Clinical Research Services
Clarity’s clinical research services for peptide and antibody imaging are designed for biopharmaceutical companies that wish to characterise and de-risk their biological molecules by imaging in humans first, before a Phase 1. Clarity’s technology can be used to increase the likelihood of clinical response through patient selection and therapy monitoring. This will reduce trial size, budget and timelines, making trials shorter, cheaper and faster to market. Clarity can develop a PET imaging companion diagnostic for Phase 2 and Phase 3 trials.
Clinical Phase 0 Research Services
Clarity has established a clinical research service that is designed to transition promising antibodies and peptides from proof-of-concept in animals to proof-of-concept in humans. Imaging of new drugs is becoming increasingly important in drug development, as regulatory bodies require an increasing amount of data on drug targeting, localisation, accumulation and clearance.
Clarity’s clinical research service includes first-in-human imaging studies, or ‘Phase 0’ trials, to confirm mechanism of action or compare drug candidates. Phase 0 clinical trials are well suited to imaging antibodies and peptides and require lower patient numbers, non-GMP product in many cases, sub-therapeutic doses and less expense when compared to conventional clinical trials. They are designed to give a good indication of whether the biological molecule is targeted to the disease site and not elsewhere.
Clarity’s clinical Phase 0 research services include:
- Preclinical preparation for clinical studies, including preclinical antibody and peptide imaging, biodistribution and toxicology studies.
- Manufacture of final antibody or peptide imaging product
- Validated radiolabeling of antibodies and peptides in preparation for imaging
- Human imaging studies in patients
Phase 0 imaging studies in patients inform:
- Drug targeting
- Drug accumulation
- Drug clearance
The advantage of using Clarity’s Phase 0 clinical research service
Whole body PET imaging allows companies to understand the targeting, accumulation and clearance of their products in the entire body, but also, most importantly, in the disease sites. Human imaging data supplements traditional Absorption, Distribution, Metabolism, and Excretion (ADME) and Pharmacokinetic/Pharmacodynamic studies and adds significant value to preclinical and clinical drug development programs. From antibody and peptide imaging data, more informed decisions can be made on whether to further proceed with the development of the therapeutic candidate.
The Phase 0 process will also allow the assessment of the clinical utility of a biological drug candidate as an imaging product. In addition to mechanism of action data, a Phase 0 trial will also determine whether a radiolabelled version of a therapeutic product would be a useful ‘theranostic/companion diagnostic’ tool during clinical development. The imaging product has the potential to select patients or monitor therapy in your Phase 2 or Phase 3 trial. Clarity would be a natural partner to develop that ‘theranostic’ product due to its unique capabilities in that field.
‘Bailey et al., RNSH Australia’
Why Phase 0?
- Attractive timeframes utilising Australia’s favourable
- Quantitate targeting of the product in patients
- Non-GMP product in Australia
- Identify off target activity
- Indication of dose
- More accurate safety profiling, dose limiting organs
- Compare and select best candidate