New Hepatitis C Drug (NM283) Clinical Trial Report
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This is a report on yet another new drug for the treatment of Hepatitis C. The exciting news for most patients in the US, Europe and Japan is that this drug is specifically targeted toward genotype 1. Genotype 1 is the most common genotype in these areas and is also the hardest to treat with current therapy.
Pharmaceutical companies are rushing to develop new and better treatments for Hepatitis C because they see huge profits. They know that current therapy is inadequate or inappropriate for most patients in the US, Europe and Japan. Ultimately, the greed of the pharma companies works to our benefit.
Incidentally, the results of this trial are apparently very good.
Press Release Source: Idenix Pharmaceuticals, Inc.
Idenix Reports Interim Analysis of a Phase IIa Clinical Trial of Valopicitabine (NM283) in Combination with Pegylated Interferon in Treatment-Naive Hepatitis C Genotype 1 Patients
Monday January 10, 8:30 am ET
Patients receiving the combination treatment achieved a mean viral load reduction of 3.2 log10, or 99.94 percent, after 12 weeks of treatment
SAN FRANCISCO, Calif., Jan. 10 /PRNewswire-FirstCall/ — Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX – News), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, today announced interim clinical trial data for valopicitabine (NM283), the company’s lead drug candidate for the treatment of hepatitis C.
In this phase IIa trial, patients are randomized to one of two treatment arms, valopicitabine (NM283) monotherapy, or valopicitabine (NM283) plus pegylated interferon. This interim data analysis includes all 19 patients who have completed 12 weeks of treatment in this trial. The patients receiving the combination of NM283 and pegylated interferon achieved a mean reduction of serum HCV RNA of 3.2 log10, or 99.94 percent, at week 12.
These data will be included in the company’s presentation at the JPMorgan Healthcare Conference on Wednesday, January 12, 2005 at 8:30 a.m. in San Francisco.
“In patients infected with HCV genotype 1 — a difficult-to-treat strain of hepatitis C virus and the most prevalent strain in the U.S., Western Europe and Japan — virologic response to the current standard therapy of ribavirin and interferon is inconsistent,” commented Nathaniel Brown, M.D., Idenix’s executive vice president, clinical development and chief medical officer. “However, the consistency of response to the combination of valopicitabine and interferon appears promising: eleven of twelve patients receiving this combination treatment had significant HCV RNA reductions of 1.7 to 6.2 log10 by week 12.
Based on these encouraging interim data, we have extended this phase IIa trial to 6 months in order to investigate longer duration treatment.” Phase IIa Trial Design and 12 Week Interim Results: Idenix will enroll a total of 30 patients in the phase IIa clinical trial, which is designed to assess the safety, antiviral activity and pharmacokinetics of the combination of NM283 and pegylated interferon compared to NM283 alone.
Key entry criteria for this clinical trial include treatment-naive patients with HCV genotype 1, baseline viral load greater than 5 log10 copies/ml and alanine aminotransferase (ALT) levels less than 5 times the upper limit of normal.
In this phase IIa clinical trial, patients are being randomized to one of two treatment arms so that 12 patients will receive NM283 monotherapy and 18 patients will receive NM283 plus pegylated interferon. After 12 weeks of treatment, mean HCV RNA reductions from baseline were 0.9 log10 IU/mL, or 87.4 percent, for the 7 patients in the NM283 monotherapy group, and 3.2 log10 IU/mL, or 99.94 percent, for the 12 patients in the combination treatment group. Nine of twelve patients receiving combination treatment have achieved an early viral response with a greater than 2 log10 decrease in levels of HCV RNA at week 12.
Tolerance of both treatment regimens has been satisfactory to date, with no serious adverse events. Four- week data from these same 19 patients were presented by Dr. Nezam Afdhal at the American Association for the Study of Liver Diseases’ annual meeting in November 2004.
Hepatitis C Development Program
Idenix’s hepatitis C development program is initially seeking to address the large patient population that has failed to respond to the current standard treatment, pegylated interferon plus ribavirin, and for whom no other treatment option is currently available. Idenix expects to subsequently target the treatment-naive patient population for whom treatment with the current standard of care is only successful in approximately 50% of patients.
