Second phase of trial of new kala-azar drug in progress at RMRIMS

Patna: The second phase of clinical trial of LXE408 drug for treatment of kala-azar has begun. Rajendra Memorial Institute of Medical Sciences (RMRIMS), Patna, a wing of the Indian Council of Medical Research (ICMR) is conducting the trial in collaboration with the Drugs for Neglected Diseases Initiative (DNDI). RMRIMS director Dr Krishna Pandey is leading the trial team comprising four doctors and other supporting staff.

The new oral drug has been developed by a pharmaceutical company and its phase I of trial was earlier conducted in the USA. A similar study on phase II was also in progress at Kala-azar Medical Research Centre (KAMRC), Muzaffarpur, by a team led by Prof Shyam Sundar.

Pandey, who is also the principal investigator of the drug trial team, said LXE408 is a new formulation supposed to have better patient compliance due to its shorter regimen in comparison to the hitherto only available oral drug Miltefosine, which is currently not being recommended as a monotherapy for treatment of kala-azar in India.

The phase II trial will be conducted on 100 kala-azar patients in Bihar, he said. A three-day intensive training session organised by the DNDI team at RMRIMS on the trial of new medicine concluded on Saturday. The trial would run under three arms - seven-day, 14-day and single dose mode against the Ambisome injection presently being used for treatment of this life threatening disease caused by a protozoan of genus Leishmaniasis transmitted through sand fly. Its most serious form is Viscera Leishmaniasis with symptoms of fever, weight loss and enlargement of liver causing other complications. If not treated on time, it may lead even to death.

He said clinical observation of all patients on trial, medically called initial care, would be made after 28 days to be followed by 180 days follow-up or final care. The total number of kala-azar patients in Bihar stood at 200 till July end, while it was around 100 in Jharkhand, added Pandey.