Case Studies
Helping clients with clinical trial design, regulatory hurdles and data translation
CASE STUDY 1.
Full-service design and implementation package: A Portuguese firm specialising in therapeutics for diabetic foot ulcers (DFU) required a full-service team to assist in the definition, design, approvals and implementation program for their product/s. The team successfully refocused the product on infections (DFI), designing an early and late-stage development plan including all documentation (synopsis, protocol, regulatory package). Preclinical data was re-examined, and further studies were mandated to support efficacy claims and to optimise dosing. Targetting DFI considerably raised the chances of a successful MAA. Options for multiple country trials and MAA were considered and researched re feasibility and likely outcomes with a view to accessing accelerated approvals programs.
Following a successful Scientific Advice meeting, clinical trials commenced in India, the EU and US. Currently in late phase, data is currently being collected and collated for analysis by IQ-IDM.
CASE STUDY 2.
Data analysis leads to positive stock exchange results: An Australian company developing an intranasal drug for seasonal viruses required a reanalysis of data following a lack of efficacy seen for the primary outcome. Following a data review statistically significant findings were evidenced for correlates, including pivotal clinical outcomes (symptoms). Re-targetting the drug towards prophylaxis of commonly-occurring, long-term adverse events associated with the infection was made possible. Earlier engagement with IQ-IDM could have further boosted both market size and sales potential.
On the basis of the findings the company was able to announce positive results on the ASX leading to share price rises, stability and a clear marketing and development program for the product.
CASE STUDY 3.
Accelerated development of cholera vaccine: A vaccine company developing a novel cholera vaccine for global release was looking for innovative approaches to speed up development. After assessment of the pre-clinical and early phase 2 immunogenicity data, we advised the company perform a Human Challenge Trial (HCT) to establish phase 2 proof of concept data. This would allow the company to have early efficacy data and to guide the design of the phase 3 pivotal trial. Our team prepared the US development strategy and assisted the client in the FDA meeting preparations.
We also advised the company on the selection of the clinical sites to perform the HCT trial.
CASE STUD4.
Scientific Consultancy for influenza antiviral: An Eastern European company with a marketed product in the ex-Soviet block was looking for support to develop this product as an influenza antiviral for the EU and US markets. Our team made an in-depth scientific assessment of the available preclinical and clinical data as well as the mechanism of action and advised on further non-clinical data required to initiate the clinical development for influenza. A parallel gap-analysis was performed to assess if a phase 1 study was required or could be omitted based on existing data with the marketed products.
Following regulatory feed back the company had clear path forward to start a phase 2 efficacy trial, initiating the US and EU development.
Our Story
Company History: CHIMunomics was born out of CHIMagents Ltd., a start-up providing challenge agent and controlled human infection modelling solutions to the wider CHIM industry. This company was acquired via a buy-out.
CHIMunomics Ltd. was founded in January 2023 after a number of key, senior industry professionals from a CRO joined forces to create a consultancy and clinical trial services to the infectious disease community.
Since that time there have been contracts with biotech and small pharma companies to assist in clinical trial design and implementation, drug development strategy, data analysis, project management and regulatory pathways.
Our Clients
