KRIYA-825

– Kriya anticipates up to 5 programs to enter clinic by the end of 2025 – – Current pipeline of gene therapies for common diseases spans three major therapeutics areas: ophthalmology, metabolic disease and neurology – – Company enters 2024 with cash balance of $325 million and runway into late 2026 – PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Kriya Therapeutics, Inc., ("Kriya") a biopharmaceutical company developing gene therapies for common diseases affecting millions of people around the world, today provided an update on its pipeline of gene therapies for prevalent conditions including geographic atrophy, thyroid eye disease, diabetes, NASH, trigeminal neuralgia and epilepsy. Kriya is advancing the first of its gene therapy product candidates into the clinic in 2024 and expects up to five programs in the clinic by the end of 2025. "Our mission is to revolutionize the field of medicine by delivering transformative, one-time gene therapies to patients suffering from common diseases," said Shankar Ramaswamy, M.D., Co-Founder and CEO of Kriya. "In parallel with our near-term goal of advancing up to five gene therapies into the clinic by the end of 2025, we remain deeply committed to our vision of significantly reducing the cost of manufacturing gene therapies through innovations in process sciences and product engineering.” Kriya's platform includes an end-to-end gene therapy product development engine that integrates cutting-edge research and computational biology with a scalable GMP manufacturing facility deploying next-generation processes and analytical characterization techniques. Kriya’s pipeline includes gene therapies across three major therapeutic areas: ophthalmology, metabolic disease and neurology. Its programs share the following features: direct-to-tissue delivery, validated biology, de-risked clinical and regulatory paths and large commercial markets. Kriya’s publicly disclosed programs are summarized below. Dr. Ramaswamy will share further information on Kriya’s portfolio during his presentation at the J.P. Morgan 42nd Annual Healthcare Conference on Tuesday, January 9th at 9:00 AM PT in San Francisco, California. Ophthalmology ProgramsGeographic Atrophy (GA): KRIYA-825 is designed as a one-time gene therapy expressing a fusion protein inhibiting complement C3 and C5, delivered by an in-office suprachoroidal injection with the objective of slowing GA lesion growth and vision loss. GA affects approximately two million people in the United States and the European Union. Existing treatment options require monthly or bimonthly physician-administered intravitreal injections that can be burdensome for patients. Kriya has designed KRIYA-825 for GA with the following potential goals in mind: Robust complement inhibition: A novel complement receptor 2 -complement receptor 1 (CR2-CR1) fusion protein—where the CR1 domain is designed to block the function of both C3 and C5, while the CR2 domain is designed to bind to cell surfaces where complement fragments deposit and cause damage;Multi-year durability: Adeno-associated virus (AAV)-mediated continuous expression of CR2-CR1 fusion protein following a one-time injection to eliminate the need for frequent intravitreal injections as required by currently available therapies for GA; andTargeted delivery: One-time suprachoroidal injection with the goal of achieving transduction of retinal cells while minimizing inflammation and overall patient burden. Thyroid Eye Disease (TED): KRIYA-586 is designed as a one-time gene therapy expressing an antibody blocking insulin-like growth factor-1 receptors (IGF-1R), delivered by an in-office peribulbar injection with the objective of reducing proptosis and diplopia as well as other key features of TED. Approximately one million people in the United States and the European Union have TED. The only FDA-approved treatment is an intravenously administered monoclonal antibody that works by blocking IGF-1R. Kriya has designed KRIYA-586 for TED with the following potential goals in mind: Minimized treatment burden: One-time, in-office peribulbar injection to eliminate the burdensome requirement for multiple infusions or injections;Focal delivery: Localized antibody expression in extraocular muscles and fat tissue to limit the potential for side effects that can be observed with systemically administered therapies; andLong-term durability: AAV-mediated antibody expression to deliver sustained improvements in proptosis and diplopia as well as other key manifestations of TED. For more information on Kriya's Ophthalmology programs, please visit the Ophthalmology page of our website. Metabolic Disease ProgramsDiabetes: KRIYA-839 is designed as a one-time gene therapy expressing insulin and glucokinase, delivered intramuscularly with the objective of driving durable glycemic control and reducing or eliminating the need for exogenous insulin. Of the approximately 90 million people in the United States and the European Union who have type 1 and type 2 diabetes, 17 million use insulin to manage their disease. Current treatments for type 1 diabetes require burdensome chronic insulin injections and