SAN CARLOS, Calif., July 29, 2019 (GLOBE NEWSWIRE) — Alkahest, Inc., a clinical stage biotechnology company focused on developing transformative therapies to treat age-related diseases, announced that its phase 2a trial of AKST4290, an orally-administered small molecule CCR3 inhibitor, met the primary endpoint of achieving an increase in best corrected visual acuity (BCVA) in patients with refractory wet or neovascular age-related macular degeneration (nAMD). AKST4290 was also found to be safe and well-tolerated, meeting the secondary endpoint of the trial. The results were presented in an oral presentation at the 2019 American Society of Retina Specialists Annual Meeting (ASRS) on July 27, 2019 in Chicago by Michael Stewart, M.D., Chair, Department of Ophthalmology at the Mayo Clinic, Jacksonville.
“We are pleased to announce the positive data from this study of AKST4290 in anti-VEGF refractory patients, confirming the safety, tolerability, and improvement in BCVA that was observed in a previously reported phase 2 trial in patients with treatment-naïve nAMD,” said Karoly Nikolich, chief executive officer of Alkahest. “These trials present early, but intriguing data on the efficacy and safety of AKST4290 as an oral treatment for nAMD that warrant continued study.”
In this patient population who are no longer responding to treatment with anti-VEGF injections, twice-daily administration of AKST4290 for six weeks was safe and well tolerated, with 72% of patients showing maintenance or improvement in BCVA. The mean change across six weeks of treatment in this refractory population was an increase of +2.0 letters gained according to the ETDRS system. 8% of subjects gained ten or more letters. AKST4290 was administered as a monotherapy without concomitant use of anti-VEGF therapy. There were no serious adverse events or adverse events leading to discontinuation of treatment.
Dr. Michael Stewart, M.D., commented: “Currently, intravitreal injections of anti-VEGF drugs constitute the standard of care in nAMD. Though efficacious, these treatments are not only burdensome and expensive for patients and the healthcare system; some patients cease to respond to ongoing treatment, risking further vision loss. The results of AKST4290-202 combined with the results of the AKST4290-201 treatment-naïve study shared earlier this year present an early but exciting potential oral alternative to intravitreal injections and I look forward to further studies.”
The ALK4290-202 study was a phase 2a trial that evaluated the therapeutic effects and safety of a six-week oral treatment regimen of AKST4290 400 mg twice per day (800 mg total) in patients refractory to anti-VEGF treatment as defined by persistent fluid and loss of vision despite greater than three anti-VEGF injections. The study included 26 evaluable subjects. The primary endpoint was mean change in best corrected visual acuity (BCVA) from baseline as measured by EDTRS testing methods. Safety was the secondary endpoint measured by the incidence and severity of adverse events. Exploratory endpoints included therapeutic effect on disease morphology and an exploration of biomarkers, with analysis ongoing.
AKST4290 is an orally administered CCR3 inhibitor that blocks the action of eotaxin, an immunomodulatory protein that increases as humans age and with specific age-related diseases. By targeting eotaxin and its downstream effects, AKST4290 may reduce the hallmark inflammation and neovascularization of neovascular AMD while also acting more broadly to reduce inflammation associated with many age-related diseases.
Alkahest is a clinical stage biopharmaceutical company dedicated to developing treatments for neurodegenerative and age-related diseases with transformative therapies targeting the aging plasma proteome. The Alkahest pipeline includes multiple therapeutic candidates ranging from selected plasma fractions to protein-targeted interventions which aim to slow the detrimental biological processes of aging. Alkahest is developing novel plasma-based therapies in collaboration with Grifols, a global healthcare company and leading producer of plasma therapies. For further information see www.alkahest.com or follow us on Twitter @AlkahestInc.