareth King, CEO Critical Pharmaceuticals said “The results from our Phase 1 study have demonstrated for the first time that intranasal administration of hGH is able to induce IGF-1 with CP024 achieving similar IGF-1 levels to a subcutaneous injection of marketed product. Importantly, CP024 was also well tolerated and demonstrated highly reproducible pharmacokinetics. We look forward to reporting the results of our second phase 1 clinical study that is currently underway to evaluate the dose response relationship of CP024 and IGF-1”.

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

CP024 Nasal hGH

measuring height

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

Read more

CriticalSorb Technology

nasal device

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

Read more

Dr Gareth King, CEO Critical Pharmaceuticals
“The results from our Phase 1 study have demonstrated for the first time that intranasal administration of hGH is able to induce IGF-1 with CP024 achieving similar IGF-1 levels to a subcutaneous injection of marketed product. Importantly, CP024 was also well tolerated and demonstrated highly reproducible pharmacokinetics. We look forward to reporting the results of our second phase 1 clinical study that is currently underway to evaluate the dose response relationship of CP024 and IGF-1”.