Adocia SA, of Lyon, France, reported results from a phase II trial evaluating its fast-acting formulation of recombinant human insulin, Hinsbet, in comparison to commercial products Humalog (insulin lispro) and Humulin (recombinant human insulin), both sold by Indianapolis-based Eli Lilly and Co. The study met its primary endpoint, measuring the increase of recombinant human insulin bioavailability during the first hour, with data showing that Hinsbet has an early effect equivalent to that of a fast-acting insulin analogue, Humalog, and twice superior to that of regular recombinant human insulin, Humulin. Hinsbet incorporates Adocia's Biochaperone technology. The double-blind, crossover study enrolled 36 type 1 diabetics.

Akaal Pharma Pty Ltd., of Melbourne, Australia, reported results from a randomized, double-blind, placebo-controlled phase I trial of AKP-11, a topical sphingosine 1-phosphate receptor-1 modulator for the treatment of mild to moderate plaque psoriasis. Topical application to psoriasis patients for 28 days was found to be safe, well tolerated and resulted in a significant reduction in plaque severity. AKP-11 reduced the local psoriasis severity index and demonstrated significant efficacy when compared to baseline (p = 0.0016). No detectable plasma levels of AKP-11 were found in the pharmacokinetic analysis, which is attributable to the large therapeutic index of AKP-11. The study enrolled 16 subjects.

Albireo AB, of Gothenburg, Sweden, said it initiated a phase II trial of A4250, its lead compound for cholestatic liver disease and nonalcoholic steatohepatitis. A4250 is designed to act locally in the gut to inhibit the ileal sodium dependent bile acid transporter. The crossover study will aim to demonstrate efficacy and safety of the drug in patients with primary biliary cirrhosis and cholestatic pruritis. In addition to evaluation of changes in pruritus, the study will focus on changes in liver parameters known to be predictors of disease progression in liver diseases in general.

Zealand Pharma A/S, of Copenhagen, said partner Helsinn Healthcare SA, of Lugano, Switzerland, started a phase IIb dose-finding study of elsiglutide, a GLP-2 receptor agonist, for the prevention of chemotherapy-induced diarrhea (CID). The first patients out of a planned total of 600 with colorectal cancer who are treated with chemotherapy (5-FU-based regimens) have been dosed in the study. The trial includes a subgroup of 120 patients who will be treated also with an approved monoclonal antibody. The study objective is to assess the efficacy of three different doses of subcutaneous elsiglutide vs. placebo in the prevention of CID. The primary endpoint is the proportion of patients experiencing diarrhea of grade II or more during the first cycle of 5-FU-based chemotherapy. Data are expected in the first half of 2016.