• Amarin Corp. plc, of Dublin, Ireland, said results from its pivotal Phase III trial (ANCHOR) are now available electronically through The American Journal of Cardiology, scheduled for print publication in October 2012. The publication describes previously reported results showing that the product, AMR101, met all primary and secondary endpoints. The 12-week, placebo-controlled, randomized, double-blind, 12-week study evaluated AMR101 for high triglycerides in patients with mixed dyslipidemia.

• BioCryst Pharmaceuticals Inc., of Research Triangle Park, N.C., reported favorable 52-week safety results and sustained efficacy from the extension phase of its randomized Phase IIb trial of ulodesine (BCX4208) added to allopurinol in patients with gout who had failed to reach the serum uric acid therapeutic goal of < 6 mg/dL on allopurinol alone, as well as positive Phase II safety results in mild to moderate renal impairment. The company said it was preparing materials and protocols for Phase III trials and seeking a partner to initiate the pivotal program. (See BioWorld Today, Oct. 6, 2011.)

• Debiopharm Group, of Lausanne, Switzerland, said the first patient was treated in a multicenter, open, noncomparative Phase III study investigating the safety, efficacy and pharmacokinetics of two subcutaneous injections of Debio 8206 (triptorelin pamoate) in advanced prostate cancer. The study, conducted in the Republic of South Africa, will include 120 patients suffering mainly from advanced prostate cancer. Patients with recurrent lower-stage prostate cancer and rising prostate-specific antigen following local therapy failure who are candidates for androgen deprivation therapy also will participate. Patient evaluation will be based primarily on efficacy in achieving castrate levels of testosterone 28 days after the first injection of Debio 8206 and in maintaining castrate levels of testosterone from Day 57 to Day 337. The safety profile also will be evaluated. The compound's six-month formulation is currently commercialized for intramuscular administration in several countries.

• Eisai Europe Ltd., of Hatfield, UK, part of Eisai Inc., presented the first clinical data for E2609, a beta-site amyloid precursor protein-cleaving enzyme (BACE) inhibitor, during oral sessions at the Alzheimer's Association International Conference 2012 in Vancouver, British Columbia. Two Phase I studies presented at the conference included a single oral ascending dose study, A001-001, which showed a reduction in plasma amyloid beta levels, and A001-002, a 14-day multiple oral ascending dose study that showed a statistically significant reduction of cerebrospinal fluid amyloid beta levels. Both studies showed a dose-related increase in plasma drug exposure. Eisai said the Phase I findings confirmed E2609's proof of mechanism for preventing amyloid beta production by BACE inhibition in humans.

• Nektar Therapeutics Inc., of San Francisco, reported that the first patient has been enrolled in a Phase II study of its opioid analgesic candidate NKTR-181. The mu-opioid agonist molecule is designed to have a slow rate of entry into the brain to reduce its attractiveness as a target of abuse and to reduce other CNS-mediated side effects, such as sedation and respiratory depression. The study will use a double-blind, placebo-controlled, randomized withdrawal study design to assess the efficacy, safety and tolerability of NKTR-181 in opioid-naive patients with moderate to severe chronic pain from osteoarthritis of the knee. Approximately 200 patients will be enrolled in the trial The company said that is also planning a separate human abuse liability study for NKTR-181 as part of the Phase II development for the compound.

• Ocular Therapeutix Inc., of Bedford, Mass., reported initial results of its sustained-release travoprost-loaded punctum plug (OTX-TP1) feasibility study in glaucoma. OTX-TP1 was evaluated to reduce elevated intraocular pressure in open-angle glaucoma or ocular hypertension over a 30-day period. Twenty six eyes in 17 patients were treated at the Singapore National Eye Center and the National University Hospital in Singapore. Prior to inserting the plugs, mean intraocular pressure at baseline for the study group was recorded at 26.3 mm Hg. Intraocular pressure (IOP) decreased by 5.5 mm Hg three days following insertion and mean IOP was 6.5 mm Hg below baseline after 30 days of treatment. OTX-TP1 is designed to absorb in approximately four to six weeks, and 88 percent of plugs were present at 30 days. The company said results were comparable to those of topical ophthalmic solutions Travatan (travoprost, Alcon Inc.), Lumigan (bimatoprost, Allergan Inc.) and Xalatan (latanoprost, Pfizer Inc.), without the compliance issues associated with daily dosing.

• Psyadon Pharmaceuticals Inc., of Germantown, Md., stopped a Phase II trial of ecopipam in patients with Tourette syndrome when a planned interim analysis showed a statistically significant reduction in the severity of tic symptoms, a decision supported by the independent drug safety and monitoring committee and the research committee formed through Psyadon's partnership with the Tourette Syndrome Association. The open-label, nonrandomized study evaluated ecopipam over an eight-week period at 50 mg per day for two weeks, and 100 mg per day for the remaining six weeks. Its primary efficacy endpoint was change in Yale Global Tic Severity Score. It had 15 subjects at the time of interim analysis. Psyadon plans to move the drug to the next stages of development.

• XenoPort Inc., of Santa Clara, Calif., said the first subjects were dosed in a randomized, double-blind, two-period crossover, food effect Phase I comparison study of XP23829 in healthy adults. The trial is designed to assess the pharmacokinetics, safety and tolerability of a single dose of XP23829, a fumarate analogue for the potential treatment of relapsing-remitting multiple sclerosis and psoriasis, under both fasted and fed conditions. The trial will assess the blood levels of XP23829, its active metabolite, monomethyl fumarate, and other potential metabolites. An immediate-release formulation and three extended-release formulations will be studied as candidates for once-daily dosing.