constant treatment modification based on dietary intake and blood glucose monitoring. Kriya has designed KRIYA-839 for diabetes with the following potential goals in mind: Robust glycemic control: Improving time-in-range and lowering HbA1c to reduce the risk of long-term diabetic complications;Insulin independence: Enabling patients to achieve insulin independence while maintaining robust glycemic control; andMinimized treatment burden: Substantially reducing or eliminating the need for multiple daily injections of insulin with a one-time treatment. Nonalcoholic Steatohepatitis (NASH): KRIYA-497 is designed as a one-time gene therapy expressing the native FGF21 protein, delivered intramuscularly with the objective of reducing fibrosis, reversing steatosis, and improving the overall metabolic profile of patients with later stages of NASH with liver predominant pathology (F3 and compensated F4). NASH affects approximately 40 million people in the United States and the European Union. There are currently no FDA-approved therapies for the treatment of NASH. Kriya has designed KRIYA-497 for NASH with the following potential goals in mind: Robust anti-fibrotic activity: Expression of native FGF21 protein to drive natural ligand/receptor interactions and enhance biodistribution across multiple organs;Minimized treatment burden: One-time intramuscularly administered therapy to reduce complexity for patients who are often taking multiple other concomitant therapies; andContinuous expression: Consistent concentration of native FGF21 protein to limit Cmax-mediated gastrointestinal issues. For more information on Kriya's Metabolic Disease programs, please visit the Metabolic Disease page of our website. Neurology ProgramsTrigeminal Neuralgia (TN): KRIYA-748 is designed as a one-time gene therapy expressing a chemogenetically-gated ion channel, delivered through an injection into the trigeminal nerve with the objective of reducing the frequency and severity of debilitating paroxysmal pain attacks. Once expressed in the nerve, the channel is designed to selectively open in the presence of the orally-administered CNS-penetrant small molecule, varenicline (the FDA-approved generic medication for smoking cessation originally marketed under the brand name "Chantix®"), leading to the passage of chloride ions and reduced excitation of target neurons. Trigeminal Neuralgia affects approximately 400,000 people in the United States and the European Union. Current treatments include anticonvulsants, which can have significant tolerability issues and waning efficacy over time. Kriya has designed KRIYA-748 for trigeminal neuralgia with the following potential goals in mind: Pain reduction: Goal of reducing the frequency and severity of pain attacks by focally inhibiting neuronal hyperexcitability in the trigeminal nerve;Long-term durability: One-time administration of gene therapy to eliminate the need for cycling through anti-epileptic medications and surgical procedures; andRegulatable activity: Targeted delivery to the trigeminal nerve, additionally engineered with the ability to “turn off” the gene therapy through withdrawal of the orally-administered small molecule, varenicline. Focal Epilepsy: KRIYA-382 is designed as a one-time gene therapy expressing a chemogenetically-gated ion channel, delivered through a direct injection into epileptic foci within the brain with the objective of reducing the frequency and severity of seizures. Kriya’s epilepsy gene therapy uses a similar chemogenetic technology as is utilized in its trigeminal neuralgia program, described above. Focal epilepsy affects close to 5 million people in the United States and the European Union. Current treatments include first- and second-line antiseizure medications. A significant proportion of patients suffer from refractory epilepsy, many of whom are candidates for invasive neurosurgery. Kriya has designed KRIYA-382 for focal epilepsy with the following potential goals in mind: Seizure reduction: Goal of minimizing seizures by inhibiting neuronal hyperexcitability at epileptic foci;Long-term durability: One-time administration of gene therapy designed to eliminate the need for cycling through anti-epileptic medications; andRegulatable activity: Targeted delivery to epileptic foci, additionally engineered with the ability to “turn off” the gene therapy through withdrawal of the orally-administered small molecule, varenicline. For more information on Kriya's Neurology programs, please visit the Neurology page of our website. About Kriya TherapeuticsOur mission is to revolutionize medicine, with the ultimate goal of eliminating human suffering and enabling people to live without the burden of disease. Kriya is a biopharmaceutical company developing gene therapies to address common diseases affecting millions of people around the world. With operations in Palo Alto, California and Research Triangle Park, North Carolina, Kriya has raised over $600 million, which will be used to advance a broad pipeline of gene therapies for ophthalmology, metabolic disease and neurology. For more information, please visit www.kriyatx.com and follow us on LinkedIn and X.