Accelerating antifungal drug development

In common with other drug developments, antifungal drug development is a costly and time-consuming
business. Additionally, patients at risk of invasive fungal infection, or infected by Aspergillus, Candida,
Cryptococcus, Mucorales and other pathogenic fungi, can come from many different patient populations.

However, failure to diagnose patients with life-threatening invasive fungal infection at an early stage
contributes to the difficulty in recruiting patients into clinical trials. Also lack of microbiological confirmation
of infection results in loss of patients from evaluable populations, reducing the power of studies and increasing numbers needed for enrollment. Indeed, the absence of precision in endpoints, because of the paucity of
diagnostic markers, has resulted in many failed prophylaxis studies.

Molecular diagnostic tests will shorten clinical development timelines. Examples include:

• Provision of an additional microbiological endpoint in prophylaxis studies
• Faster recruitment because of greater sensitivity
• Confirmation of the diagnosis in patients recruited on radiological criteria alone
• Reduction in cases which provide no useful endpoint
• Alternative strategies for development based on ‘pre-emptive' molecular criteria.

Delayed studies results in the time to market being delayed and hence lost revenue. The integrated
use of molecular diagnostic tests for invasive fungal infections into Phase 2 and Phase 3 programs,
and expanding indications in Phase 4 studies, is clearly necessary.