InterveXion’s anti-METH therapies work by preventing the abused drug from rapidly reaching the brain in large quantities. These therapies involve antibodies that can “absorb” METH in the blood to block their rewarding effects and simultaneously reduce their detrimental health effects. In addition to reducing the acute effects of overdose, these antibodies may also be used in the chronic setting to help abusers overcome their dependency.
IXT-m200, an anti-METH monoclonal antibody
IXT-m200, a chimeric anti-METH monoclonal antibody (previously called ch-mAb7F9), is the most developed product in our pipeline. We have a Master Cell Bank of a CHO cell line that produces over 2 g/L of culture medium. Two GMP batches have been manufactured to produce the antibody for our clinical studies. InterveXion submitted the IND for this product in March 2012 and the Phase 1a safety study was completed in 2013. More details on the clinical trial may be found on clinicaltrials.gov and in the Stevens et al. paper published November 2014.
The next steps in the IXT-m200 development program include a Phase 2a clinical study in METH-using volunteers. This study, called STAMPOUT, will provide additional safety information and early efficacy data to support the use of IXT-m200 in long-term METH treatment programs.
IXT-v100, an anti-METH vaccine
Additionally, an anti-METH active vaccine product, called IXT-v100, is in early stages of development. InterveXion has completed IND-enabling toxicology testing and is currently preparing for GMP manufacturing and a PIND meeting with FDA.