Delivering Advanced Therapeutics
CP024 Nasal Growth Hormone
CP024 is a nasal spray formulation of somatropin (recombinant human growth hormone). Clinical proof of concept has been established for CP024 and the CriticalSorb technology.
In Phase 1 clinical trials, CP024 was shown to be well tolerated and able to induce insulin‐like growth factor 1 (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. CP024 was also shown to exhibit linear pharmacokinetics which is important for accurate dose setting and titration.
Human growth hormone deficiency in children results in stunted growth and delayed muscle development and in adults in diminished lean body mass, poor bone density as well as a number of other physical and psychiatric symptoms. In addition to treating growth hormone deficiencies, somatropin is used to treat people with Turners syndrome and HARS, a syndrome associate with HIV infection, as well as certain other muscle wasting diseases due to its role in fat metabolism and muscle development. The market for somatropin products is currently estimated to be $3.1 billion annually.
Somatropin is not usually absorbed through the nasal mucosa. However Critical Pharmaceuticals’ proprietary CriticalSorb technology enhances the absorption of somatropin and thereby makes it possible to deliver the drug by nasal spray; greatly improving the ease of use for the patient compared to current treatments of daily injection.