AffaMed Therapeutics, a China-based biotech firm, has announced the receipt of its first clinical trial approval in China for its pipeline candidate, Luminate (risuteganib; AM011). This development marks a significant milestone for the company, which acquired the Greater China manufacturing, development, and commercial rights to risuteganib from Hanmi Pharmaceutical, a South Korea-based company, in a deal valued up to USD 145 million in January 2022.
Risuteganib: A ‘Best-in-Class’ Integrin Modulator for Dry AMD
Risuteganib, known as Luminate, is a ‘best-in-class’ integrin modulator with a novel mechanism of action that can regulate multiple pathways of oxidative stress, including mitochondrial dysfunction. This mechanism is relevant to diseases such as mid-stage dry age-related macular degeneration (AMD), a leading cause of vision loss among the elderly.
Clinical Trial Significance and Market Potential
The clinical trial approval positions risuteganib to potentially become the first product in China to enter Phase III development for the treatment of dry AMD. Dry AMD accounts for approximately 80%-90% of the total AMD patient population, which is significant as there are currently no effective therapies available in China for this condition. With an estimated patient population of 33.5 million in 2020, projected to exceed 43 million by the end of the decade, the approval of risuteganib’s clinical trial in China represents a major step forward in addressing a significant unmet medical need.-Fineline Info & Tech
