Date: 2013-02-12
Type of information:
phase: 1
Announcement: results
Company: Critical Pharmaceuticals (UK)
Product: CP024 (nasal formulation of human growth hormone [hGH])
Action mechanism: CP024 is a dry powder formulation of hGH containing CriticalSorb™ absorption promoter, a best in class nasal absorption promoter, and delivered using an easy to use nasal spray device. CriticalSorb™ is a marketed pharmaceutical excipient with an extensive toxicology package demonstrating its safety profile.
Disease: growth disorders
Therapeutic area: Hormonal diseases - Endocrine diseases
Country:
Trial details:
Latest
news: * On February 12, 2013, Critical Pharmaceuticals has announced that it has successfully completed a second clinical study on its CP024 growth hormone nasal spray. The results of this trial in healthy subjects showed that CP024 is safe and well tolerated with pharmacokinetics that are highly reproducible ensuring accuracy and ease of dose titration. Uniquely for a nasal formulation, CP024 strongly induces the production of insulin-like growth factor (IGF-1), which is the principal mediator of growth hormone activity. * On June 7, 2012, Critical Pharmaceuticals has announced 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 is entitled “Intranasal Administration of Human Growth Hormone (CP024) and Induction of IGF-1 in Healthy Volunteers”. 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. 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”.
In the clinical trial, six dose levels of CP024 (between 2-6 mg growth hormone) were administered to healthy subjects along with an infusion of octreotide to suppress the production of endogenous growth hormone. The objectives of the study were to measure the pharmacokinetics, pharmacodynamics and dose response relationship of CP024 compared to a subcutaneous dose of 0.75 mg Omnitrope®.
Results confirmed:
• CP024 was well tolerated and the few adverse events observed were mild and transient and similar to those observed with over the counter marketed nasal products (e.g. Beconase®).
• CP024 pharmacokinetics were highly reproducible and importantly showed a linear dose response indicating that it would be possible to accurately set and titrate dose in children and adults.
• Insulin-like growth factor 1 (IGF-1) was strongly induced after dosing with CP024 and is the only reported product to induce therapeutic levels of this important biomarker after intranasal administration. IGF-1 is produced in the liver in response to systemic growth hormone and is the principal mediator of its growth promoting effects. CP024 has been developed with funding support from the Wellcome Trust.
These latest results will support Critical Pharmaceuticals's search for a suitable development and commercialization partner to progress the product into phase 2/3 clinical studies.
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.
* On September 6, 2011, Critical Pharmaceuticals has announced that clinical data from its ongoing Phase 1 program on CP024 has shown that this nasal formulation of human growth hormone (hGH) is able to induce IGF-1 (Insulin-like Growth Factor-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. 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. The company now 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.
