MedCity News (10.01.12)
It has been more than 40 years since a new drug for tuberculosis (TB) has been approved by the FDA. A small Indiana biotech startup company, Aarden Pharmaceuticals, hopes to deliver a stable, oral drug that is taken once a day or less to help prevent patients from developing drug-resistant forms of TB, such as multidrug-resistant TB (MDR TB) and extensively drug-resistant TB (XDR TB). The TB community needs treatments that can be taken along with HIV drugs and that are stable and easier to take than the current drug regimen. The current regimen entails a cocktail of drugs that need to be taken for six to nine months—and which many patients do not complete.
Aarden’s new drug is designed to be used alongside other TB treatments, and aims to inhibit a set of previously undruggable targets called protein tyrosine phosphatases. “TB is unique—it actually hides inside cells of the immune system,” said Francis Burrows, the company’s chief scientific officer. “Once the body recognizes it, (TB) allows itself to be engulfed by immune cells, but it has all these mechanisms that it uses to survive inside the macrophage, like a parasite.” Aarden’s approach, according to Burrows, blocks several of the methods that TB bacteria use to hide inside cells.
Aarden tested the drug in guinea pigs, in combination with Isoniazid, the first-in-line medication in the treatment of TB. In the study, which was supported by the National Institute of Allergy and Infectious Diseases, the time to eradicate the infection with the new drug combination was half the eradication time when using Isoniazid alone, according to CEO Gary Noonan. In spite of the encouraging results, it is still early in the testing process, and much more work needs to be done before the drug can be tried in humans. Aarden’s next step is to advance the candidate into more elaborate toxicology studies, which, if all goes well, would allow the company to prepare and submit an IND (Investigative New Drug) application to begin human trials. However, to do that, the company needs a pharmaceutical partner to help with manufacturing and testing.
Noonan had originally said that he hoped to have a drug ready for IND-enabling studies by the end of 2011. That goal, he stated, may have been a little aggressive for Aarden. Now, Aarden’s timeline depends on its ability to find a partner. “The industry standard from when one initiates IND-enabling work to when it files is usually 12–18 months, but now our timeline on this is not our own—it’s the timeline of whoever we partner with,” Noonan added.