There's one surefire way to tell that a company thinks a drug is doing well in mid-stage clinical trials: It changes its name from something generic -- a number, perhaps preceded by a letter or two -- to a trademarked name.
Developmental-stage drugmaker Anesiva
The trial was designed to test efficacy in patients with moderate to severe osteoarthritis of the knee. Adlea caused a 61% reduction in mean pain intensity from the pre-injection baseline after one week. More importantly -- because who wants to go to the doctor to get a shot every week? -- the pain reduction was sustained for 12 weeks after the injection: 42% of patients reported "no pain," 44% had "mild pain," and only 14% reported "moderate" or "severe" pain.
Anesiva plans to start a phase 2/3 trial for osteoarthritis later in the summer. It will be key to see how the drug compares to placebo in a blinded study. Drugs that treat pain are often susceptible to the placebo effect, since pain is hard to measure and relative to the patient's past experiences.
Adlea previously demonstrated positive results in a phase 2 clinical trial treating patients who underwent a total knee replacement surgery. Anesiva plans to initiate a phase 3 trial testing Adlea for post-surgical pain later in the year. Since there are far more post-surgical patients than those with severe osteoarthritis, this trial will be much more important for Anesiva than getting the drug approved for osteoarthritis.
Assuming it can demonstrate effectiveness in late-stage clinical trials, Adlea should be able to compete well in the pain reduction market. Opioid-based pain medications like DepoDur, from SkyePharma
Anesiva's most advanced drug, Zingo, is awaiting an FDA approval decision in the fall. The future of Anesiva is dependent on that decision, since the company is running out of money. Anesiva estimates that its burn rate for 2007 will be between $55 million and $65 million, leaving it only $30 million to $35 million in the bank at the end of the year. The Adlea results are very promising, but investors should look at the state of the entire company before investing. Without an FDA approval of Zingo or an influx of cash from another source, Anesiva won't have enough money to get Adlea through late-stage clinical trials.
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Fool contributor Brian Orelli, Ph.D., just took two ibuprofen, since he ran a little farther than he should have last night. He doesn't own shares of any company mentioned in this article. The Fool's disclosure policy isn't all that painful to read.
