• Aileron Therapeutics Inc., of Cambridge, Mass., completed the first-in-human study of its lead stapled peptide drug, ALRN-5281. The long-acting growth hormone-releasing hormone agonist is in development for orphan endocrine disorders such as adult growth hormone deficiency and HIV lipodystrophy and broader indications in metabolic and endocrine disease. The initial Phase I evaluated the safety and tolerability of single ascending doses of ALRN-5281 administered by subcutaneous injection in healthy adults. Additional objectives included the evaluation of pharmacokinetics and exploratory pharmacodynamic biomarkers of ALRN-5281. Thirty-two subjects completed the study, with no serious adverse events, dose-limiting safety findings or tolerability issues leading to withdrawal. Findings will be used to optimize dose selection and frequency for ALRN-5281 as a potential best-in-class therapy.

• Opsona Therapeutics Ltd., of Dublin, Ireland, said it started a Phase II trial of OPN-305, a humanized IgG4 monoclonal antibody against Toll-like receptor 2, in renal transplant patients at high risk of delayed graft function (DGF). The randomized study is expected to enroll 278 patients in an adaptive design powered to show a 15 percent to 20 percent absolute benefit of OPN-305 over placebo in reducing the incidence of DGF. OPN-305 has orphan status in Europe and the U.S. for solid organ transplantation.

• PharmaMar SA, of Madrid, a subsidiary of Zeltia SA, said it completed enrollment in its Phase IIb study testing PM01183 vs. topotecan in resistant/refractory ovarian cancer. The open-label study is designed to confirm PM01183's activity in that indication. Pending results from the study, expected to be presented at medical conference later this year, PharmaMar said it will seek to launch a global Phase III program. PM01183 is designed to bind covalently to the minor groove of DNA to induce a specific degradation in tumor cells of RNA polymerase II, without interfering with other RNA polymerases.

• Sarepta Therapeutics Inc., of Cambridge, Mass., said it started dosing in a Phase I multiple-ascending-dose trial of AVI-7288, its lead candidate for the treatment of Marburg virus infection. The study, designated MAD, is designed to characterize the safety, tolerability and pharmacokinetics of the drug after repeat dosing in healthy adult volunteers. Sarepta is developing AVI-7288 under a contract from the Department of Defense.