At the same time, the company has secured a $2 million investment from a private investor to support the MDR-TB (multiple drug-resistant tuberculosis) drug development and clinical trial program.
Preparation of the investigational new drug (IND) application is well underway and submission is planned for later this summer. Phase I trials have been organized at several prospective centers both in and out of the US.
“We look forward to starting clinical trials to confirm in human trials the remarkable success the compound has demonstrated in the various in vivo models,” said Dr Albert Owens, FASgen’s president and founder.”FAS20013 is the first new therapeutic agent for the treatment of TB and MDR-TB to have demonstrated this level of potency and efficacy in the last 45 years.”
FASgen also announced that with MDR-TB listed by the US Department of Homeland Security (DHS) as a potential biological warfare threat, the company has submitted appropriate materials in support of funding to make the product available for the treatment of MDR-TB under the biodefense programs sponsored by the DHS.