top-line safety and antiviral data from its ongoing clinical trial designed to evaluate additional doses of INX-189, an oral nucleotide polymerase inhibitor being developed to treat chronic infections caused by hepatitis C virus (HCV), administered as monotherapy or in combination with ribavirin (RBV) for seven days.
Inhibitex Reports Recent Clinical and Corporate Developments
AASLD: Antiviral Activity and Safety of INX-08189, a Nucleotide Polymerase Inhibitor, Following 7-Days of Oral Therapy in Naïve Genotype-1 HCV Patients - (11/07/11)
Inhibitex Commences Dosing of Phase 2 Clinical Trial of INX-189 in HCV Infected Genotype 2/3 Patients - (11/04/11)
Released: 11/29/11 07:00 AM EST
Inhibitex, Inc. (NASDAQ:INHX) (the "Company") today announced several recent clinical and corporate developments, including top-line safety and antiviral data from its ongoing clinical trial designed to evaluate additional doses of INX-189, an oral nucleotide polymerase inhibitor being developed to treat chronic infections caused by hepatitis C virus (HCV), administered as monotherapy or in combination with ribavirin (RBV) for seven days.
"We believe the significant increase in antiviral activity demonstrated with 100 mg INX-189 in combination with RBV, as compared to 100 mg INX-189 dosed as monotherapy, further confirms the antiviral synergy between INX-189 and RBV that we have consistently observed in preclinical and clinical results to-date," stated Dr. Joseph Patti, Senior Vice President and CSO of Inhibitex, Inc. "We look forward to further exploring this antiviral synergy with 200 mg of INX-189 and expanding the scope of our ongoing and planned Phase 2 clinical trials to include interferon-free combinations of INX-189 with other antiviral agents in HCV genotype 1, 2, and 3 patients in 2012."
Recent Corporate Developments
INX-189 for Chronic Hepatitis C - The Company today reported top-line safety and antiviral data from an ongoing Phase 1b extension trial of INX-189, which is designed to further evaluate the safety, tolerability, pharmacokinetics and antiviral activity of various doses of INX-189, administered as monotherapy or in combination with RBV, for seven days in treatment-naïve patients infected with chronic HCV genotype 1. In the ongoing trial, 100 mg INX-189, dosed once-daily for seven days in combination with RBV, continued to demonstrate potent and dose-dependent synergistic antiviral activity with a median HCV RNA reduction from baseline of -3.79 log10 IU/mL. Further, 100 mg INX-189 in combination with RBV was well tolerated and there were no serious adverse events. For comparison purposes, in a clinical trial completed earlier this year, 100 mg INX-189 dosed as monotherapy once-daily for seven days resulted in a median -2.53 log10 IU/mL reduction in HCV RNA levels. In this same clinical trial, the Company also reported antiviral data indicating that INX-189, when dosed once-daily at 9 and 25 mg in combination with RBV for seven days, demonstrated dose-dependent, synergistic antiviral activity.
The Company also reported today that, subject to regulatory review, it plans to further expand its ongoing Phase 1b extension trial to evaluate once-daily doses of 200 mg INX-189 in combination with RBV; 300 mg INX-189 as monotherapy; and 200 mg INX-005 (a single isomer of INX-189) as monotherapy, respectively, for seven days. The Company anticipates that the Phase 1b extension trial will be completed in the first quarter of 2012.
Additionally, the Company reported that it plans to submit a protocol amendment this quarter to its ongoing Phase 2 study in genotype 2 and 3 HCV-infected patients to include the evaluation of 100 mg and 200 mg of INX-189 dosed once-daily in combination with RBV for 12 weeks.
Financing Activity - The Company reported today that it had recently sold a total of 1,949,015 shares of common stock at an average price per share of $10.25 for total gross proceeds of $19,983,396 through its at-the-market (ATM) financing vehicle. The Company entered into a $20 million ATM financing arrangement with McNicoll, Lewis & Vlak LLC (MLV) in November 2010, which provides it the opportunity to sell registered shares into the open market through MLV from time-to-time under its effective shelf registration. After commissions, the Company received $19,383,274 in net proceeds. The intended use of the net proceeds is to support the expansion of the Company's planned Phase 2 program for INX-189 in 2012 and for general corporate purposes.
About Inhibitex
Inhibitex, Inc. is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company's clinical-stage pipeline includes two Phase 2 development programs for which it has retained all future rights: INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic HCV infections, and FV-100, a nucleoside analogue in development for the treatment of shingles-associated pain. The Company also has additional HCV nucleotide polymerase inhibitors in preclinical development and has licensed the use of its proprietary MSCRAMM¨ protein platform to Pfizer for the development of a staphylococcal vaccine, which is currently being evaluated in a Phase 1/2 clinical trial. For additional information about the Company, please visit www.inhibitex.com.
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INX-189 Continues to Shape Up as a Very Potent Nuke
"Y. Katherine Xu - William Blair & Company, L.L.C."
· Before the markets opened on Tuesday, Inhibitex reported data from an additional arm in the Phase Ib study of its lead nuke (nucleotide polymerase inhibitor) candidate INX-189 in combination with ribavirin (R). Viral load drop at 7 days from the INX-189 100 mg QD+R combo was 3.79 logs, versus 2.53 logs for monotherapy INX-189 at 100 mg QD, demonstrating again the synergy between the two compounds, as R usually could contribute 0.5 log drop on its own. Earlier data from the Phase Ib study demonstrated dose-dependent additive/synergistic antiviral activity with 9 mg and 25 mg QD doses of INX-189 in combination with R; at the current dose of 100 mg, the synergy appears to be stronger. We summarize the 7-day viral kinetic activity from the Phase Ib study to date in table 1. In addition, the combination was determined to be safe and well tolerated, with no serious adverse events (SAEs).
