Date: 2014-07-23
Type of
information: Publication of results in a medical journal
phase: 1
Announcement: publication of results in the Annals of Allergy, Asthma and Immunology and in The Journal of Biological Chemistry
Company: Dyax (USA - MA), now Shire (UK - USA)
Product: DX-2930 - lanadelumab
Action
mechanism: monoclonal antibody. DX-2930 is a novel, fully human monoclonal antibody inhibitor of plasma kallikrein (pKal). 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. Dyax is currently developing DX-2930 as a subcutaneous injection for the prevention of HAE attacks and expects to report data from a Phase 1b trial early in 2015. This antibody has been discovered using Dyax\'s proprietary phage display technology platform.
Disease: hereditary angioedema (HAE)
Therapeutic
area: Rare diseases
Country:
Trial
details:
Latest
news:
- • On July 23, 2014, Dyax announced the online publication of scientific data for DX-2930, an investigational fully human monoclonal antibody inhibitor of plasma kallikrein (pKal), in two peer-reviewed journals. Dyax is developing DX-2930 as a subcutaneous injection for prevention of HAE attacks.
The first paper titled \"A Phase 1 Study Investigating DX-2930 in Healthy Subjects\" by Chyung et al. was published online in the Annals of Allergy, Asthma and Immunology. The paper describes the positive results from the first-in-human clinical study of DX-2930 which met all of its objectives of assessing safety, tolerability and pharmacokinetics of this investigational drug candidate. These data indicate that DX-2930 has a long half-life in humans and thus the potential for prophylactic inhibition of pKal activity for the therapeutic treatment of HAE. DX-2930 is now being evaluated in a Phase 1b study in patients with HAE. The complete publication can be accessed online.
The second paper titled \"Inhibition of Plasma Kallikrein by a Highly Specific, Active Site Blocking Antibody\" by Kenniston et al. was published online in The Journal of Biological Chemistry. The paper describes the discovery and preclinical evaluation of DX-2930 as a long-acting inhibitor of pKal proteolytic activity. This paper is expected to appear in the September 2014 (Volume [289], Issue [29]) print issue of the journal. The complete publication can be accessed online.
- These data, combined with data that will be obtained from the ongoing Phase 1b study, will inform and guide the future clinical development of DX-2930.
Is
general: Yes
