This past year was a seminal one for the TB Alliance, and for all those involved in the fight against TB.
In 2013, we have shown that regimen development is not only feasible, but holds the promise for rapid transformation of TB therapy. We completed 3 potentially landmark clinical trials this past year. The PaMZ regimen met its primary endpoint in an eight-week, Phase 2B trial, showing the potential to not only shorten therapy of drug-sensitive TB (something that has not been done for more than 40 years), but also to dramatically shorten and simplify therapy for many with drug-resistant TB. As we further evaluate the wealth of data from this trial, we continue the planning for the Phase 3 clinical trial as the final step on the path to global registration.
We have also shown that a second novel regimen, known as JPaZ, was extremely effective in its initial combination trial and will now progress to an eight-week Phase 2B study. This regimen includes two completely novel drugs, to each of which there is no pre-existing resistance, and has the potential to treat an even greater proportion of all TB patients, including some with highly resistant TB, in as little as a few months.
The global Phase 3 REMox TB trial was completed this past year as well, with results expected in early 2014. With those results, we will hopefully be in a position to roll out the first four-month treatment regimen for drug-sensitive TB, the most significant improvement in the therapy of the vast majority of TB patients in over 40 years.
TB Alliance has also made tremendous progress in a massively underserved area within TB — the therapy of childhood TB. In 2013, we began a comprehensive, multilateral collaboration to develop appropriately formulated first line TB treatments for children, while simultaneously preparing the market to ensure sustainable access to those treatments by all children in need.
We are extremely indebted to and thankful for our collaborators and donors as well as our dedicated staff who have been vital in furthering the realization of our commonly shared bold vision. We are, however, especially indebted to the thousands of patients who, over the years, have participated in our clinical trials. Without you, our work is not possible.
We are hopeful that 2014 will be another year of tremendous progress and change. We urge each of you to continue to pledge your partnership and support to the vision of a TB-free world.
We are extremely indebted to and thankful for our collaborators and donors as well as our dedicated staff who have been vital in furthering the realization of our commonly shared bold vision.
Dr. Mel Spigelman
President and CEO
TB Alliance |
Dr. Carlos Morel
Chairman of the Board
TB Alliance |