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Latest New Medical Therapy 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.
Creabilis issued positive results from a phase IIa trial of CT327 for the treatment of atopic dermatitis. This trial enrolled 15 subjects in Switzerland who received CT327 topically 0.1% cream twice daily for 15 days or placebo. A clinically significant improvement in symptoms was seen after eight days of treatment with CT327, as measured by change in mEASI (modified eczema area and severity index) score from baseline. Onset of efficacy was seen at three to five days of treatment. The greatest patient-reported benefit was in nighttime itch. CT327 was safe and well tolerated with no serious adverse events and no reported site irritation.
Inhibitex reported results from a phase II trial of FV-100 for the treatment of shingles. This controlled, double-blind study enrolled 350 subjects, aged 50 years and older, across several US sites. The subjects were equally randomized to one of three treatment arms: 200 mg or 400 mg FV-100 administered once daily or 1,000 mg valacyclovir (standard of care) administered three times per day. Both doses of FV-100 showed improvement over valacyclovir in the primary endpoint, the reduction in the severity and duration of shingles-associated acute pain over the first 30 days post-infection (3% and 7%, difference). The the 200 mg and 400 mg FV-100 arms also resulted in a respective 4% and 14% reduction in the burden of shingles-associated pain over the first 90 days compared to the valacyclovir arm. In addition, 18% and 12% of subjects receiving 200 mg and 400 mg FV-100, respectively, developed PHN, compared to 20% of the valacyclovir-treated subjects, resulting in relative treatment differences of 12% and 39%, respectively. In the valacyclovir arm the time to lesion crusting was faster than the FV-100 arms; however, no differences were noted between the treatment arms on time to full lesion healing. The overall tolerability and side effect profile of both doses of FV-100 was comparable to valacyclovir.
Lexicon released results from a phase II trial of LX2931 for the treatment of rheumatoid arthritis. This randomized, double-blind, placebo-controlled study enrolled 208 subjects on stable methotrexate therapy in the US and Eastern Europe. The subjects received a 70 mg, 110 mg or 150 mg dose once daily for 12 weeks. The primary endpoint was ACR20 (American College of Rheumatology- 20 percent improvement in symptoms associated with rheumatoid arthritis) at 12 weeks. Data demonstrated that subjects treated with the 150 mg dose showed an improvement in ACR20 response at week 12 (60% versus 49% for placebo). Those treated with 70 mg or 110 mg once daily did not indicate improvement in the ACR20 at week 12 (44% and 41% response rates, respectively) relative to placebo. Adverse events were mild-to-moderate.
Nektar Therapeutics reported results from a phase II trial of NKTR-102 for metastatic breast cancer. This two-stage design study enrolled 70 women who had failed a prior taxane therapy. Two dose regimens of single-agent NKTR-102 (145 mg/m2) were under evaluation; every 14 days (q14) and every 21 days (q21). Data are from 66 evaluable subjects. The confirmed overall response rate (ORR) was 32% for the q14d schedule and 26% for the q21d schedule, including two confirmed complete responses (CRs) on the q14d schedule. An additional four subjects had near CRs, with 100% disappearance of all target lesions. The combined ORR for all evaluable patients was 29%. The clinical benefit rate for the 66 evaluable patients was 41% (defined as CR+PR+SD greater than or equal to 6 mos). The confirmed ORR was maintained in poor prognosis and heavily pre-treated subsets within the study. The preliminary median progression-free survival for all subjects was 20 weeks.
