A Hong Kong-based biotech company is working with a range of university partners to develop a groundbreaking drug delivery system that could change the way eye diseases are treated. Alephoson Biopharmaceuticals, founded in 2019, is in the process of conducting global clinical trials for a novel technology aimed at delivering drugs for age-related macular degeneration (AMD) and diabetes-related macular edema (DME) through eyedrops rather than invasive injections.
The company’s technology combines a proprietary cell-penetration peptide (CPP) with biologic medication, creating a drug delivery system that may offer a safer, more convenient alternative to current treatments. If successful, this method could replace the need for patients to undergo regular needle injections into the back of the eye, a procedure often required for up to five years.
Alephoson’s CEO and co-founder, Benjamin Lee, shared the company’s ambitious plans for the future. “As a research-and-development-focused company, we are partnering with university hospitals in Hong Kong, mainland China, across Asia, and the United States for our clinical trials,” said Lee. “We expect to complete a preclinical toxicity study in the next 12 months, after which we aim to seek approval from the U.S. Food and Drug Administration for Phase 1 and 2a trials, scheduled to begin early next year.”
The idea for this innovative drug delivery system originated from Professor Wei Gang, co-founder of Alephoson and deputy director of the Department of Pharmaceutics at Fudan University in Shanghai. Wei first conceived the idea during his time as a visiting scholar at the University of Maryland in 2008. His research demonstrated promising results, showing that the CPP could effectively deliver drugs to the back of the eye, an area difficult to reach using traditional delivery methods.
Dr. Marten Brelen, an Alephoson scientific adviser, will lead the planned Phase 1 trial, which will focus on the safety, side effects, and optimal dosage of the treatment for AMD patients. The trial is being funded by the Hong Kong government’s General Research Fund to support university investigations.
The current standard of care for both AMD and DME involves anti-vascular endothelial growth factor (anti-VEGF) injections, which offer superior outcomes compared to other treatments like laser therapy and steroids. However, anti-VEGF injections are often considered burdensome due to their frequency and the risk of serious side effects, such as infection, cataract formation, and retinal detachment.
Dr. Brelen, an associate professor of ophthalmology at the Chinese University of Hong Kong, noted that these injections typically cost around HK$10,000 (US$1,284) per shot, placing a financial strain on patients, as the procedure is not covered by Hong Kong’s public health system.
Alephoson’s planned clinical trials will involve 40 to 60 patients with DME across university hospitals in Hong Kong, Singapore, Taiwan, South Korea, and the United States. Professor Nguyen Quan of the Byers Eye Institute at Stanford University will lead the study.
The company is currently in the final stages of its Series A fundraising, with a goal to raise US$10 million to support preclinical and Phase 1/2a clinical development.
The potential impact of the technology is vast. AMD, which is the leading cause of vision loss in individuals aged 50 and older, affects millions of people worldwide. According to researchers at Johns Hopkins University, approximately 1.85 million people were blind due to AMD in 2020, with 6.23 million others experiencing moderate to severe vision impairment. DME, a complication of diabetes, affects an estimated 5.47% of diabetic patients globally. The number of people living with diabetes is growing exponentially, with the World Health Organization estimating that 830 million people were living with the condition in 2022, compared to 1990.
Alephoson’s eyedrop-based therapy could offer a much-needed advancement in the treatment of these prevalent eye diseases, ultimately improving patient outcomes and reducing the physical and financial burden of current injection-based treatments.
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