Following discussions and protocol agreement with the FDA, Samaritan will conduct an eight-week Phase II clinical study with SP-6310 in HIV-infected patients with abnormal cortisol levels while on antiretroviral therapy.
Samaritan expects that the results of this study will confirm the positive results found in a previously conducted Phase I/II.
Janet Greeson, CEO of Samaritan, said: “SP-6310 was born out of Samaritan’s intrinsic desire to bring significantly beneficial, affordable, first- and second-line treatment regimens to all suffering HIV patients, including those in the developing world. We believe SP-6310 has robust promise to do so.”