See better ways to develop eye drugs, character biology landed at $93 million for two trials in dry AMD

Clinical trials are often the first observation of how experimental drugs work in humans. Roles Biosciences are entering the clinic using human data generated by the company already mastered. These data provide a method for the role’s approach to target age-related macular degeneration and also indicate which patients are most likely to respond to treatment. Now, the startup has two leading programs with $93 million in earning clinical proof of concept.

The Series B financing announced Wednesday is led by Amoon and Luma Group, both new investors in Jersey City, New Jersey.

Age-related macular degeneration (AMD) damages the macula, which is the center of the retina. In wet AMD, blood vessels form subretinal, resulting in swelling and bleeding. In more common dry AMD, thinning of macula is driven by protein and lipid accumulation. Both forms of AMD lead to loss of central vision in the patient. More than 18 million people in the United States, aged 40 and older, suffer from early AMD. The dry form is more common, accounting for an estimated 85% of AMD cases, according to the American Society of Retinal Experts.

Although some drug studies begin with goals, the role studies begin with patients. Role CEO Cheng Zhang said the rationale for this approach is the heterogeneity of dry AMD, which means that many factors in the development and progression of the disease vary from patient to patient. Working with eye treatment centers across the country, the role recruited more than 6,500 patients with intermediate and advanced dry AMD. Study participants received no treatment. Observational studies collected data from electronic medical records and imaging. To date, the patient data for the study are about seven years.

Roles use artificial intelligence to analyze their accumulated data. In addition to looking for genetic signs of disease incidence, personality also looks for signs of disease progression. Doing so could be done with how regulators evaluate the impact of experimental treatments as it weighs potential approvals, Zhang said. This approach also provides information on clinical trial design. Character can prioritize the trial endpoint where the drug may have the greatest effect.

“We are looking for progress in treating disease,” Zhang said. “The role increases the choice of these goals to be associated with the FDA-identifiable endpoints of clinical progress. This is novel insight.”

Characteristic drug CTX114 addresses functional genetic loss associated with AMD risk and progression. This progression is also associated with the growth of geographical atrophy (GA) lesions, which are retinal damage developed from later stages of dryness AMD. Currently available for GA, it is currently available for drugs in the therapy called complement inhibitors. Apellis Pharmaceuticals' Syfovre received FDA approval in 2023; later that year, Astellas Pharma's Izervay won the FDA nod. Both drugs block specific complement proteins to slow GA progression.

Although CTX114 is also a complement inhibitor, Zhang said this feature involves different nodes in the complement pathway. Based on insights from observational research, Zhang said the role found that the node had stronger genetic support as a target. He also believes that CTX114 is a better engineered protein drug with preclinical data, suggesting that it has the potential to more effectively reduce the speed of GA progression while also maintaining vision.

Using the role drug candidate CTX203, the biotechnology is designed to prevent GA. Zhang said this is important because by the time patients develop GA, they have experienced irreversible vision loss. Observational studies of roles include the analysis of patients whose progression of AMD is associated with lipid accumulation. CTX203 is a complement inhibitor for lipid modulation. Zhang admitted that the target of role drugs was previously associated with AMD. Although Apellis and astellas drugs have lowered the modulation pathways of dry AMD and GA drugs, Zhang said that role drugs are not my premature treatment.

“We selected our goals in the supplemental pathway and developed beliefs in the goals and pathways themselves in 2020,” he said. “It’s not following the approval of these drugs, we decided to work with a couple. In fact, we are guided by patient data first.”

Zhang said that genetic risk factors suitable for patients can be determined by assays that have been available. It is possible to use two lead-characterized drugs in combination, because some patients have genetic risk variants associated with supplementation and lipids, contributing to their disease. But the initial plan was to test lead-characterized drugs separately, each at different stages of the disease. Phase one testing of both is expected to begin later this year.

The character's progress is connected to Bausch + Lomb's vision. In January, the character announced a partnership with the eye care giant. The initial focus was on AMD drug research, but the alliance could later expand to other eye diseases. Bausch + Lomb paid an undisclosed upfront payment and also provided research funding. Zhang said that this alliance does not include CTX203 and CTX114, which are still entirely owned by characters. However, given the heterogeneity of AMD, other targets found by role studies may lead to new drugs developed by Bausch + Lomb. Based on the progress of this research, roles can earn milestone payments and royalties from the sale of commercial products.

Founded in 2019, the role is the research unit of Medicare Advantage insurance company Clover Health. The unit's drug development was originally called a clover therapeutic agent, informed by analysis of data from its parents and other data that determine the patient's subgroup. In 2022, the company got rid of Clover Health. The startup was renamed as Character Bioscience, which received $18 million in Series A financing.

The latest round of financing is led by new investors Amoon and Luma Group. The round also included participation from Bausch + Lomb and Jefferson Life Sciences, as well as early investor innovation efforts, Catalio Capital Management, S32 and KDT Ventures.

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