Orphan status for Sequella's SQ109

Sequella, a Maryland, USA-based clinical-stage biopharmaceutical company focused on commercializing products to treat diseases of epidemic potential, says that the Food and Drug Administration and the European Medicines Agency (EMEA) independently reviewed its lead drug compound, SQ109 (N-adamantany1-N'-geranyl-ethylendiamine), with both agencies granting it orphan drug status for the treatment of tuberculosis. SQ109 shows excellent in vitro and in vivo activity against drug-susceptible and drug-resistant TB bacteria, including XDR-TB. Furthermore, the agent synergizes with other TB drugs in experimental animal models of the disease, and could result in new drug combinations that have much greater activity than the current standard-of-care products, the company says.

Carol Nacy, founder and chief executive of Sequella, said: "with the resurgence of TB in a new drug-resistant form, it is clear there is a need to readdress the treatment of this infectious and deadly disease. To accelerate our clinical programs, we will continue to work closely with the FDA's Office of Orphan Products Development and the EMEA's Committee for Orphan Medicinal Products as we move through the clinical and regulatory process."