Multi-study advances HIV drug to Phase II quicker

Pharmaceutical Profiles of the UK has completed a groundbreaking study that bundles together a number of tests used to decide whether a drug development candidate is worth pursuing into a single clinical trial.

The exploratory study made use of Pharmaceutical Profile’s Enterion microcapsule technology, an electronic drug capsule that features a radiotracer and can be programmed to deliver its drug payload at specific points in the gastrointestinal (GI) tract.

The study also utilised the company’s IVmicrotracer, Pharmaceutical Profiles’ brand of microdosing trial in which patients receive subtherapeutic doses of a drug to generate pharmacokinetic and absolute bioavailability data without the time and expense of a full-blown oral/IV crossover study.

Extensive use of imaging techniques formed the third pillar of the trial, according to Andy Rankin, the company’s chief scientific officer.

“This study is at the very forefront of new thinking in drug development and shows what can be achieved with smarter design and integrated technologies,” he said.

“Clinical programmes can be progressed much more quickly and cost effectively through the early stages of drug development using these principles.”

The trial was carried out on a drug for HIV, the non-nucleoside reverse transcriptase inhibitor (NNRTI) RDEA806, which was developed by San Diego, US-based company Ardea Biosciences. The compound will shortly enter Phase IIb testing.

In one sngle study, Pharmaceutical Profiles assessed oral bioavailability, regional GI absorption, transit and degradation; absolute bioavailability and metabolite characteristics. Moreover, the study was granted approval by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in just 12 days without comment or amendment.

Ardea and Pharmaceutical Profiles will use the data to guide the development of effective formulations for Phase II trials and beyond.

It will also help the firms to develop techniques to establish in vitro/in vivo correlations (IV/IVC) as well as enable the pharmacokinetic/pharmacodynamic (PK/PD) modeling which underpins effective design and implementation of further clinical studies.

Dr Colin Rowlings, senior vice president, pharmaceutical sciences at Ardea, said: “This novel study integrated several design aspects in an efficient manner that are traditionally addressed in separate studies. The insight obtained has been very useful in identifying the optimal dosage form for RDEA806.”