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Anacor Pharmaceuticals has announced positive results from a phase I study of AN2690 for the treatment of onychomycosis. This trial enrolled 15 subjects who had at least 8 infected nails. Subjects were administered a 7.5% solution of AN2690, topically, for 28 days. Pharmacokinetic data demonstrated a positive absorption rate; blood samples taken at days 1, 14 and 28 did not reveal quantifiable levels of the drug in the bloodstream. Additionally, 14 days post-treatment, concentrations of AN2690 in the nail plate remained at therapeutic levels. Preliminary efficacy data were positive; all nail cultures taken at the end of the treatment cycle tested negative for fungal infection. Anacor is currently investigating AN2690 in three phase II studies.
Emergent BioSolutions reported positive results of a phase II trial of their investigational oral typhoid vaccine, for the prevention of Salmonella typhi infections. Trial data indicated that a simple rapid dosing regimen did not negatively impact safety or immunogenicity levels, compared to an earlier regimen which required preloading with a bicarbonate buffer and a restricted reconstitution process. Both formulations were highly immunogenic, producing response deemed appropriate for clinical and commercial use. This open-label study enrolled 32 healthy subjects, who received single oral doses of either the older lyophilized formulation or Emergent's investigational vaccine. Following these results, the company announced plans to conduct additional phase II trials of the drug in Vietnam, prior to initiating phase III development.
NexMed has issued positive results of a phase I trial of their investigational antifungal nail lacquer NM100060 (NexACT terbinafine), for the treatment of onychomycosis (nail fungal infections). Pharmacokinetic data indicated that lacquer application of the drug produced peak plasma concentrations approximately 2500% less that a single oral dose of terbinafine, and comparable levels to an approved terbinafine cream. Target drug concentrations in nail clippings were achieved by mid-way through the treatment period. Safety data yielded no reported serious adverse events; the most common overall adverse event was minor local irritation. This double-blind, randomized, parallel-design, placebo controlled study enrolled 56 patients, who received treatment with NM100060, an approved 1% terbinafine cream, and and a single 250 mg terbinafine oral tablet. The company announced that they had initiated licensing discussions for the drug.
Vicuron Pharmaceuticals reported positive results of a phase III trial of anidulafungin, for the treatment of hospital acquired candidiasis/candidemia. Study data exceeded their primary endpoint of non-inferiority, establishing statistically superior global response in the intent-to-treat population vs. standard therapy with fluconazole at the end of treatment (75.6%, n=96/127 vs. 60.2%, n=71/118; p<0.05). Secondary endpoints were also met, with superiority established in global response at 2 week follow-up (64.6%, n=82/127, vs. 49.2%, n=58/118), and non-inferiority established in global response at 6 week follow-up (55.9%, n=71/127, vs. 44.1%, n=52/118). This randomized, double-blind, multi-center study enrolled 256 subjects with invasive candidiasis/candidemia, who received daily doses of either 100 mg anidulafungin or 400 mg fluconazole for 10-42 days. Based on these results, the company announced plans to amend their pending NDA for esophageal candidiasis in Q2 2005, and file an NDA for the drug for invasive candidiasis/candidemia in Q3 2005.
Barrier Therapeutics also reported preliminary results of a phase IIa trial of Rambazole, for the treatment of psoriasis. Data from the first 10 patients completing treatment indicated that drug was efficacious in treating psoriasis, producing a mean reduction of 50% in PSAI score (a standardized symptom-severity scale) after 8 weeks of treatment, compared to baseline. The drug was safe and well tolerated in these patients, with mild dryness of the skin and lips reported most often. This ongoing, open-label study has a projected total enrollment of 17 subjects. Assuming final data confirm these interim results, Barrier announced plans to initiate a phase IIb trial of Rambazole by the end of Q2, 2005.
Barrier Therapeutics reported positive data from a phase IIa study of Azoline, for the treatment of superficial dermal fungal infections. Results from the trial demonstrated preliminary evidence of efficacy, with 60% response rates for subjects receiving 1 day of treatment and 78-100% response for subjects receiving either 3 or 5 days of treatment, depending of the nature of the skin condition. In addition, the drug demonstrated a positive safety and tolerability profile, with no serious treatment-related adverse events noted. This open-label study enrolled a total of 67 subjects, who were randomized to receive 200 mg. Azoline once daily for 1,3, or 5 days. Based on these results, Barrier announced plans to initiate phase IIb trials of Azoline in the second half of 2005.
