Ranbaxy Laboratories Limited (RLL) and Medicines for Malaria Venture (MMV) will provide an update on the progress and clinical development strategy of a promising, new antimalarial drug, designated RBx 11160, at a tropical disease symposium in Washington, D.C., December 14, 2005. RLL is developing RBx 11160 jointly with the Geneva-based MMV.
RBx 11160 is entering into phase IIb dose range studies in India, Thailand and Africa very soon after the successful completion of a phase IIa proof of concept study in October 2005.
RBx 11160 is the first synthetic peroxide antimalarial, and one that 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. One million people die from malaria every year; the majority of its victims are children under the age of five and pregnant women in developing countries, claims a Ranbaxy release.
Dr. Nilanjan Saha, head, clinical pharmacology and development at RLL, will present Ranbaxy's development strategy for RBx 11160 at the 54th Annual Meeting of the American Society of Tropical Medicine and Hygiene to be held in Washington, D.C. December 11-15, 2005 at the Hilton Hotel and Towers. The symposium, titled 'RBx 11160/OZ277 - The First Synthetic Trioxolane Antimalarial,' is co-chaired by Vijay K. Batra, head, generics, NDDS and Drug Development at RLL and Dr. J. Carl Craft, chief scientific officer of MMV.
Dr. Brian Tempest, CEO and managing director, RLL, said, "Ranbaxy is committed to help save lives from the worldwide scourge of malaria, and we therefore are doing everything we can to expedite the progress of RBx 11160 through all necessary clinical trials and regulatory reviews. Our goal is to bring this drug to market as quickly as possible at affordable prices to developing countries, and exchanging information on our progress at symposia like these helps to facilitate the process and encourage our efforts."
"We've known that artemisinin-based drugs are an effective treatment for malaria, but these naturally derived drugs are costly to prepare and are beyond the financial reach of millions of malaria victims in poor countries. RBx 11160 gives these people hope as it provides an impressive anti-malarial effect, but at a more affordable and lower cost," said William N. Charman, Monash University in Australia, another presenter at the symposium.
As a totally synthetic antimalarial molecule, RBx 11160 could replace artemisinin, a natural chemical derived from a scarce and expensive plant, because bulk production of RBx 11160 is expected to be faster and more economical compared with the existing, agriculture-based artemisinin derivatives, currently grown in the fields of China. Being a drug with short half-life, RBx 11160 will be combined with another long-acting drug, piperaquine phosphate (PQP), to comply with the current World Health Organisation (WHO) guidelines for development of new anti-malarial compounds.
"We desperately need more and better ammunition to fight this persistent killer. MMV is proud to be working on this exciting project with Ranbaxy. The progress made so far signifies how effective partnerships can accelerate drug development for neglected diseases," said Dr. J. Carl Craft, CSO of MMV.
The release further stated that RBx 11160 has been found to be well tolerated at up to 600 mg administered as a single dose and at up to 200 mg administered as single daily dose for seven days in healthy young subjects. This finding emerged from phase I clinical trials in healthy young and elderly volunteers conducted at the Guy's Drug Research Unit, Quintiles, UK.
A proof-of-concept (POC) study has recently been successfully completed in Bangkok, Thailand in 72 patients suffering from acute uncomplicated P. falciparum malaria.
A dose ranging study is to be initiated soon to evaluate the effect of RBx 11160 in more than 250 patients suffering from acute uncomplicated P. falciparum malaria. These patients will be enrolled at clinical trial centers in Thailand, India, Tanzania and Zanzibar.
Per WHO guidelines on development of new anti-malarials, the short and rapidly acting
RBx 11160 has to be combined with a long acting molecule when used in patients. Piperaquine phosphate (PQP) has been chosen as the partner molecule. Safety and tolerability date of a wide range of doses of PQP will be generated in a well-controlled Phase I clinical trial expected to begin in Switzerland in 2006.
Simultaneously, Ranbaxy will start work on developing a parenteral formulation of RBx 11160 for the treatment of severe and complicated P.falciparum malaria. Clinical development is expected to begin once an Investigational New Drug application on the parenteral formulation is filed in 2006, added the release.
Ranbaxy expects to file a new drug application (NDA) for a combination of RBx 11160 and PQP in early 2009. This product is intended to be made available for the treatment of acute uncomplicated P. falciparum malaria.
Once approved, Ranbaxy plans to make the drug available in malaria-affected regions of Asia.