· Further expansion of Phase Ib study to climb up the dose on monotherapy as well as combo therapy with R, as expected. Inhibitex plans to amend the ongoing Phase Ib study to include three additional 7-day treatment cohorts 1) INX-189 200 mg QD+R; 2) monotherapy INX-189 300 mg QD; and 3) monotherapy INX-005 (single isomer of INX-189) 200 mg QD.
· The monotherapy potency and the synergy with R demonstrated to date are encouraging; looking to match up PSI-7977 of Pharmasset and Gilead. As summarized in table 1, so far INX-189 monotherapy at 200 mg QD monotherapy produced 4.25 log drop, and 100 mg QD+R produced 3.79 log. Going forward, the 300 mg QD monotherapy and the 200 mg QD+R combo could produce higher viral load drops, approaching the 4.7 log drop demonstrated by Pharmasset's PSI-7977. We note that a potent nuke in combination with R, as demonstrated by Pharmasset, could become a stand-alone therapy.
· Expansion of the ongoing Phase IIb study by adding interferon-free, INX-189+R arms, following Pharmasset's footstep. Initiated in September 2011, the ongoing 12-week Phase IIb study planned to enroll and randomize 90 treatment-naïve GT2/3 into four cohorts 1) INX-189 25 mg QD +P/R (PEG-interferon+ribavirin) (n=25); 2) INX-189 50 mg QD + P/R (n=25); 3) INX-189 100 mg QD + P/R (n=25); or 4) placebo+P/R (n=15). Inhibitex will submit a protocol amendment by year end to include two additional interferon-free cohorts to the study: 1) 100 mg QD +R and 2) 200 mg QD +R. Completion of enrollment of the first four cohorts is expected by year end, and preliminary rapid virologic response (RVR) and early virologic response (EVR) data are anticipated by first quarter 2012.
· With such potency demonstrated, safety is now the gating point for INX-189's commercial viability. Should INX-189 demonstrate satisfactory 12-week safety, the probability of INX-189 eventually becoming commercially viable will be dramatically increased, in our opinion. .....We expect 12-week safety data from the first four cohorts of the Phase IIb study in the beginning of second quarter 2012; however, we would not be fully convinced of the safety profile until we see the full 12-week safety data from the planned interferon-free 200 mg QD of INX-189+R cohort. Such data may be available during the second half of 2012.
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Inhibitex jumps as company expands drug testing
Shares of Inhibitex Inc. climbed Tuesday after the company said it plans to expand studies of its experimental hepatitis C drug.
THE SPARK: The Atlanta company said it will ask the Food and Drug Administration for authorization to expand a mid-stage trial of its drug INX-189. Inhibitex wants to test larger doses of the drug and also wants to test a combination of INX-189 and ribavirin, a standard hepatitis C treatment. The regimen would exclude pegylated interferon, also a standard drug used in hepatitis C treatment.
The patients in the trial have genotype 2 or 3 hepatitis C. They are currently getting as much as 100 milligrams of INX-189 per day in the 12-week study. If the new trial design is approved, some patients will get 100 milligrams and 200 milligrams per day.
The company said it sold $20 million in stock to fund expansion of the trial.
Inhibitex also said it will expand a shorter early-stage trial of the drug to include 200-milligram and 300-milligram doses of INX-189. It will test the drug by itself, in combination with ribavirin, and combined with a second drug it is developing.
THE BIG PICTURE: Inhibitex is a development-stage company. It has no products on the market and INX-189 is its most advanced product. The drug is given by mouth and it is considered a promising treatment for hepatitis C. The chronic form of the disease can cause severe liver damage and is the primary cause of liver transplants in the U.S. The disease is expected to become a larger public health problem as baby boomers age.
Several companies are studying hepatitis C treatment regimens that don't include pegylated interferon, a drug that is administered by injection and can cause severe side effects. Inhibitex's decision to test INX-189 without interferon suggests the company thinks INX-189 will also be just as effective without interferon, matching the convenience and lower side effects of other experimental hepatitis C drugs.
SHARE ACTION: Inhibitex stock rose $1.62, or 14.2 percent, to $13.02 in morning trading. Earlier the shares reached an all-time high of $13.94. The stock doubled in value on Nov. 4 after Inhibitex said a 200-milligram dose of INX-189 reduced virus levels in patients during an early clinical trial.
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Inhibitex Soars as Investors Chase Hepatitis Drug Developers
excerpted
http://www.minyanville.com, By Brett Chase Nov 29, 2011 1:20 pm
Gilead's $11 billion planned takeover of Pharmasset is generating investor excitement for rivals. Achillion and Idenix also rising.
The conventional wisdom after Gilead Sciences' (GILD) recently announced $11 billion takeover of hepatitis drug developer Pharmasset (VRUS) is that similar companies will be gobbled up for big prices.
The deal gave a boost to the already rising stocks of three smaller companies developing their own treatments for the liver-wasting virus hepatitis C: Inhibitex (INHX), Achillion Pharmaceuticals (ACHN) and Idenix Pharmaceuticals (IDIX).
But one only need look at the large players in various stages of developing their own hepatitis treatments to find potential suitors. Merck (MRK), for instance, beat Vertex to market with its new hepatitis treatment Victrelis by about a week but that product is being trounced by Incivek. (See Vertex Hepatitis Drug Beats Estimates.) Other big companies studying treatments include Vertex's development partner Johnson & Johnson (JNJ), Bristol-Myers Squibb (BMY), Abbott Laboratories (ABT), Novartis (NVS), Roche and Boehringer Ingelheim.
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