Achillion and Janssen’s Triple Combination Therapy Achieves 100% Cure Rate in HCV-1- Janssen (JNJ) announced interim results from a Phase 2a trial evaluating a tripe combination therapy for the treatment of HCV. The results showed a 100% cure rate in as little as six weeks. The data will be presented at the European Association for the Study of the Liver Special Conference in Paris, September 23 - 24. The 20 subjects in cohort 1 received a daily dose of the combination of odalasvir (50 mg), AL-335 (400 mg) and simeprevir (100 mg) for eight weeks. All achieved clinical cure 24 weeks after completed therapy (SVR24). The 20 patients in cohort 2 received 800 mg of AL-335 every day and 50 mg of odalasvir every other day for eight weeks. The cure rate at 12 weeks post treatment (SVR12) was 90%. The 20 subjects in cohort 3 received 800 mg of AL-335 and 75 mg of simeprevir every day and 50 mg of odalasvir every other day for eight weeks. All achieved clinical cure four weeks after the end of therapy (SVR4). The 20 subjects in cohort 4 received the same regimen as cohort 3 but for only six weeks. HCV RNA was negative in 90% (n=18/20) and the other two were below the limit of quantitation at the end of treatment. AL-335 is a uridine-based nucleoside NS5B polymerase inhibitor being developed by Janssen unit Alios BioPharma. Odalasvir (formerly ACH-3102) is an NS5A inhibitor discovered by Achillion Pharmaceuticals (ACHN).
Lexicon’s Sotaglifozin Succeeds In Late-Stage Study- Lexicon Pharmaceuticals (LXRX) announced positive results in a 793-subject Phase 3 clinical trial, Tandem1, evaluating orally-administered sotagliflozin in type 1 diabetics. The study met its primary endpoint of a statistically valid reduction in HbA1c at Week 24 on a background of optimized insulin. Top-line data showed patients treated with a daily dose of 200 mg of sotagliflozin experienced a mean reduction in HbA1c from baseline of 0.43% compared to a reduction of 0.08% for placebo (p<0.001). Patients treated with 400 mg of sotagliflozin once daily experienced a mean reduction of 0.49% (p<0.001).
Auris Medical Makes Progress With Development of AM-111- Auris Medical (EARS) announced that it has reached the enrollment mid-point in its 255-subject Phase 3 study, HEALOS, evaluating AM-111 for the treatment of idiopathic sudden sensorineural hearing loss (sudden deafness). The company also reiterated its expectation that top-line results will be available in H2 2017. A second pivotal study, 300-subject ASSENT, was initiated in June. It is the same design as HEALOS, but with a Day 91 assessment of the primary endpoint of PTA. The estimated study completion date is June 2018.