Today, about one-third of the world’s population, or two billion people, carry the tuberculosis (TB) bacteria, although most never develop active TB disease. Studies estimate that 65 to 70 million people have active TB, there are 8 to 10 million new cases of active TB per year, and there are 2 million annual deaths.
Carol Nacy, Ph.D., became aware of the unmet medical needs of TB while working at the NIH. She knew that, in 1993, WHO declared tuberculosis to be a global health emergency, and she wanted to do something about it. After serving as executive vp and CSO at both EntreMed and Anergen, Dr. Nacy established Sequella in 1997.
“There was an obvious market need, and we decided to create a company to take on the challenge,” says Dr. Nacy, who became the full-time CEO in 1999. Initial funding came from a stock offering and government grants. To date, the company has received more than $50 million in funding, more than half from grants. Sequella has also received 124 patents with 55 more pending.
Sequella seeks to proactively address emerging health threats, according to Dr. Nacy. Through focused execution, clear commercialization pathways, and strategic partnerships, Sequella, which has 17 employees, intends to commercialize a broad product portfolio designed to treat global health threats with significant market opportunity. After commercializing its TB products, the company plans to accelerate the development of other preclinical candidates for select indications with unmet needs.
Because some TB vaccinations can produce false positives in testing, and because faster diagnosis of TB not requiring syringes or other complicated equipment could be critical in countries where the health system is already overburdened, Sequella’s first product is a noninvasive skin patch test called the TB Patch. The transdermal patch test for TB provides a “yes” or “no” result that “looks and feels like a poison ivy reaction,” says Dr. Nacy.
Testing with the TB Patch can be done at the point of care. It requires no specimen generation and provides results within four days with 80% sensitivity and 96% specificity, according to Alan S. Klein, evp.
The Sequella TB Patch delivers MPT64, a protein specific to all organisms that cause TB. In people with active, infectious TB, a localized immune response consisting of erythema and/or vesiculation appears three to four days after application to the skin. It is easier to use and provides a shorter time to diagnosis than currently available TB tests, Dr. Nacy reports. In addition, it enables physicians to avoid wasting time, resources, and medicine treating false positive cases, she adds.
Sequella’s patch detects only active tuberculosis. Currently, initial detection of tuberculosis infection is based on a skin test that does not differentiate between patients with active infection, who are infectious, and patients with latent infection, who are not infectious. In addition, people who have been inoculated with BCG vaccine, which is still being used in many developing countries to control tuberculosis, also test positive.
The TB Patch can be marketed currently in 133 countries. The TB Patch, which is expected to be available outside the U.S. beginning in 2009, could be used in tandem with existing diagnostics to speed diagnosis of TB that has spread outside the lungs, which usually requires slow-growing bacterial cultures.