With so many pharmaceutical companies developing and testing new Hepatitis C drug treatments lately, investors may find it difficult to keep up. Idenix Pharmaceuticals (IDIX) recently revealed some promising news concerning clinical trials for one of its new Hepatitis C drug treatments, IDX719. The company released data from a Phase I clinical trial at Cambridge Heathtech Institute's 5th Annual HVC Drug Discovery meeting, held in San Diego, California. Idenix started the Phase I study in January of 2012. This study measured, among other things, patient safety and how food interacted with drug effectiveness.
Idenix stated that forty volunteers took part in the study, out of which, eight were given IDX719. The volunteers reacted well to the drug and even showed signs of virus suspension for about three days. The study provided the company with enough positive data to continue clinical trials of IDX719.
In addition to IDX719, the company also revealed at the HVC Drug Discovery meeting it will start Phase II testing of its other Hepatitis C drug treatment, IDX184, an HCV nucleotide inhibitor. This clinical trial will determine the effects of IDX184 when combined with pegylated interferon and ribavirin (PegIFN/RBV). After completing this study, the company has plans to start a new clinical trial combining IDX719 and IDX184 - this trial should begin at the end of 2012.
One of the reasons behind releasing this data at the drug discovery meeting may have been to quell any rumors that clinical trials have not yielded any positive results for either drug treatment. Recently, the company has been under fire from a variety of analysts including Brian Skorney from Brean Murray Corrat who questioned if longer clinical trials would be needed to ensure the effectiveness of IDX184. Upon hearing this talk from analysts, many investors pulled out of Idenix, which lowered the stock price. But with this new data from the company, investors may decide to come back in full support of its Hepatitis C drug treatments. For now, Idenix continues to perform clinical trials on both drugs to learn as much as possible before applying for FDA approval.
One of the main issues investors face when considering whether or not to stay with companies like Idenix is the competition. With several big name companies developing Hepatitis C drug treatments, it may make more sense to invest elsewhere. On other hand, with positive results from one clinical trial and the start of a Phase II clinical trial, investors should not ignore Idenix either. To truly appreciate which companies have made the most progress in the development of Hepatitis C drugs, investors will have to carefully review all clinical study data to determine the best place to invest.
In a very short time, Hepatitis C treatments have become very popular with investors and analysts. This may be due in part to the numerous companies out there creating and testing possible treatment options, but also because Hepatitis C affects about 3.2 million people in the United States alone. The virus, which moves through the body attacking major organs including the liver, may go undetected for years unless specific tests are conducted. This means that agencies like the Centers for Disease Control (CDC) can only provide an estimate of how many people actually carry the virus. Manufacturing and selling a treatment that would help kill the virus or at least keep it in a dormant state for a prolonged period of time would not only help millions of people, but would also prove very profitable to the company that develops it and to investors as well.
Abbott Laboratories (ABT), a competitor in the Hepatitis C drug treatment market, recently released data from two short studies that showed significant recovery rates in those who participated. Together, the studies showed 95% and 93% 'cure' rates among volunteers taking other Hepatitis C drug treatments and 47% 'cure' rates among those not taking any other drug treatments. Cure rate refers to stopping or slowing the progression of the virus. Damage already done by the virus cannot be treated with these drugs. The company has since started Phase II clinical trials. If all goes well, the company will proceed to Phase III clinical trials and then apply for FDA approval to manufacture and sell the drug treatment.
Gilead Sciences (GILD), another company anxious to get into the Hepatitis C treatment market, has its own drug, GS-7977, which it acquired through the purchase of Pharmasset in late 2011. Gilead, mostly known for its HIV drug treatments, Truvada and Viread, could become major competition for Index and other companies if its drug performs well in upcoming clinical trials. Another reason the company wants to enter this market is that it will lose patents to these medications toward the end of this decade. This means that generic drug companies will be able to manufacture these drugs and sell them for less.
Vertex Pharmaceuticals (VRTX) and Merck (MRK), two other companies developing new drug treatments to Hepatitis C, may also provide ample competition for Idenix. Vertex recently released a sub analysis of data from its Phase II clinical trial of its Hepatitis C drug treatment, Incivek. During a 12-week trial, volunteers who took the drug, combined with pegylated-interferon and ribavirin, showed a 100% 'cure' rate. The company plans to continue Phase II and Phase III testing to make further improvements. Incivek received FDA approval in May 2011.
Medivir (MVIRB) has reported strong results with its drug treatment, TMC435. Working with Johnson & Johnson (JNJ) to develop this drug, the company conducted a trial that resulted in an 80% 'cure' rate in volunteers that took the drug for 48 weeks. Within 24-week post-treatment, the virus disappeared.
With intense competition from a variety of companies, Idenix and others need to continually conduct trials and publish results quickly to satisfy investors. For the medical community, especially those with Hepatitis C, this high level of competition may signal the end of a potentially life-threatening disease. For investors, it could mean big profits for many years to come.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.