Dyax Corp. presented two oral presentations describing clinical data from its DX-2930 Phase 1b study at the American College of Allergy, Asthma, and Immunology (ACAAI) Annual Meeting. DX-2930 is an investigational fully human monoclonal antibody inhibitor of plasma kallikrein (pKal) being developed for the prevention of HAE attacks.
Burt Adelman, M.D., Executive Vice President of Research and Development and Chief Medical Officer at Dyax, said: “Collectively, these results support further clinical investigation of DX-2930 as a prophylactic treatment for HAE. We remain on track to enroll the first patient in our Phase 3 clinical trial for DX-2930 for HAE prophylaxis by year-end 2015.”
Final Results of a Phase 1b Study demonstrated that DX-2930 was well tolerated at all dose levels. There were no deaths or subject discontinuations due to an adverse event. There were no serious adverse events in subjects treated with DX-2930 and no evidence of dose-limiting toxicity. There was no safety signal in treatment-emergent adverse events, clinical laboratory results, vital signs, or electrocardiograms. Subcutaneous injection was well tolerated.
Post-hoc analyses of the Phase 1b study of DX-2930 in patients with HAE were conducted to determine if the clinical response to DX-2930 was influenced by factors such as historical attack rate, functional C1-INH levels, or the amount of cleaved (2-chain) high-molecular-weight kininogen (HMWK). C1-INH function in HAE patients ranged from 0 to 45% of normal. Neither historical nor observed attack frequency was related to baseline C1-INH levels, and baseline levels of 2-chain HMWK also did not correlate with historical attack rates. As expected, levels of 2-chain HMWK at baseline were inversely correlated with levels of functional C1-INH. It was observed that treatment with 300 or 400 mg DX-2930 reduced levels of 2-chain HMWK in a dose- and time-dependent manner, and these reductions were not influenced by historical attack rate or baseline C1-INH function. All subjects in the 300 and 400 mg dose groups with high baseline attack rates were attack-free during the Day 8 to 50 assessment period.