VirusInhibitex: Phase II Clinical Trial for ShinglesWikinvest--Inhibitex, Inc. INHX
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Inhibitex, Inc. (NASDAQ: INHX) increased 10% on Friday after announcing completed enrollment in their Phase II clinical trial of FV-100 for shingles. With top-line data expected later this quarter, expect buying pressure to increase in the short term.
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Inhibitex, Inc. was founded in 1994 and focuses on products to prevent and treat serious infectious diseases. The company's pipeline includes INX-189 for the treatment of chronic infections caused by hepatitis C and Aurexis for the treatment of S. aureus bacteremia and related complications in hospitalized patients. Additionally INHX has licensed the use of its proprietary MSCRAMM protein platform to Pfizer for the development of active staphylococcal vaccines.
There are 2.5 million shingles cases worldwide annually and the company estimates 90% will experience associated pain. FV-100 was developed to both treat shingles and reduce associated pain including post-herpetic neuralgia (PHN), which is shingles-associated pain that lasts at least 90 days and occurs in 20% of shingles patients.
As-of June 30th, 2010, the company had over $29M in cash and equivalents, $6.2M in total liabilities, and a quarterly burn rate of approximately $5.2M. This should prove ample liquidity to reach the announcement of top line results without the risk of further dilution. Including warrants we estimate outstanding shares of approximately $74M.
Insiders hold 20% of the outstanding shares with institutions including funds from Fidelity, Franklin, and Vanguard holding an additional 50%. The institution investment is particularly impressive seeing the company's current stock price of $2.01 per share and could help limit the shares available for investment, providing further fuel for advancement in an upward trend.
The stock has a 52 week high of $2.95 and low of $0.67 on a three month average daily volume of 144k shares. Liquidity presents somewhat of an issue, though it may be attributed to 70% of outstanding shares being held by insiders/institutions. Furthermore, volume is expected to increase leading up to top-line results.
With above average institutional interest for a company its size and fairly low retail following, Inhibitex presents a unique investment opportunity. Increased coverage leading up to top-line results should produce additional retail demand and price appreciation. Biotech Bulls has initiated coverage and will continue to analyze the company for entry and exit points leading up to phase II results.
The Phase II trial is a well-controlled, double-blind study of 350 shingles patients, aged 50 years and older with shingles-associated pain, who were randomized equally to one of three treatment arms: 200 mg or 400 mg FV-100 administered orally once daily, or 1,000 mg valacyclovir administered orally three times per day. The Company anticipates top-line data from the trial will be available later this quarter.
About Shingles and FV-100
Shingles is an infection caused by the reactivation of varicella zoster virus (VZV), the same virus that causes chicken pox. Worldwide, it is estimated that more than 2.5 million new cases of shingles occur each year, and that one in four adults will suffer from shingles during their lifetime. While shingles can develop in adolescents or adults of any age, it occurs predominantly in individuals 40 years of age and older. Shingles is generally characterized by skin lesions or rash, acute infection-related pain, and in many cases, PHN, which is a painful and often debilitating chronic complication that impacts approximately one out of every five shingles patients. PHN can last for months or possibly years, and has been shown to have a measurable and significant impact on patients' quality of life and functional status.
Published in vitro studies have demonstrated that FV-100, an orally available bicyclic nucleoside analogue, is significantly more potent against VZV, and can inhibit its replication substantially faster than any other antiviral agent currently approved for the treatment of shingles. The Company believes these characteristics, plus a favorable pharmacokinetic profile, support the potential of FV-100 as a highly potent, once-daily oral therapy to reduce the incidence, severity and duration of shingles-related symptoms, including acute pain and PHN.
The Phase II trial is a well-controlled, double-blind study of 350 shingles patients, aged 50 years and older with shingles-associated pain, who were randomized equally to one of three treatment arms: 200 mg or 400 mg FV-100 administered orally once daily, or 1,000 mg valacyclovir administered orally three times per day. The Company anticipates top-line data from the trial will be available later this quarter.
Inhibitex Successfully Completes Phase 1a Trial of INX-189
Posted on: Wednesday, September 1, 2010
ATLANTA--(BUSINESS WIRE)--
Inhibitex, Inc. (Nasdaq: INHX), announced today that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting. Preliminary data from the trial are as follows:
•INX-189 was generally well tolerated at all dose levels;
•No drug-related serious adverse events;
•No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache and nasal congestion;
•No grade II or higher laboratory abnormality adverse events or clinically significant changes in ECGs; and
•Pharmacokinetic data supports INX-189’s potential for once daily (QD) dosing.
“We are encouraged with the initial safety and pharmacokinetic profile of INX-189 in this first-in-man trial,” stated Dr. Joseph Patti, Senior Vice President and Chief Scientific Officer of Inhibitex, Inc. “Based upon the pharmacokinetics observed in this study, we continue to believe that INX-189 has the potential to demonstrate antiviral activity with a low once-daily dose, and we look forward to assessing its ability to reduce HCV RNA viral loads in patients with chronic hepatitis C in a Phase 1b multiple ascending dose trial we plan to start in the fourth quarter.”
