The transition was stark. We were making a documentary with a team from DNDi on clinical trials in India. One day we were filming in a luxurious Delhi hospital catering for wealthy patients and foreigners; the next, we were in the middle of Bihar, one of India’s poorest states.

The Indian subcontinent (India, Nepal & Bangladesh) is one of the main areas affected by VL worldwide. It accounts for about 67% of total cases reported with almost 200 million people at risk of contracting the disease. The governments of India, Bangladesh and Nepal have launched a joint programme to eliminate VL as a public health problem by the year 2012.

Saisuru (the real name is not being used to protect the patient’s identity) is a seven-year-old girl, living in the remote Sosak village 60km from Amudat Hospital - one of the research and treatment centres for the DNDi LEAP paromomycin project, overseen by Makerere University.

The goals of LEAP are: to facilitate clinical testing and registration of new treatments for VL (Ethiopia, Kenya, Sudan and Uganda); to facilitate the development of national treatment guidelines for East Africa; evaluate, validate and register improved options that address regional needs for VL; and provide capacity strengthening for drug evaluation and clinical studies.

Leishmaniasis is a poverty-associated disease with several different forms, of which the following two are most common:
• VL – fatal without treatment
• Cutaneous Leishmaniasis (CL) – has a spectrum of presentations, typically with self-healing or chronic lesions on the skin.

Drug discovery is basically a three-stage process consisting of screening, lead selection, and lead optimisation (LO). It is the first step on an uncertain journey towards getting medication to those who need it. The objective of these initial stages is to find a drug candidate i.e. a compound that can enter the clinical development process (clinical trials) after being evaluated for safety and efficacy in animals (preclinical development).

Lead optimisation (LO) involves taking a ‘lead’, or a molecule known to kill a specific parasite in both in vivo and in vitro assays, and optimising it by making chemical modifications that will optimise the molecule’s capacity to be absorbed into the bloodstream, be distributed effectively to the infection sites, survive in the body, and kill the parasite, and not be harmful when it reaches the patient.

A total of EUR12 M from 11 different donors has been used to develop the VL-specific portfolio of DNDi in our first five years of operation; this represents 25% of DNDi ’s total expenditure (EUR47.6 M) during that period.

DNDi aims to improve the quality of life and the health of people suffering from Neglected Tropical Diseases (NTD) and to ensure equitable access to new and field-relevant health tools. So what exactly is meant by “access”? What are the barriers to access for VL patients, and what strategies has DNDi put in place to deal with the access issues?