Updated interim results from the Phase IIa dose ranging study ALS-022335, simeprevir and odalasvir for the treatment of genotype 1 hepatitis C virus (HCV), were announced at the European Association for the Study of the Liver conference in September 2016. The study showed a sustained virologic response at 12 weeks post treatment (SVR12) or longer of 100% for all patients (n=60) who received three drugs. Moreover, one cohort (n=20) showed 100% SVR12 following only six weeks of treatment.
A total of 80 patients were treated across four arms of the open-label study. The only arm in which patients did not achieve 100% SVR12 was one omitting simeprevir. SVR12 has been used as an approval endpoint (in addition to durability of response) for all the other recently approved HCV treatments.
A result of 100% SVR12 after only six weeks of treatment (n=20) is faster than has previously been seen for the other approved and development stage HCV treatments promoted by Gilead, AbbVie and Merck for genotype 1. Janssen has announced that the triple regimen will progress to a multi-genome Phase IIb study shortly and a Phase III study in early 2017.
The adverse event profile of the triple regimen was predominately mild to moderate in severity and consisted of reports of common ailments such as headache and fatigue. There was a single discontinuation due to a serious adverse event because of a benign type 1 atrioventricular block that was detected during routine cardiovascular monitoring, although there were no clinical symptoms and the patients went on to achieve an SVR12.
We have increased our valuation to $2.75bn or $20.15 per basic share, from $2.36bn or $17.30 per basic share. We have increased our predicted market penetration from 25% to 30% based on the prospect of a six-week treatment regimen reaching the market. This has increased our peak sales estimates for the combo from $3.5bn to $4.2bn. The company ended Q216 with $425m in cash and investments, which we expect to be sufficient to reach profitability.