Alkahest announced the initiation of two Phase 2 clinical trials of ALK4290 in patients with the wet form of age-related macular degeneration (AMD).
"The initiation of these trials represents a significant step forward in our clinical development efforts and our commitment to the development of innovative treatments for a range of age-related diseases," said Karoly Nikolich, President and Chief Executive Officer of Alkahest. "In addition to advancing our plasma-derived products, such as lead asset GRF6019, we have also continued to progress our broader pipeline derived from our deep understanding of the plasma proteome and its role in age-related diseases. ALK4290 represents the first non-plasma-derived product in our pipeline, targeting CCL11, which is elevated in wet AMD and other age-related diseases."
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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.