Alkahest has initiated two Phase II clinical trials investigating ALK4290 for the treatment of patients with wet age-related macular degeneration (AMD).
One of the trials, named ALK4290-201, is a single-arm open-label study that aims to analyse the therapeutic effects and safety of a six-week oral treatment regimen of ALK4290 in newly diagnosed wet AMD patients.
The second single-arm open-label trial ALK4290-202 is designed to examine the therapeutic effects and safety of a similar treatment regimen to treat patients with refractory wet AMD.
To be conducted in Hungary and Poland, both trials will help examine the treatment-naïve patients, as well as patients who have not responded to or who are refractory to treatment with intravitreal injections of anti-vascular agents.
Alkahest president and CEO Karoly Nikolich said: “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.”
ALK4290 is a new orally available small molecule reported to be well-tolerated in previous clinical studies.
Alkahest chief medical officer Sam Jackson said: “Oral dosing is particularly advantageous from a patient convenience perspective when compared to the standard of care, which is currently administered via intravitreal injection.
“We look forward to continuing to work with clinical experts, patients and their families as we pursue this novel approach to the treatment of the leading cause of blindness in adults.”
AMD is a disease that blurs the sharp, central vision required for ‘straight-ahead’ activities, including reading, sewing, and driving.
It affects the macula, the part of the eye that allows an individual to see fine detail.