Critical Pharmaceuticals, an emerging biotechnology company and PolyTherics Limited (PolyTherics), innovators in precision improvement of proteins and peptides, announced a collaboration to develop a novel injectable sustained release drug delivery system for a high value biological drug. The companies has been awarded a grant from the government-backed Technology Strategy Board to develop the technology and prototype drug.

The aim of the collaboration is to produce a clinically superior sustained release product that can be administered less frequently than currently marketed products with a potential reduction in side effects and improved overall efficacy.

Professor Lisbeth Illum, chief executive officer of Critical Pharmaceuticals commented: “We are delighted to be working with PolyTherics to address a significant need for improved biotechnology products. The technology we develop together has the potential to create an enhanced delivery platform for a wide range of biological drugs that will provide an attractive alternative to frequent injections for patients, clinicians and healthcare providers.”

The project is scheduled to run for two years with a total budget of just under £700,000; the Technology Strategy Board will meet half the costs to support the development of the technology and a novel long acting product up to proof of concept in an established disease model.

Dr Keith Powell, chief executive officer, commented “This joint project gives us an opportunity to develop a unique technology and we are delighted to have received this additional support from the Technology Strategy Board to enable us to work with Critical Pharmaceuticals to produce a better product for patients”.

Critical Pharmaceuticals announces the results of a long-term preclinical study that confirms the excellent local tolerability of its unique and proprietary CriticalSorb nasal drug delivery technology. The emerging biotechnology company is now preparing to take the technology forward into a phase I clinical trial.

CriticalSorb is already used in a number of marketed drugs for intravenous and oral administration and the results of this study complete the toxicology package for the nasal route of administration.

CriticalSorb is a best in class absorption promoter that enables the nasal delivery of biological and challenging small molecule drugs. Biological drugs represent a $90 billion market, and yet nearly all need to be administered by frequent injection. It has the potential to transform the delivery of biological drugs by enabling non-invasive delivery that would be strongly preferred by patients.

Critical Pharmaceuticals is developing the CriticalSorb nasal delivery technology with support from a Wellcome Trust Translation Award. The first product to be developed using the technology is a nasal formulation of human growth hormone (CP024).

The toxicological study with CriticalSorb™ was designed to investigate the effects of repeated intranasal administration over a period of six months. No adverse responses were identified in clinical observations, bodyweight, food or water consumption, ophthalmoscopy, haematology, blood chemistry, urinalysis or necropsy. In addition, histopathology examination revealed no adverse health effect at any dose and a ‘No Observed Adverse Effect Level’ (NOAEL) was therefore considered to be the highest dose tested. In addition to the six month study on CriticalSorb and in preparation for an upcoming phase I clinical trial, Critical Pharmaceuticals has also completed a chronic study with repeated intranasal administration of CP024 over a period of 14 days that also shows excellent tolerability with no adverse effects reported.
Professor Lisbeth Illum, CEO of Critical Pharmaceuticals is enthusiastic about the excellent tolerability results with CriticalSorb “We have already demonstrated that CriticalSorb can achieve exceptional bioavailabilities for drugs that are difficult to deliver and these latest results confirm that CriticalSorb is well tolerated and doesn’t damage the nasal mucosa, something that has been a significant issue for other nasal delivery systems. We look forward to confirming these excellent results in clinical studies and to address the significant need for improved biotechnology products that provide an attractive alternative to frequent injection for patients, clinicians and healthcare providers.”

Critical Pharmaceuticals is developing a pipeline of unique biological drug products utilizing its proprietary drug delivery technologies. These technologies enable the development of sustained release injectable depot and nasal delivery of proteins and peptides and small molecular weight drugs.

The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities.