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Successful Completion of Second Clinical Trial on CP024 Intranasal Growth Hormone

Published: Wednesday, February 13, 2013
Last Updated: Tuesday, February 12, 2013
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Clinical trial results show that CP024 is safe and well tolerated with pharmacokinetics.

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.

Dr Gareth King, CEO Critical Pharmaceuticals commented “We are very excited about the latest clinical results with CP024 which provide clear proof of concept for this product, and which will support our search for a suitable development and commercialization partner to progress the product into phase 2/3 clinical studies. 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.”

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.

The need for new products to treat growth hormone deficiency
Human growth hormone (hGH) is a leading biological drug for the treatment of growth disorders in adults and children with global sales in excess of $3bn in 2011.

All marketed growth hormone products require subcutaneous injection and CP024 nasal growth hormone offers an attractive non-invasive route for delivery.

Non-adherence to hGH therapy is estimated to be as high as 66% with 70% of patients unhappy with daily injection and 30% considering stopping treatment. As well as reduced efficacy, non-adherence also leads to increased healthcare costs.

Nasal delivery provides an attractive alternative; studies show that for vaccine delivery, where there is a choice, children prefer nasal administration over injections.

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.

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