16 May 2018 - - San Carlos, California-based clinical-stage biotechnology company Alkahest Inc. has commenced two Phase 2 clinical trials of ALK4290 in patients with the wet form of age-related macular degeneration (AMD), the company said.
The ALK4290-201 study is a single-arm open-label Phase 2 clinical trial designed to evaluate the therapeutic effects and safety of a 6-week oral treatment regimen of ALK4290 in patients with newly diagnosed wet AMD.
The ALK4290-202 study is a single-arm open-label Phase 2 clinical trial designed to evaluate the therapeutic effects and safety of a similar treatment regimen in patients with refractory wet AMD.
Both studies will be conducted in Hungary and Poland which will allow evaluation of treatment-naïve patients, as well as in patients who have not responded to or who are refractory to treatment with intravitreal injections of anti-vascular agents.
ALK4290 is a novel orally-available small molecule which has been well-tolerated in previous clinical studies. More than 165 participants have received ALK4290 across multiple studies. Alkahest acquired ALK4290 from Boehringer-Ingelheim and has exclusive rights for development and commercialization worldwide.
Privately-held Alkahest is focused on developing innovative therapies to treat age-related diseases, with an emphasis on neurodegeneration.
The company's research has discovered changes in the plasma proteome in healthy aging and age-related diseases, and demonstrated that factors in the blood plasma can be augmented or inhibited in order to reverse detrimental effects of aging in both normal aging and disease models in animals.