New anti-malaria drug to be tried in India

Posted AtNew Kerala.com

A cheaper anti-malarial drug being developed by India's Ranbaxy Laboratories Ltd (RLL) and Geneva-based Medicines for Malaria Venture (MMV) would soon be studied for its dose range in India, Africa and Thailand.

The RBx 11160 drug that promises hope for millions is the first synthetic peroxide anti-malarial drug being developed by MMV, a global collaboration in which Indian pharma major Ranbaxy is also partnering.

"RBx 11160 is entering into Phase IIb dose range studies in India, Thailand and Africa after the successful completion of a Phase IIa proof of concept study in October 2005," Ranbaxy said in a statement Tuesday.

As a totally synthetic anti-malarial molecule, RBx 11160 could replace Artemisinin, a natural chemical derived from a scarce and expensive plant.

The bulk production of RBx 11160 is expected to be faster and economical compared to the existing agriculture-based Artemisinin derivatives grown in China.

Ranbaxy said RBx 11160 would be combined with piperaquine phosphate (PQP) to comply with the current World Health Organisation (WHO) guidelines for development of anti-malarial compounds.

RBx 11160 has been found to be well tolerated at up to 600 mg administered as a single dose and at 200 mg administered as single daily dose for seven days.

This finding emerged from Phase I clinical trials in healthy young and elderly volunteers conducted at the Guy's Drug Research Unit in Quintiles, Britain.

A proof of concept study on the drug was successfully completed in Bangkok on 72 patients suffering from acute uncomplicated P. falciparum malaria.

If proved effective, "the drug could be produced inexpensively and quickly. It thus holds great promise for the millions of people in 90 countries who are afflicted with the disease", Ranbaxy said.

Every year about one million people die of malaria, most victims being children under the age of five and pregnant women in the developing countries.

"We are doing everything we can to expedite the progress of RBx 11160 through all necessary clinical trials and regulatory reviews," said Brian Tempest, CEO and managing director of Ranbaxy.

The dose ranging study is to be done on 250 patients of plasmodium (P) falciparum malaria at clinical trial centers in Thailand, India, Tanzania and Zanzibar.

Simultaneously, Ranbaxy will start work on developing a parenteral formulation of RBx 11160 for the treatment of severe and complicated P. falciparum malaria.

The Indian pharma major expects to file a New Drug Application (NDA) for a combination of RBx 11160 and PQP in early 2009.

Ranbaxy plans to make the drug available in malaria-affected regions of Asia, Africa and South America at an affordable price.

December 13, 2005