Kriya Therapeutics Raises $313M to Advance Gene Therapy Pipeline for Chronic Diseases
Key Insights
Kriya Therapeutics (search) has secured $313 million in new funding to advance its pipeline of single-dose gene therapies targeting chronic conditions including geographic atrophy (search) and trigeminal neuralgia (search).
The company's lead candidate KRIYA-825 for geographic atrophy (search) has completed IND-enabling studies and is ready to enter clinical testing, while KRIYA-748 for trigeminal neuralgia (search) is also in advanced development.
The funding comes amid regulatory challenges facing the gene therapy sector, including recent safety concerns with AAV-based therapies and FDA restrictions on other approved gene therapies.
Kriya Therapeutics (search) has raised $313.3 million in a new financing round to advance its pipeline of single-dose gene therapies for chronic diseases, according to an SEC filing disclosed Friday. The North Carolina-based biopharmaceutical company did not identify the two participating investors in the regulatory document.
This latest funding round builds on the company's previous financing efforts, which included a $100 million Series B raise in July 2021, a $270 million Series C round in May 2022, and a $150 million extension in July 2023. Combined with the new funding, Kriya has now raised over $813 million to support its gene therapy development programs.
Advanced Pipeline Targets Multiple Chronic Conditions
Kriya's most advanced asset is KRIYA-825, a gene therapy designed to treat geographic atrophy (search) (GA), an ophthalmic disease characterized by late-stage age-related macular degeneration (search) that can eventually cause vision loss if left untreated. The therapy has cleared IND-enabling studies and is positioned to enter clinical testing. KRIYA-825 expresses a protein that disrupts the complement cascade (search), which has been implicated in the development and progression of GA. The gene therapy is specifically designed for in-office administration via injection into the eye.
Another near-completion pipeline candidate is KRIYA-748, targeting trigeminal neuralgia (search), a condition that worsens with age and is characterized by chronic pain on one side of the face. This gene therapy expresses an engineered ion channel designed to reduce the rate and severity of pain attacks in patients with the condition.
Both therapies utilize adenovirus-associated vectors (AAV) to deliver the therapeutic genes. Beyond these lead programs, Kriya is developing treatments for thyroid eye disease (search), focal epilepsy (search), and metabolic diseases including type 1 diabetes (search) and metabolic dysfunction-associated steatohepatitis (search) (MASH).
Sector Faces Regulatory Headwinds
The funding comes as the gene therapy sector confronts significant regulatory and clinical challenges. Recent months have seen increased scrutiny of AAV-based therapies following safety concerns. Sarepta Therapeutics reported two patient deaths linked to its gene therapy Elevidys for Duchenne muscular dystrophy (search), with a third death connected to the company's experimental gene trial for limb-girdle muscular dystrophy (search) using the same viral vector.
The FDA has also recently narrowed coverage of bluebird bio's Skysona to include only patients with cerebral adrenoleukodystrophy (search) who have no other treatment options, following detection of elevated blood cancer risk associated with the gene therapy.
Industry experts, including patient pioneer Donovan Decker, who was the first patient worldwide to receive gene therapy for a neuromuscular condition, have raised concerns about AAV vectors, noting they are difficult to re-dose without causing negative immune reactions.
Despite these sector-wide challenges, Kriya continues to advance its "one-time gene therapies" approach for treating chronic diseases across ophthalmic, metabolic, and neurologic conditions.