Trial on new Kala Azar drug to begin at ICMR’s Patna research centre

The Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), one of the centres of the Indian Council of Medical Research (ICMR), got the nod on Saturday to begin the phase II clinical drug trial of a new Kala Azar drug, code-named LXE408, officials said on Sunday.

The RMRIMS will join the Kala Azar Medical Research Centre (KAMRC), a charitable trust in Bihar’s Muzaffarpur district, where the trial was initiated last August, said Dr Krishna Pandey, scientist-G and director of ICMR-RMRI centre at Agamkuan in Patna.

Dr Shyam Sundar, retired professor and head, department of medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, heads the KAMRC.

Muzaffarpur and Patna are the two locations in India the Drugs for Neglected Diseases initiative (DNDi), a Geneva-based organisation, has chosen to conduct the phase II trial of the drug. Novartis, a multi-national pharmaceutical company, is collaborating with the DNDi in research on the drug.

Phase I trial on healthy human volunteers was done in the US.

“The DNDi completed its three-day site initiation visit of our centre on August 5. Depending on the availability of patients, based on the inclusion and exclusion criteria fixed by the Drug Controller General of India, and their consent, we will begin the phase II trials shortly after finalisation of the randomisation list of patients,” said Dr Pandey, scientist-G of ICMR-RMRIMS, who is also the principal investigator of the drug trial.

The sample size of around 100 patients in the phase II trial is to ascertain the appropriate dosage of the drug under investigation.

“In this study, one set of adult Kala Azar patients will be administered a seven-day course and another set a 14-day course of LXE408, and compared with single-dose AmBisome injection, the current first-line treatment of Kala Azar in India,” said Dr Pandey.

The phase III trial to check for the efficacy and toxicity of the drug, will begin after completion of phase II trial in one more year. Thereafter, the final phase IV trial, which is post-marketing surveillance, will begin on a larger target group of 500-plus patients, he added.

The LXE408 is an oral tablet, believed to have better patient compliance due to a shorter regimen than the only available oral drug, Miltefosine, which is currently not being recommended as monotherapy for the treatment of Kala Azar in India. It is expected to change the way patients are now treated through injectables.

Kala Azar is a disease caused by an infection with protozoan parasite that enter the body through the bite of an infected female sand fly or ‘balu makhi’, as it is called in local parlance.

Bihar is among the four Kala Azar endemic states in the country. Jharkhand, Uttar Pradesh and West Bengal are the other three. With an average prevalence rate of 0.5 cases per 10,000 population, the Centre has set a target to eliminate Kala Azar by 2024. The criteria for Kala Azar elimination is to sustain a prevalence rate of up to 1 case per 10,000 population for three years.