Critical Pharmaceuticals, a Nottingham, U.K.-based biotechnology company, has successfully completed a second clinical study on its CP024 growth hormone nasal spray.
The results of the 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. CP024 strongly induces the production of insulin-like growth factor (IGF-1), which is the principal mediator of growth hormone activity.
“As well as providing an attractive alternative to injection, we believe CP024 may have clinical benefits by reducing circulating growth hormone levels which reduce insulin sensitivity seen with current treatments of growth hormone while maintaining therapeutic IGF-1 levels,” said Dr. Gareth King, CEO Critical Pharmaceuticals.
In the clinical trial, six dose levels of CP024 (between 2-6mg 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 0.75mg Omnitrope.
Results confirmed that 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 also highly reproducible and showed a linear dose response indicating that it would be possible to accurately set and titrate dose in children and adults. Furthermore, the 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.
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. Critical Pharmaceuticals has pending patents in major territories for CriticalSorb and its CP024 nasal growth hormone product.
CP024 has been developed with funding support from the Wellcome Trust.