Enanta Pharmaceuticals Announces 96 Percent SVR12 in Treatment Experienced Genotype 1 Hepatitis C Patients in SAPPHIRE-II Study
ENANTA PHARMACEUTICALS INC (NASDAQ:ENTA)
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Today : Tuesday 10 December 2013
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- Second of Six All-Oral, Interferon-Free Phase 3 Hepatitis C Studies Using Regimen Containing ABT-450
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) today announced results from the SAPPHIRE-II study, the second of six phase 3 registrational studies being conducted by AbbVie for the treatment of hepatitis C virus (HCV) genotype 1 (GT1) infection, using a regimen containing Enanta’s lead protease inhibitor ABT-450. ABT-450 is part of AbbVie’s investigational three direct-acting antiviral (3D) regimen, consisting of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. The SAPPHIRE-II study used this 3D regimen plus ribavirin.
Results from the 394-patient SAPPHIRE-II trial demonstrated a sustained virologic response at 12 weeks post-treatment (SVR12) of 96 percent in chronically infected GT1 HCV treatment experienced adult patients who had previously failed pegylated interferon and ribavirin treatment. Approximately 49 percent of these patients were prior null responders, namely patients defined as not achieving a significant reduction in the HCV virus during their prior treatment. The majority of patients were GT1a, considered the more difficult-to-treat subtype, and the SVR12 rates of GT1a and GT1b were 96 percent and 97 percent, respectively. These results were based on an intent-to-treat analysis and were achieved after 12 weeks of treatment. Virologic relapse or breakthrough was noted in 2 percent of patients receiving the 3D regimen plus ribavirin. The treatment regimen was well tolerated, with 1 percent of patients discontinuing treatment due to adverse events.
“The high SVR rates in this SAPPHIRE-II trial and
Could very well see $30 or higher if results are strong. Expect to see additional trial results over the next few weeks. ENTA is also presenting at another conference on December 3rd hosted by DB. Investors are starting to discover this company
ENTA holding first conference call on Monday
Very undervalued. As strong data comes in, the stock should go much higher. It's a hidden gem
CS on Sapphire-1
One Down, Five to Go; Phase 3 HCV Data Flow
Begins with Positive SAPPHIRE-1 Results
¦ Bottom line: In-line with our expectations, ABBV/ENTA reported impressive
results from the first of six phase 3 studies for its all-oral regimen to treat
hepatitis C (HCV). SAPPHIRE-1 data shows SVR12 rates of 96% in
genotype 1 patients (95% in GT1a and 98% in GT1b, respectively), with
virologic relapse/breakthrough occurring in only 1.7% of patients. Further
details will be presented at EASL in April 2014 and the company continues
to expect regulatory submissions to take place in 2Q14.
¦ Additional trials will provide more color on ABBV's/ETNA's competitive
profile. Over the next 6-12 months, we will see significant amounts of data
from both ABBV's/ENTA's and GILD's pivotal clinical trials, and this will help
to define the competitive landscape in this market (Exhibit 1 and Exhibit 2).
We continue to believe that GILD has the advantage in reducing the daily pill
burden (both in terms of number of pills and once-daily vs. twice-daily
dosing), and possibly excluding ribavirin and reducing the overall duration of
therapy. That said, we see ABBV/ENTA having a very competitive efficacy
and safety profile and think other dynamics in the marketplace (e.g.
formularies, breath of commercial infrastructure, etc…) can allow for
ABBV/ENTA to obtain 15-20% market share.
¦ Peak ABBV HCV opportunity at ~$2B. We see the overall HCV market
expanding from current levels with increased HCV screening/diagnosis and
availability of effective all-oral regimens. While the US/EU market
opportunity is more near-term for ABBV/ENTA, we believe the Japanese
market is also compelling with ABBV entering in 2017. We assume a 2015
launch in the US/EU with global sales approaching $2 billion by 2017.
¦ Good economics to ENTA on ABT-450. ENTA will receive =$195M upon
filing ($45M) and approval ($155M). ENTA also will receive tiered 12%-16%
royalty rates on sales attributed to ABT-450 (4%-5% on combination sales
Maybe this stock will finally wake up
Not for a development stage company with no drug on the market. The importance is placed on whether they have sufficient cash and the strength of their pipeline.
Silly analysis. This is a young bio play. Most investors don't care about earnings with these types of companies. Most of them have no earnings and are burning a lot of cash. What investors want to see is how much cash the company has which is a lot right now and the development of their pipeline which is exciting.
As i have said before, most bios are getting destroyed. There is a sector rotation out of bio plays. Many have dropped by at least 50%. SRPT is just one of many going down.
bios are melting down. they had a great run for a long time but now they are being taken to the woodshed. srpt is getting whopped like the rest of them. it's the market, not stock specific
Many of these stocks have been hammered over the last few weeks. Nothing wrong with SRPT imo. Look at stocks like ACAD, CLDX, PCYC, ONTX, NPSP, STML, ENTA, BMRN etc.
It's sad but it's true. I have seen many times where a news group that has decent influence will short a stock and then release an extremely negative article. The stock tanks and they cover. Look at QCOR and see what happened to them with streetsweeper. There are other groups that do this to stocks. Now you know why the little guy doesn't trust wall st
Adam Feuerstein @adamfeuerstein 9m
@sharkbiotech But each boy's 6MWT is compared against own baseline, so irrelevant unless they got really tall/short during study. $SRPT
Adam Feuerstein @adamfeuerstein 15m
@sharkbiotech I didn't realize each boy's legs changed length over the 96 weeks of the study. Must be another lie told by CG. $SRPT.
Adam Feuerstein @adamfeuerstein 17m
@sharkbiotech So... the new $SRPT bear thesis is the length of the boys' legs? Hmmm..