“Hepatitis C patients confront many unmet treatment needs, with several hundred thousand having failed prior treatment with no therapeutic options, and millions of people infected with difficult to treat strains of HCV,” said Jean-Pierre Sommadossi, Ph.D., Idenix’s chairman and chief executive officer. “Idenix is committed to rapidly advancing the NM283 clinical program, which seeks to address the medical needs of all individuals infected with hepatitis C.”
Development for Treatment-failure Patients: Idenix has initiated a phase IIb clinical trial for NM283 in patients who have previously failed treatment with pegylated-interferon and ribavirin and expects to begin enrolling patients in this study in early 2005. The company anticipates that this 6- month head-to-head trial, comparing the combination of NM283 plus pegylated interferon to the current standard therapy (ribavirin plus pegylated interferon), will enroll approximately 170 HCV genotype 1 patients who have previously failed at least 3 months of treatment with current standard therapy.
This phase IIb clinical trial will also include a monotherapy arm of NM283. Development for Treatment-naive Patients: Encouraging results from the ongoing phase IIa clinical trial, summarized above, will support initiation of a larger phase IIb clinical trial of valopicitabine (NM283) in combination with pegylated interferon in treatment-naove patients, the majority of whom are expected to be infected with HCV genotype 1. Idenix anticipates beginning this trial in mid-2005.
About Valopicitabine (NM283)
Valopicitabine (NM283) is an oral, novel nucleoside analog that was co- discovered by Idenix and the University of Cagliari through a cooperative laboratory agreement under the direction of Dr. Paolo LaColla, Director of the Department of Biomedical Sciences and Technologies of the University. Valopicitabine (NM283) is being developed in combination with pegylated interferon. To date, valopicitabine (NM283) has demonstrated a satisfactory safety profile with mild to moderate gastrointestinal side effects and no treatment-related discontinuations.
About Hepatitis C
There are approximately 170 million people worldwide with chronic HCV infection, of which approximately 2.7 million are in the United States. Chronic HCV infection accounts for 40 percent of end-stage cirrhosis, 60 percent of liver cancer and 30 to 40 percent of liver transplants in the United States and other industrialized countries. Responses to current treatment options are frequently inadequate due to the inability of some patients to tolerate these treatments and by their limited effectiveness, particularly in patients infected with HCV genotype 1.
The genotype 1 strain of HCV is the most treatment-resistant HCV genotype and is estimated to cause more than 70 percent of the reported cases of hepatitis C in the U.S. and Japan, and more than 65% of the reported cases of hepatitis C in Western Europe.
About Idenix
Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix’s current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV).
Idenix’s headquarters are located in Cambridge, Massachusetts and it has drug discovery operations in Montpellier, France and Cagliari, Italy. For further information about Idenix, please refer to http://www.idenix.com.
Forward-looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Act of 1995. Statements in this press release other than those that are historical in nature are “forward- looking statements.”
Such forward looking statements, which include statements with respect to the potential therapeutic benefits and successful development of the company’s drug candidates and the company’s drug discovery, research and clinical development activities, are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. These risks and uncertainties relate to the results of clinical trials and other studies with respect to the drug candidates that the company has under development; the timing and success of submission, acceptance and approval of regulatory filings; the company’s dependence on its collaboration with Novartis Pharma AG; the company’s ability to obtain additional funding required to conduct its research, development and commercialization activities; the ability of the company to attract and retain qualified personnel, and the company’s ability to obtain, maintain and enforce patent and other intellectual property protection for its drug candidates and its discoveries.
These and other risks are described in greater detail in the “Risk Factors” section of the company’s quarterly report on Form 10-Q for the quarter ended September 30, 2004 and filed with the Securities and Exchange Commission and other filings that the company makes with the Securities and Exchange Commission.
All forward-looking statements reflect the company’s expectations only as of the date of this release and should not be relied upon as reflecting the company’s views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
