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news.The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for the investigation of Dyax's DX-2930, an investigational fully human monoclonal antibody inhibitor of plasma kallikrein (pKal), for hereditary angioedema (HAE).
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DX-2930 is currently being developed by the company as a subcutaneous injection for prevention of HAE attacks.
The company noted that uncontrolled pKal activity leads to excessive generation of bradykinin, a vasodilator thought to be responsible for the localized swelling, inflammation and pain characteristically associated with HAE.
The breakthrough therapy status is supported by the interim results of the company’s Phase Ib clinical trial of DX-2930 in HAE patients.
Dyax Research and Development executive vice-president and chief medical officer Burt Adelman said: "Receipt of Breakthrough Therapy designation is a key milestone for the DX-2930 development program.
"We look forward to taking full advantage of the opportunities that Breakthrough Therapy designation allows in order to maximize the possibility of a rapid path to approval."
The trial met all objectives evaluating safety, tolerability and pharmacokinetics of multiple subcutaneous administrations of DX-2930.
In addition, DX-2930 also showed statistically significant reductions in attack rate compared to placebo in a pre-specified proof-of-concept efficacy analysis.