In June 2009, we announced positive results from our Phase 2 clinical trial of three oral doses (200, 300 and 400mg once daily) of Tedizolid phosphate (TR-701), formerly Torezolid phosphate, administered for five to seven days in patients with complicated skin and skin structure infections, or cSSSI. In the clinically evaluable (CE) patients, the cure rate was 96% overall and 98% for the 200mg dose, which we have selected for our Phase 3 clinical program in acute bacterial skin and skin structure infections (ABSSSI), a new classification for cSSSI. The majority of patients in this trial were diagnosed with MRSA infections, of which 100% receiving the 200mg dose were cured. The clinical cure rates for the clinically evaluable and microbiologically evaluable (ME) groups were consistently high across all dose groups, with the cure rate at 200 mg similar to the cure rates at the 300 mg and 400 mg doses. The following table shows group cure rates by dose.
The severity of infection did not affect the clinical cure rate whether measured by type of syndrome, presence of systemic sign of infection or diameter of lesion. The following table shows the breakdown of clinical cure rate by clinical syndrome, systemic sign of infection and lesion size.
These results, together with those from completed Phase 1 clinical trials, demonstrated that Tedizolid Phosphate (TR-701) was highly effective against gram-positive pathogens, including MRSA, and could be dosed once daily for a course of therapy of one week or less and had a favorable safety and tolerability profile.