UPDATE2: Abbott, Gilead impress with upbeat results for oral hep C drugs

Abbott Laboratories ($ABT) shed more light on a promising mid-stage study of its interferon-free treatment for hepatitis C, showing the company is among the leaders in the crowded race to advance new all-oral therapies against the liver-damaging virus. After impressing analysts with topline results last month, Abbott revealed today that its triple-combo of antiviral drugs offered slightly better efficacy when given with ribavirin than without in its Phase IIb "Aviator" study.

Abbott reaffirmed that its Phase III program will test its three drugs with and without ribavirin, which is part of the standard of care for hepatitis C, The virus afflicts an estimated 170 million people worldwide and leads to liver cancer and other liver problems. The Abbott Park, IL-based drugmaker has quickly gained on Gilead Sciences ($GILD) in the contest to be first to market with all-oral therapies, which are expected to fuel a market potentially exceeding $15 billion within a few years of becoming available. 

The bottom line is that there's huge expected demand for oral therapies that can quickly wipe out hep C without need for interferon, the injected drug that patients with the disease now take for up to a year and is tied to flu-like symptoms and other nasty side effects.

Abbott, which is one of the closely watched companies this week at the American Association for the Study of Liver Diseases' big Liver Meeting in Boston, provided the following details on the sustained viral response rates 12 weeks after treatment, or SVR12, for hepatitis C patients on its three antivirals (including ABT-450/r, ABT-267, and ABT-333) and ribavirin:

- 97.5% in genotype 1 (GT1) patients who had not received prior hep C therapies or treatment-naïve patients and 93.3% in GT1 patients who failed prior therapy or null responders.

- 96% in GT1a patients who were considered treatment-naïve and 89% of GT1a patients who were null-responders.

- 100% in GT1b patients who were treatment-naïve and 100% in null-responder patients with GT1b disease.

Here are the SVR12 results from the same study in treatment-naïve patients on Abbott's three drugs--without ribavirin:

- 87.3% in GT1 patients

- 83% in GT1a patients

- 96% in GT1b patients

"The 93.3 percent SVR12 seen with triple-DAA therapy with ribavirin in previous null responder patients in Aviator is noteworthy given the limited treatment options with interferon-based therapies for this patient population," said Dr. Scott Brun, Abbott's divisional vice president of infectious disease development, said in a statement. "As the data from the Aviator study have matured, we are encouraged that we have continued to see high SVR12 rates. Results from Aviator have allowed Abbott to confidently move into larger, confirmatory Phase 3 trials with the goal of being the first company to bring an interferon-free treatment regimen to genotype 1 patients."

There appeared to be no safety red flags in Abbott's Aviator study (at least relative to the safety disaster in Bristol-Myers Squibb's study that prompted the company to write off most of the $2.5 billion it spent on Inhibitex). Abbott says that 1 percent of patients, or four of 448, in the 8- and 12-week arms dropped out of the trial because of adverse events. There were 5 serious adverse events, including one cases of joint pain that could have been drug-related. Otherwise, common side effects included fatigue and headache for a minority of patients in the trial.

Abbott's experimental protease inhibitor, ABT-450, was discovered with its collaborator Enanta Pharmaceuticals (a 2012 Fierce 15 company) and is being tested with the HIV medicine ritonavir.

- here's Abbott's release
- see Reuters' article

Special Report: Enanta Pharmaceuticals – 2012 Fierce 15

For more:
Abbott's interferon-free hep C combo wows in PhIIb test
Abbott wows the crowd with promising Phase II hep C data
Hep C drug deal frenzy can't be slowed by growing doubts

Gilead's oral combo shows 100% viral response in subset of hep C patients

Gilead Sciences ($GILD) highlighted an impressive result of its mid-stage "Electron" study of its own interferon-sparing approach to combating hepatitis C virus. The company said that 100% of genotype 1 patients had no detectable signs of the virus 4 weeks after a 12-week course of therapy on its nucleotide drug called sofosbuvir or GS-7977 and the NS5A inhibitor GS-5885 and the standard therapy ribavirin.

Foster City, CA-based Gilead jumped ahead in the hep C race with its $11 billion buyout of Pharmasset and its prized GS-7977. And expectations are high for the company, which is the largest maker of HIV drugs, to be a dominant force in the market for all-oral therapies for hep C. But also in the chase are Abbott, Bristol-Myers ($BMY), Vertex Pharmaceuticals ($VRTX), Boehringer Ingelheim and others. 

