Dyax Corp. (NASDAQ:DYAX) today announced positive results from the first-in-human clinical study of their investigational product, DX-2930. The Phase 1a study met all objectives of assessing safety, tolerability and pharmacokinetics of DX-2930. Discovered by Dyax, DX-2930 is a fully human monoclonal antibody inhibitor of plasma kallikrein being developed for the prevention of hereditary angioedema (HAE) attacks.
The study was a randomized, double-blind, placebo-controlled, single dose escalating trial in healthy subjects. Subjects received a single dose of DX-2930 [0.1, 0.3, 1.0, or 3.0 mg/kg] or placebo by subcutaneous injection, with 6 subjects receiving active drug and 2 subjects receiving placebo per dose level. A total of 32 subjects were enrolled, randomized, and dosed.
Study results demonstrated that DX-2930 was well tolerated at all dose levels. There were no serious adverse events or evidence of dose-limiting toxicity. Headache was the most commonly reported adverse event and occurred at a rate of 25% in both the DX-2930 and placebo dose groups.
Pharmacokinetic results demonstrated that DX-2930 has linear, dose-dependent exposure and a mean elimination half-life of 17 to 20 days across dose groups, following a single injection to healthy subjects. Pharmacodynamic results from two different exploratory biomarker assays confirmed ex vivo plasma kallikrein inhibition in a dose and time dependent manner.
The safety, tolerability, pharmacokinetic and plasma kallikrein inhibition results of the Phase 1a study support advancing the DX-2930 development program into a Phase 1b study mid-2014. The Phase 1b study will be a randomized, double-blind, repeat-dose, dose-escalation study conducted at multiple sites to evaluate DX-2930 in patients with HAE.
"We are very excited by the study results," said Burt Adelman, M.D., Executive Vice President and Chief Medical Officer at Dyax. "With these results we continue to be impressed by DX-2930 and are encouraged that our scientific hypotheses are on track. We look forward to initiating our Phase 1b study of DX-2930 in HAE patients in mid-2014.”