Anesiva Announces Phase 2 Data Showing Substantial, Long-Term PainReductions with Adlea(TM) (formerly 4975) in Osteoarthritis of theKnee- Pain Reductions Observed at Eight Weeks Sustained up to 12 Weeks and Drug Remains Very Well Tolerated -
SOUTH SAN FRANCISCO, Calif., July 02, 2007 /PRNewswire-FirstCall/ -- Anesiva, Inc. today announced preliminary longer-term, follow-up results from a Phase 2 study showing that a 1mg treatment with Adlea(TM) (formerly 4975) in patients with moderate-to-severe osteoarthritis of the knee produced substantial reductions in pain that persisted for up to 12 weeks.
"The positive preliminary results from this knee pain study further strengthen our belief that Adlea will prove to be a safe and effective drug in multiple osteoarthritis indications," said John P. McLaughlin, chief executive officer of Anesiva. "We are on-track to advance Adlea into late-stage trials in various indications this summer, including a Phase 2/3 trial for osteoarthritis of the knee."
Fifty-five patients with osteoarthritis of the knee were randomized to receive either: (I) a single injection of 1 mg of Adlea (n=36) or (II) three stepped ascending weekly doses totaling 1 mg of Adlea (n=19). At baseline prior to treatment, approximately three quarters of the patients had moderate pain while the other quarter had severe or extreme pain. As was previously reported, patients treated with Adlea demonstrated a 61 percent reduction in mean pain intensity from baseline to week one, and the analgesic effect was sustained at all subsequent weeks to the last scheduled in-clinic assessment at week eight, at which time a 64 percent reduction in pain from baseline was reported. At week 12, pain reductions were sustained. A cohort of 50 patients showed a 65 percent reduction from baseline pain scores. Forty two percent of the patients reported "no pain," 44 percent had "mild pain," and only 14 percent reported "moderate" or "severe" pain. The lengthy duration of clinical benefit is consistent with the known mechanism of action that suggests treatment with Adlea administered as a single injection or stepped doses leads to pain relief durable for 12 weeks in patients suffering from moderate to severe pain due to knee osteoarthritis.
The following table summarizes the reduction in pain scores provided by the use of Adlea compared to baseline pain scores. A scale of 0-4 (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain and 4 = extreme pain) was used in the study:
-- Weeks Following Adlea Treatment -- Baseline 1 8 12 (n=54) (n=51) (n=54) (n=50) Average Pain Score 2.22 0.86 0.79 0.74 Percentage Reduction from Baseline N.A. 61% 64% 65%
How Adlea May Address Need for Long-Duration, Well-Tolerated Pain Relief
Adlea is long-acting, with the potential to provide pain relief for weeks or months after just a single localized treatment. It is a non-opioid TRPV1 agonist with a unique mechanism of action that provides a long-lasting, localized effect on C-fibers and blocks the transmission of aching, throbbing pain caused by major surgical procedures and end-stage osteoarthritis. Because it selectively acts on pain-sensing nerve endings, Adlea does not affect other nerve fibers necessary for sensory or motor sensations, such as those needed to sense temperature or pressure. In clinical studies to date, Adlea has not had the side effects often associated with other conventional pain medications and has been shown to be well tolerated.
Pharmacokinetic studies of Adlea showed that when it is locally administered to the site of pain, there appears to be limited systemic exposure. Its short duration of systemic exposure (hours) relative to the long duration of analgesia (12 weeks) resulting from a single treatment course of Adlea is particularly important in this typically elderly and vulnerable patient population and may potentially offer a safer treatment option in the management of chronic osteoarthritis pain. Importantly, the prolonged analgesic effect resulting from a single or stepped dose, localized administration of Adlea does not seem to be associated with the systemic side effects commonly associated with NSAIDs (gastrointestinal and renal toxicities, and impaired clotting), COX-2 inhibitors (cardiovascular risks and renal toxicity), or opioids (respiratory depression, nausea/vomiting, sedation, disorientation, physical dependence, and the risk of addiction).
About Osteoarthritis of the Knee
Osteoarthritis of the knee is a common, progressive disease in which the joint cartilage breaks down. This breakdown causes the bones to rub against each other resulting in stiffness, pain, and loss of movement in the joint. In advanced stages, the pain becomes intractable and disabling, limiting patients' mobility and activities. At least five million patients in the U.S. are suffering from moderate to severe osteoarthritis of the knee and are candidates for knee replacement or aggressive non-surgical interventions to address the debilitating effects of end-stage osteoarthritis of the knee.
About Anesiva and its Diverse Pipeline of Pain Products
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has two drug candidates in development for multiple pain-related indications. A New Drug Application (NDA) has been filed for the most advanced product, Zingo(TM). The second product in the pipeline, Adlea (formerly 4975), has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, moderate-to-severe pain. Anesiva is based in South San Francisco, CA.
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: the timing and outcome of our clinical trials and the results of the regulatory approval process for our product candidates. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's Form 10-K for the year ended December 31, 2006.
Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
Posted: July 2007