Gilead wants to revolutionize the treatment of hep C--which now requires treatment with the injected immune-booster interferon for up to a year--with a single combo of GS-7977 and GS-5885. The company has begun a Phase III program, dubbed "Ion-I," in which the company treats some patients with the two-drug combo and others with the combo and ribavirin. The drugmaker has made combos of antivirals into blockbuster successes in HIV and wants to do the same in the massive hep C market.

"This data exceed investor's recently elevated expectations (we believe whispers were for an SVR rate of 95%) and further establish GILD as the company to beat in the development of interferon-free HCV regimens," Phil Nadeau, an analyst for Cowen, wrote in a note to investors Monday morning.

- see Gilead's release
- read Adam Feuerstein's article

For more:
Vertex surges as rival hep C contender plays catch-up in clinic
Gilead preps late-stage sprint on blockbuster hep C studies

Gilead and Bristol combo shuts down hepatitis C in study

Gilead Sciences' ($GILD) and Bristol-Myers Squibb's drugs in combination showed impressive results in a study of patients with multiple genotypes of hepatitis C virus. The data follow Gilead's refusal to accept Bristol's invitation to pursue later-stage study of the two companies' oral compounds as Gilead plows ahead with Phase III development of its own antivirals.

At The Liver Meeting in Boston on Saturday, a late-breaking abstract showed that and impressive 100% of 28 patients with genotypes 1,2, and 3 had a sustained viral response 12 weeks after a 24-week course of treatment on Gilead's sofosbuvir or GS-7977 and Bristol's daclatasvir.

We may not have heard the last of doctors criticizing Gilead for spurning Bristol-Myers' invitation for further study of their respective treatments in combination. However, Gilead has been building an impressive case for a cocktail of its own oral meds, including GS-5885 and GS-7977, which the company is studying in combination with and without ribavirin in a late-stage trial.  Both GS-5885 and  Bristol's daclatasvir target the NS5A protein to combat the virus.

"Based on the results of ELECTRON and other Gilead phase 2 studies involving 5885, we remain confident in the potency and tolerability of 5885," Cara Miller, a spokeswoman for Foster City, CA-based Gilead, said in an email. She added: "Our priority is to advance an all-oral regimen for patients as quickly as possible and we believe this combination allows us to rapidly move forward toward that goal."

As Vertex Pharmaceuticals ($VRTX), Johnson & Johnson ($JNJ) and others are joining forces to study combos of their antiviral compounds, Gilead has been focused on advancing combos of its proprietary pills. It has invested a hefty sum for its pipeline of hep C drugs, most notably with its $11 billion buyout of Pharmasset announced last year to acquire 7977 or what it's now calling sofosbuvir.

Bristol, on the other hand, endured a major setback in the development of all-oral hep C drugs this summer when patients on the drug from its $2.5 billion buyout of Inhibitex earlier this year suffered severe side effects. The disaster caused Bristol to write off most of the purchase amount.

Boehringer Ingelheim targets Phase III with hepatitis C pills

Eyeing a stake in future market for all-oral hepatitis C therapies, Boehringer Ingelheim is setting out to begin late-stage development of an interferon-free combo for patients with the disease.

The German drugmaker said the Phase III study will begin shortly to test the same all-oral regimen studied in its Phase IIb trial, called "Sound-C2," complete results of which are being presented in Boston, where the annual American Association for the Study of Liver Diseases or Liver Meeting is under way. The combo consists of Boehringer's protease inhibitor, faldaprevir, and its polymerase inhibitor, BI 207127, and the standard antiviral for hep C, ribavirin.

In the Sound-C2 study, Boehringer's combo achieved a 69% viral cure rate in hep C patients who had not received the standard of care for the disease. The company plans to report full details of the 362-patient study at the Liver Meeting, where rivals such as Abbott and Gilead are unveiling their own impressive data to establish themselves as leaders in the crowded field.

Boehringer, which is already in late-stage development with an interferon-inclusive option, noted that patients studied in the Phase IIb trial have a form of the virus that is historically difficult to treat. Gilead and Abbott are also advancing their oral combos for patients with genotype 1 disease, which is the most common form of hepatitis C in the Western World.

- here's Boehringer's release
- see Reuters' article

Editor's Note: BI asked that we change the cure rate figure from 70%, the number from its press release today, to 69%, which is the correct number. We've updated this report accordingly.

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