The results demonstrated that PAC-113 is effective in the treatment of oral Candidiasis and compares favorably to the efficacy demonstrated by Nystatin, a current standard of care.
The Phase IIb dose-ranging clinical trial was a randomized, examiner-blinded, four arm, parallel design trial comparing three different doses of PAC-113 to Nystatin, consisting of two week treatment phase and two week post-treatment/follow up phase.
The dose-ranging trial involved 223 seropositive HIV patients with oral Candidiasis, and was conducted at sites in the US and South Africa. The objectives of the trial were to identify an optimal dose of PAC-113 from among the three doses studied, and to determine the relative efficacy of this PAC-113 dose as compared to Nystatin in eliminating clinical signs and symptoms of oral Candidiasis. Additionally, safety and tolerance and the microbiological response of Candida albicans to treatment were also measured.
The optimal dose of PAC-113 demonstrated a 34% increase in the primary endpoint efficacy level (complete clinical cure rate at day 19) for the per protocol analysis as compared to Nystatin, and a 50% increase in the corresponding intent to treat analysis.
Secondary efficacy endpoints showed similar trends among the three PAC-113 doses and the Nystatin group. Results also confirmed that PAC-113 was generally safe and well-tolerated.