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Latest New Medical Therapy Trial Results

Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results are also searchable by therapeutic area beginning with the most recent updates.

Week of September 29, 2014

DBV Technologies has reported results of a phase IIb trial of Viaskin Peanut in peanut allergic patients. In the double-blind, placebo-controlled, multicenter trial, 221 patients highly allergic to peanut were randomized to either a 50μg, 100μg or 250μg peanut protein dose of Viaskin Peanut versus placebo. The trial was prospectively organized across the three dose levels with two patient strata composed of three different patient age groups: children (113 subjects ages 6-11) for the first stratum; and adolescents (73 subjects ages 12-17) plus adults (35 subjects ages 18-55) for the other stratum. All patients received a daily application of the Viaskin Peanut patch over a 12-month treatment period. A total of 56 patients were randomized to the Viaskin Peanut 250μg dose. In this arm, 50% of patients responded, compared to 25% in the placebo group, showing statistical significance (p=0.0108). Adolescents showed a trend toward efficacy, showing a response rate of 38.9% in the active arm v. 22.2% in the corresponding placebo group. A statistically significant improvement in the adolescents’ ability to consume peanut protein also was observed, as the LS mean in change of CRD versus placebo of this subgroup was 276mg (p=0.047). The IgG4 increase observed in adolescents, a 3.3 fold increase over 12 months, suggests the beginning of a successful desensitization process.

Lipocine issued results of a phase III trial of LPCN 1021 for hypogonadal men with low testosterone. The randomized, open-label, parallel-group, active-controlled study of hypogonadal males with low testosterone (< 300ng/dL) enrolled 315 subjects at 40 active sites. 210 were randomized to LPCN 1021 and 105 were randomized to the active control, for 52 weeks of treatment. LPCN 1021 subjects were started at 225mg Testosterone Undecanoate (TU) (equivalent to ~ 142mg of T) twice daily (BID and then dose titrated, if needed, up to 300mg TU BID or down to 150mg TU BID based on serum testosterone measured during weeks three and seven. In the EPS analysis, 88% of the subjects on active treatment achieved testosterone Cavg within the normal range with lower bound CI of 82%. Additionally, sensitivity analysis using the SS reaffirmed the finding that LPCN 1021 successfully met the FDA primary efficacy guideline, as 80% of the subjects on active treatment achieved testosterone Cavg within the normal range with lower bound CI of 74%. Mean Cavg was 447 ng/dL with coefficient of variance of 37%. Lipocine expects to file an NDA with the FDA in the second half of 2015.

Novavax released results of a phase I/II study of its H7N9 Avian Influenza VLP Vaccine Candidate H7N9 VLP with proprietary adjuvant Matrix-M. The study was conducted in 610 healthy subjects to evaluate the safety and immunogenicity of the H7N9 VLP with Matrix-M. The study was a dose-ranging, randomized, observer-blinded, placebo-controlled clinical trial to determine the contribution of Matrix-M to potential antigen dose-sparing regimens. Subjects were administered two identical doses of either placebo, 15μg of H7N9 VLP alone, or 3.75μg, 7.5μg or 15μg of H7N9 VLP in combination with either 25μg or 50μg of Matrix-M. Serology was taken on day zero, 21 and 42. The H7N9 VLP, with and without Matrix-M, was well-tolerated and demonstrated a safety profile similar to the company’s prior experience with another saponin-based adjuvant. Matrix-M adjuvanted formulations demonstrated a clear immunogenicity benefit relative to unadjuvanted antigen and a dose-response within the adjuvanted groups. Antigen dose-sparing was shown, such that even the 3.75μg dose of antigen with either tested dose of adjuvant gave immune responses statistically significantly greater than 15μg dose without adjuvant. The vaccine also elicited anti-neuraminidase (NAI) antibodies against N9, with 89 to 100% sero-response rates in the adjuvanted vaccine groups, and greater than 11-fold increases in geometric mean titers. Further clinical studies are being considered.