Hemera Biosciences’ dry AMD drug succeeds in Phase I safety study

In December 2016, the FDA granted Hemera “safe to proceed” status for an investigational new drug application on its lead product HMR59. A Phase I clinical trial to establish the safety profile of HMR59 and evaluate its maximum tolerated dose was fully enrolled in December 2017 with 17 patients diagnosed with advanced dry age-related macular degeneration (AMD) with geographic atrophy.

AMD is a common eye disorder among people over 50. It causes blurred or reduced central vision due to thinning of the part of the retina responsible for clear vision. AMD interferes with everyday activities such as driving, reading, writing, and cooking, and it is the leading cause of vision loss in people over 50—affecting more than 24 million people worldwide (8 million in the US). The dry (atrophic) type affects 80 to 90% of individuals with AMD. The disease starts as the dry type and, for a small minority, progresses to the wet type. There is no FDA-approved treatment today to halt the progression of dry to wet macular degeneration. Clinical evidence implicates the complement system in the etiology of AMD.

HMR59 is a gene therapy that was invented at Tufts University in the laboratory of Rajendra Kumar-Singh, PhD. Professor Kumar-Singh has worked on genetic therapies for diseases such as retinitis pigmentosa and AMD for over 20 years. HMR59, through its protein product soluble CD59, blocks the membrane attack complex, which forms during the terminal step in the complement cascade. HMR59 is designed to be administered as a single intraocular injection in an office setting. The hope is for the benefit of treatment to last the life of the patient.

In 2014, Tufts granted Hemera Biosciences an exclusive, worldwide license to key patent rights and technology covering HMR59 and its methods of use in AMD. In 2018 Tufts granted Hemera additional rights to molecules for treating systemic complement disorders, as well as applications of HMR59 in other diseases such as uveitis.

Adam Rogers, MD, assistant professor of ophthalmology at Tufts University School of Medicine, is CEO of Hemera Biosciences. The company was co-founded by Dr. Rogers, Professor Kumar-Singh, Jay S. Duker, MD, professor and chair of ophthalmology at Tufts Medical Center and Tufts University School of Medicine, and Elias Reichel, MD, professor and vice-chair of ophthalmology at Tufts Medical Center and Tufts University School of Medicine.

Hemera is currently raising Series B financing to undertake a Phase II clinical trial of HMR59 that will start in early 2019.