Dyax Corp. DYAX announced positive safety, pharmacokinetic, biomarker and efficacy results from an ongoing multi-center, randomized, double-blind, placebo-controlled, multiple-ascending dose phase Ib study on DX-2930. The company is developing the candidate for the prevention of hereditary angioedema (HAE) attacks.
According to Dyax, the study met all its primary objectives. Pharmacokinetic results showed that DX-2930 has a linear, dose-dependent exposure with a mean elimination half-life of about 14 days across all dose groups (30 mg, 100 mg, 300 mg and 400 mg). Additionally, pharmacodynamic results from two separate exploratory biomarker assays demonstrated plasma kallikrein inhibition in an ex-vivo setting in a dose- and time-dependent manner. DX-2930 was well tolerated among the patients.
Moreover, Dyax emphasized that DX-2930 led to statistically significant reductions in the attack rate compared to placebo.
Along with data from the phase Ib study, Dyax announced the receipt of fast track designation for DX-2930 for HAE from the FDA. The company intends to convey these results to the FDA and leverage the facilities of fast track status to pave the way for rapid approval.
According to the company, HAE affects approximately 1 in 10,000 people to 1 in 50,000 people globally. We note that Shire’s SHPG Firazyr and Cinryze are already approved for the treatment of HAE attacks.
Dyax carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Cytokinetics, Inc. CYTK and Horizon Pharma plc HZNP. Both carry a Zacks Rank #1 (Strong Buy).
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