Investment required:£10m ‐ £20m

    Clinical/Healthcare
    Drug delivery platforms enabling non‐invasive intranasal or long‐acting injectable delivery of biologics

    Synopsis
    The company is a proprietary absorption promoter that has the potential to provide a viable alternative to injection for a wide variety of biological and challenging small molecule drugs. Critical Pharmaceuticals has used the technology to develop CP024, a nasal growth hormone product in Phase 1 development that has established clinical proof of concept for CP024 and the company technology. In the Phase 1 clinical trial, CP024 was shown to be well tolerated and able to induce insulinlike 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. In addition, Critical Pharmaceuticals has used the company technology in preclinical studies with risperidone (a small molecule anti‐psychotic), insulin (a small protein for the treatment of diabetes) and two partner programs with novel peptide drugs. The bioavailability of intranasal insulin using The company is approximately 100% relative to subcutaneous injection compared to <1% without the company. Furthermore, the absorbed insulin exerts a pharmacodynamic effect lowering blood glucose by a similar amount to that of the subcutaneous injection. The company is a pharmaceutically acceptable excipient approved by the FDA as generally regarded as safe (GRAS). It has a drug master file (DMF), and is used in currently marketed products as a solubility enhancer for intravenous and oral administration. In preclinical toxicology studies, the company has been found to be nontoxic and not irritating to the skin or eyes and was well tolerated by the nasal mucosa in acute, 14 day and 6 month repeated dose chronic toxicity studies. Furthermore it is not mutagenic to bacteria, mammalian cells and mammals, and no developmental toxicity or teratogenicity has been found. Using conventional manufacturing technologies and delivery devices, possible formulation presentations include liquid nasal sprays or powders for nasal administration. CriticalMix ‐ Critical Pharmaceuticals has developed CriticalMix as a one‐step, solvent‐free process that uses supercritical carbon dioxide to facilitate mixing of a therapeutic and a biodegradable polymer to generate drug‐loaded controlled‐release formulations.

    Stage ‐ Expansion
    CP024 has completed two Phase 1 clinical trials where our intranasal growth hormone has shown comparable activity to injection.
    CP046 is a nasal spray formulation of teriparatide (parathyroid hormone or PTH 1‐34) being developed in collaboration with the University of Nottingham for the treatment of osteoporosis.
    CP016 is a long acting injection of human growth hormone in preclinical development that uses our CriticalMix technology.
    CP018 is a long‐acting injection of risperidone that uses Critical Pharmaceuticals’ proprietary CriticalMix™ drug delivery technology. It is being developed as a once every two week injection. (Schizophrenia management)