Inhibitex Ready for Big 2nd Half - Analyst Blog
Posted on: Tuesday, August 10, 2010
Smooth Sailing For FV-100
It’s been smooth sailing so far for Inhibitex (INHX) in the phase II program on FV-100. Since initiated in May 2009, the independent data safety monitoring board (DSMB) responsible for reviewing safety data from the trial has met three times to review 30-day follow-up safety data from the first, second and third quartiles. After each time, most recently as of July 22, 2010, the DSMB recommended the trial continue as planned.
We expect that enrollment at 350 patients should complete in the third quarter 2010, with top-line data to become available in the fourth quarter 2010. Back in April 2010, an independent statistician conducted a prospectively described interim analysis of the primary efficacy endpoint on the first half of the patients enrolled in the trial and recommended that the trial continue to completion as designed.
As a reminder, the phase II program, initiated in May 2009, is a well-controlled, double-blind, clinical trial evaluating FV-100 against an active control of Glaxo’s Valtrex (valacyclovir). Roughly 350 patients, aged 50 years and older, will be randomized to one of three treatment arms: 200 mg FV-100 administered once daily; 400 mg FV-100 administered once daily; and 1,000 mg valacyclovir administered three times per day. The primary endpoint of the trial is a reduction in herpes zoster associated pain and severity as measured by the Zoster Brief Pain Inventory (ZBPI) scale after 30 days of treatment.
The trial is 80% powered to detect an approximate 25% difference between the FV-100 and Valtrex cohorts. In addition to the primary endpoint, Inhibitex will also report: 1) reduction in ZBPI after 90 days, 2) incidence of post herpetic neuralgia (PHN), 3) mean time to lesion healing, and 4) use of concomitant pain medications. We are optimistic on the outcome of this trial and believe it presents management with a significant partnering opportunity in 2011.
The next step for management following completion of the phase II trial would be to schedule an End-of-Phase II meeting with the U.S. FDA in 2011. We expect that Inhibitex will look to push FV-100 into a pivotal phase III program shortly thereafter. Our best guess is that the phase III program will include two concurrent programs, with a total enrollment of around 1000 patients, and take an estimated two years to complete.
Therefore, if all goes well, we could be looking at a new drug application (NDA) on FV-100 around 2014, with U.S. FDA action in 2015. We note that management has mentioned being in discussion with potential partners on FV-100, and we fully expect a deal in 2011. However, at this point it remains to be seen whether or not a deal is signed prior to the initiation of a phase III program. We note the longer management waits to partner FV-100, potentially the better economics management can negotiate for shareholders.
INX-189 Phase I Underway
Management is progressing in a phase Ia single ascending dose study to evaluate the safety and pharmacokinetics of INX-189, the company’s nucleoside polymerase inhibitor under development for the treatment of chronic hepatitis C caused by the hepatitis C virus (HCV). The phase Ia trial will employ up to six escalating doses of INX-189, ranging from 3 mg up to 200 mg. Each dose cohort will include eight subjects, six of which will receive INX-189 and two that will receive placebo, for a total of 48 subjects. There will also be a food-effect study in one of the dose cohorts. We expect that this program will complete in the third quarter 2010.
Pending a successful completion of the above phase Ia program, we anticipate that management will seek to initiate a phase Ib multiple ascending dose, three day monotherapy study in genotype 1 naive HCV infected patients shortly after the top-line data has been released from the phase Ia program. On the second quarter conference call management noted that this program will probably study 4 or 5 doses, with 10 patients in each cohort, for a total of 50 to 60 subjects.
This trial should begin early fourth quarter of 2010, with top-line data from one or more cohorts potentially available before the end of the year. Full data from the phase Ib should become available in the first quarter of 2011.
Inhibitex has also initiated 28 day animal toxicology studies of INX-189 and plans to conduct longer-term toxicology studies, beginning shortly. Assuming successful completion of these chronic toxicology studies and favorable data from both the phase Ia and Ib trial, management should be in position to advance INX-189 in a phase II, 12+ week clinical trial in combination with standard of care and other complementary direct antiviral compounds in 2011. We expect that management will partner the candidate for the phase II program in 2011 assuming safety and proof-of-concept have been effectively demonstrated.
Preclinical data suggests that INX-189 has unrivaled potency in genotype 1 replicon assay. We believe that INX-189 is the most potent nucleotide polymerase inhibitor (“protide”) in clinical development. The preclinical profile of INX-189 suggests: rapid onset of anti-viral activity, a long half-life that could allow for once daily dosing, low toxicity, and a potential synergistic mechanism with ribavirin.
We believe this protide approach possesses several pharmacological advantages over earlier, first generation approaches that use the parent nucleoside (non-phosphorylated) alone. These include a significant increase in antiviral activity, higher concentrations of the anti-virally active triphosphate in liver, and potentially less toxicity due to reduced systemic exposure. This is certainly something to be excited about.
Cash Position OK
Inhibitex exited the second quarter 2010 with $29.3 million in cash and investments. This should be enough to fund operations, including completing the ongoing phase II FV-100 program and completing a phase Ia and phase Ib program on INX-189 in 2011.
We estimate that the company will still have roughly $18 million in cash on hand at the end of the year. Therefore, Inhibitex may be in need of cash at some point in 2011. However, with the potential to partner both FV-100 and INX-189, we believe there is significant opportunity to raise non-dilutive cash in 2011. If management does choose to raise cash through a secondary offering, we do not expect anything before the release of data on FV-100, and we do not expect it to be greater than a 20% dilution.
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