Jules Levin from NATAP on EASL day 3

EASL Day 3 Saturday

I am sitting here in the seating area adjacent to the poster session at EASL in Copenhagen after finishing my danish and coffee.Thats a joke, danish; all joking aside, the breads and danishes look delicious here, I can't eat them because if I start I can't stop and I have diabetes and I watch my diet, except when I don't. The weather is great here, its cool and sunny. I heard this is unusally nice weather, 2 years ago it snowed in April. Anyway, this is a nice place. All kidding aside the conference is hot, there are so many new drugs presented here it's exciting. This morning Debio presented data of their cyclophilin inhibitor in prior nonresponders and it didn't look good, but previously in naives it has shown potency, but the company is trying to better characterize its activity in treatment-experienced. They used a lead-in dosing and this appears to be better but we'll see if it has utility in treatment-experienced. Regarding its use in coinfection it has drug-drug interactions and can cause elevated bilirubin, which is why they down dosed. Otherwise the today's poster session was chock full of new data on new promising HIV drugs. Merck reported preclinical data on their polymerase inhibitor MK-3281. Virochem the company bought by Vertex showed -3.7 log reduction with their NNRTI in patients, now owned by Vertex, in their poster. Let's count telaprevir -4.45 plus -3.7 that's -8.2 logs, pretty good. Schering's new protease SCH900518 is boosted by 100 mg once daily of ritonavir making it a potent once daily protease. They presented initial data here for monotherapy and short term data in combination with peg/RBV and announced the study design for the next study which will include dose ranging of 100 to 600 mg of SCH900518 plus 100mg RTV. This afternoon in the final oral session at 4pm on new drugs we will see telaprevir in treatment-experienced nonresponders, the abstract reports a 39% SVR rate in nonresponders but this includes null responders. The biggest story here, I think, is the INFORM Study being presented this afternoon, because it is the first data looking at a combination of 2 new oral HCV drugs, polymerase R7128 plus ITMN191, a protease, both drugs being developed by Roche. Yesterday Intermune reported 14 day data on their protease ITMN-191 in combination with peg/RBV and it looked potent but the main appeal was it shoed a clean side effect profile. Roche will be exploring various combination regimens as they move ahead with the 4 HCV drugs they own including Pegasys plus copegus. Abbott presented posters today on 2 NNRTIs and yesterday Enanta presented in an oral presentation preclinical data on the protease Abbott is developing. The data shows the 2 proteases they have to be potent and can achieve high levels. I asked the Enanta researcher if the data suggests these drugs could due to high levels suppress telaprevir or other PI resistance and they said it could but they have to study it. Boerhinger Ingelheim had a poster today on the resistance profile for their protease which is in phase II study now thus there is no new data to present here but there will be later. But the presented the first poster on data in patients with their new polymerase inhibitor, which I reported the other day. Pfizer reported in a poster the other day their polymerase inhibitor in patients and this drug looked effective with a good safety profile.

In all there is a lot to be excited about and this feeling is in the air here. There is a lot of discussion between and among researchers, both academic and company, about how to proceed in development with all these drugs. As you know by now if you read my reports telaprevir & boceprevir are both in phase 3 and I think should be available in mid 2011 after FDA review and approval. Vertex has presented 62-67% SVR rates in treatment-naives in phase II in caucasians with 24 weeks therapy with telaprevir+peg/RBV, African-Americans are included in their phase III study. Schering reported 54% SVR rates with boceprevir with 28 weeks therapy, 56% with a 4-week Peg/RBV leadin, 67% with 48 weeks boceprevir+peg/rbv, and 75% with a 4-week peg/RBV leadin and 48 weeks of boceprevir+peg/rbv.

BMS is developing 3 antiviral HCV drugs, one is the NS5A inhibitor which they presented very early data on in patients at AASLD and it looked potent and they have another 2 HCV drugs in development, plus lambda peginterferon for which there was a poster here and I reported it already. GSK is als in the game, they bought Genelabs recently, who has a bunch of NNRTIs in development. Gilead has GS-9190 in development, it is a phase II study now, and I reported on that recently to. All NATAP reports are posted to the NATAP.org website. I look forward to reporting to you later today the INFORM data and the telaprevir data.

I return Sunday morning on a 9am flight to the Big Apple to see my white persian 4-pound cat pixie.
Jules Levin