Risuteganib

SHANGHAI, Sept. 25, 2023 /PRNewswire/ -- AffaMed Therapeutics ("AffaMed"), a global biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders, today announced that China's National Medical Products Administration has approved AffaMed's Clinical Trial Application (CTA) to investigate the efficacy and safety of Risuteganib (Luminate®), its First-in-Class, new Mechanism of Action ophthalmic intravitreal injectable product candidate for the treatment of Intermediate Dry Age-related Macular Degeneration (Dry AMD). Under the CTA approval, AM011 is expected to become the first product in China to enter Phase 3 development for the treatment of Dry AMD. In December 2021, AffaMed Therapeutics entered into a licensing agreement with Hanmi Pharmaceutical Co., Ltd. ("Hanmi") for the manufacturing, development and commercialization of Risuteganib (Luminate®) in Greater China (mainland China, Hong Kong, Taiwan and Macau). Dr. Dayao Zhao, CEO of AffaMed commented: " To date there is no approved and effective treatment in China for patients suffering from Dry AMD which represents the vast majority of the AMD patient population. We are encouraged by the Chinese regulator's efficiency in approving our application for this innovative therapy. We are looking forward to bringing this innovative treatment to Dry AMD patients in Greater China as soon as possible." About Dry AMD Age-related macular degeneration (AMD) is a progressive blinding disease that currently affects millions of people worldwide and is the leading cause of blindness in the elderly. Dry AMD accounts for approximately 80-90% of the total AMD patient population. As of 2020, the number of Dry AMD patients in China was estimated at 33.5 million and is projected to exceed 43 million by the end of this decade[1]. There are currently no approved therapies for the treatment of Intermediate Dry AMD. About Risuteganib (Luminate®) In 2015, Hanmi acquired the exclusive rights for intravitreal use from Allegro Ophthalmic LLC, for the development and commercialization of Risuteganib (Luminate®) in Korea and China. Luminate® is a first-in-class integrin regulator with a novel mechanism of action to regulate multiple pathways of oxidative stress response, including mitochondrial dysfunction, which contributes to diseases such as intermediate Dry AMD. Risuteganib (Luminate®) has successfully met the primary endpoint in a Phase 2 proof of concept clinical trial with statistically significant vision improvement in patients with intermediate Dry AMD versus placebo. Allegro has entered into a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration to advance Risuteganib (Luminate®) into a Phase 2b/3 pivotal registration program. About AffaMed Therapeutics AffaMed Therapeutics is a clinical stage biopharmaceutical company focused on developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders for patients in Greater China and around the world. The leadership team at AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations at leading multi-national biopharmaceutical companies in China and globally. About Hanmi Pharmaceuticals Hanmi Pharmaceutical, founded in 1973, is an R&D-oriented biopharmaceutical company representing Korea. After the establishment by Pharmacist Lim Sung-ki, it was converted into a holding company system in 2010 and incorporated into a subsidiary of Hanmi Science. Hanmi Pharmaceutical invests more than 15% of its sales in R&D every year and is developing 26 drug candidates for innovative new drugs in three major fields; 1) Biologics: LAPSCOVERY platform applied long-acting pipeline; 2) NCE: Primarily oncology and auto-immune disease targeted pipelines; and 3) Fixed-dose combination programs. Hanmi Pharmaceutical's representative new drug target diseases include metabolic diseases such as obesity, rare diseases, and various types of cancer. In addition, Hanmi Pharmaceutical operates production facilities ranging from raw materials to chemicals and biopharmaceuticals and has more than 5,000 employees in Korea and China. SOURCE AffaMed Therapeutics Ltd.

- Intermediate Dry AMD Treatment Is a Significant Unmet Need - Mitochondrial Stabilizing Candidate Risuteganib Has Shown Best Corrected Visual Acuity Gains in Dry AMD Patient Population Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel mitochondrial stabilizers for the treatment of ocular diseases, today announced that the Company has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design of its Phase 2b/3 clinical trial of risuteganib (Luminate®) for the treatment of intermediate, non-exudative age-related macular degeneration (dry AMD). Finalization of this assessment indicates that the FDA agrees that critical elements of the overall protocol design (e.g., entry criteria, dose selection, endpoints, and planned analyses) are adequate and acceptable for a study intended to support a future marketing application. "We are excited that the overall protocol design of our Phase 2b/3 dry AMD clinical trial was finalized by the FDA," said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics, LLC. "The agreement by the FDA of the SPA provides a clear regulatory path for our first-in-class drug, risuteganib, for the treatment of intermediate dry AMD for an unmet medical need. This is important because dry AMD leads to irreversible, and in many cases catastrophic, vision loss. A therapy to treat this disease is greatly needed." The agreement by the FDA of the SPA provides a clear regulatory path for risuteganib for intermediate dry AMD. The Phase 2b/3 study design is based on Allegro's successfully completed U.S. Phase 2a study, in which the primary endpoint was the proportion of subjects with a gain of ≥ 8 letters of vision with two risuteganib injections versus one sham treatment. The Phase 2a trial was a prospective, randomized, double masked, placebo-controlled, multi-center U.S. study that evaluated the safety and efficacy of risuteganib in patients with intermediate dry AMD. The primary endpoint was met, with 48 percent of patients in the risuteganib arm at week 28 and 7 percent of patients in the sham group at week 12 gaining ≥ 8 letters from baseline (p=0.013). Risuteganib was found to be safe, with no reported drug related serious adverse events (SAEs). Additional findings that support the visual acuity improvement included improvements in retinal sensitivity (microperimetry) and color vision (Lanthony color test). The Phase 2b/3a study will evaluate efficacy at 52 weeks and safety through 96 weeks. Patients will receive 5 intravitreal injections (IVTs) 12 weeks apart with continued IVT treatment during the follow-up safety portion of the study. The primary endpoint of the study is the improvement in best corrected visual acuity (BCVA) at 52 weeks in the active risuteganib group vs the sham control group. This study design also includes threshold OCT screening, such as minimum ellipsoid zone and photoreceptor layer thickness, that strongly predicts BCVA response to treatment, thus helping clinicians predict outcomes and select the patients most likely to benefit from treatment. About Allegro Ophthalmics, LLC Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro's lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its oxidative stress-stabilizing portfolio, Allegro developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in two ex-U.S. studies in humans. For more information, visit www.allegroeye.com. SOURCE Allegro Ophthalmics