SAN CARLOS, Calif., — Alkahest Inc. (“Alkahest”), a clinical-stage biotechnology company focused on developing innovative therapies to treat age-related diseases, today 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.”
“We are excited to advance ALK4290, which has demonstrated promising preclinical activity in animal models as an oral monotherapy agent,” said Sam Jackson, Alkahest’s Chief Medical Officer. “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.”
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.
Alkahest is a privately-held clinical-stage company based in San Carlos, CA developing treatments for age-related diseases, with an emphasis on neurodegeneration — a key medical challenge for our generation. The company’s breakthrough 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. Alkahest is developing novel plasma-based products in collaboration with Barcelona, Spain-based Grifols, a global healthcare company and leading producer of plasma therapies.
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