Boehringer-Ingelheim has reported positive results of a phase III trial of tipranavir, their investigational protease inhibitor for the treatment of HIV infections. Results from a 24-week interim analysis have indicate that the drug is efficacious in reducing viral load, with a significantly greater portion of subjects receiving tipranavir plus low-dose ritonavir (T/r) achieving treatment response (a 1 log(10) or greater decrease) than in those receiving a comparator protease inhibitor plus low-dose ritonavir (CPI/r) (41.0% vs. 14.9%; p<0.001). Furthermore, subjects receiving T/r experienced a significantly greater portion of subjects achieving preset total viral load levels of 400 copies/ml and 50 copies/ml (p<0.0001), and significant greater increases in CD4+ count (p=0.02), than in subjects taking CPI/r. The randomized, approved-therapy controlled, open-label trial was designed to study the safety and efficacy of T/r versus CPI/r, in 863 treatment-experienced patients with documented protease-inhibitor resistance. This trial, along with a second phase III study, formed the basis of the company’s NDA application, submitted on October 22, 2004.<
MacroChem has announced positive results of a phase I trial of EcoNail (SEPA plus econazole), an investigational antifungal lacquer for the treatment of onychomycosis, a common fungal infection of the nail. Trial data indicate that the study met its primary safety and pharmacokinetic endpoints, with no serious drug-related adverse events and no detectable systemic absorption. The randomized, double-blind, placebo controlled trial enrolled 18 patients suffering from onychomycosis across 2 clinical sites in the US. Subjects received twice daily applications of either EcoNail or placebo lacquer 6 weeks, and were monitored for adverse events and systemic absorption. An ongoing open-label extension is currently underway, with all patients receiving EcoNail once daily to all nails for an additional 12 weeks, and MacroChem announced plans to initiate a preliminary efficacy trial in early 2005.
PowderMed has issued results of their first phase I trial of their DNA influenza vaccine candidate. Results indicate that the trial met its primary endpoints, with all trial doses of the drug being well tolerated and a significant number of subjects exhibiting immune response sufficient to meet standards established for European approval after 56 days. Furthermore, the highest dose of the drug met the criteria after just 21 days, and 100% of subjects receiving this dose achieved seroprotective antibody levels. This open-label trial enrolled 36 healthy adult volunteers, who were randomized to receive one of three single doses of the vaccine (1, 2 and 4 micrograms), followed by a 56 day follow-up observation.
The Immune Response Corporation presented data from their ongoing phase II study of Remune, their investigational antiretroviral vaccine for the treatment of HIV, at the 7th International Congress on Drug Therapy in HIV Infection in Glasgow, Scotland. Preliminary results from the 37 subjects having thus far received treatment demonstrate positive trends in several immune-response indicators, including stabilization of total CD4+ T-cell counts, increased HIV-specific CD8+ memory T-cells, and decreased levels of activated CD38+ T-cells, following treatment. This multi-center, single-blind study has to date randomized 37 of a projected 51 treatment naïve HIV-positive subjects to receive one of two treatment regimens of Remune (one injection Remune & two placebo or three injections Remune), or Incomplete Freund's Adjuvant (a non-targeted immunostimulatory) or placebo over 28 weeks; the four arms of the study each received injections at trial initiation and weeks 12 and 24. Immune Response, following these results, has announced plans for a rollover study which will include treatment with both Remune and IR103, another of the company’s investigational antiretroviral drugs.
Barrier Therapeutics reported results from a phase III trial investigating Zimycan, a topical antifungal ointment for the treatment of Candida-associated diaper dermatitis. Results showed that Zimycan achieved statistical significance versus vehicle ointment for all endpoints. Data showed that the average reduction in the signs and symptoms score, was 72% with Zimycan versus 25% with the vehicle ointment. More than twice the subjects treated with Zimycan reached the primary endpoint, overall cure at day 14, as compared with vehicle. The double-blind, vehicle-controlled study enrolled 236 infants at 20 sites in the U.S. and Latin America. Subjects were given Zimycan or vehicle for seven days. The study will form the basis of the filing of an amendment to Barrier's pending NDA.