Cyllene Therapeutics

Cyllene Therapeutics Presents Interim Data from Phase 1b/2a Clinical Trial Showing EG110A Reduced Urinary Episodes in Patients with Spinal Cord Injury at the International Continence Society (ICS) Conference

• Clinically relevant reduction in urinary incontinence episodes consistently maintained overtime including in the initial set of patients reaching end of study at 52 weeks
• Treatment was well tolerated, with no serious drug related side effects or dose-limiting toxicity
  
  

Paris and New York, Oct. 07, 2026 (GLOBE NEWSWIRE) -- Cyllene Therapeutics SAS (“Cyllene Tx”), a leader in site-specific, non-systemic DNA medicines for the treatment of prevalent chronic neurological disorders, today announced presentation of interim clinical data from the first two dose cohorts of its Phase 1b/2a trial showing that treatment with EG110A resulted in consistent and clinically relevant reductions in urinary incontinence episodes up to 52 weeks in people with spinal cord injury (“SCI”) with neurogenic detrusor overactivity (“NDO”). This debilitating and prevalent bladder disorder is characterized by uncontrolled urinary incontinence. The data, presented at the 56^th International Continence Society Annual Meeting in Maastricht, the Netherlands, also showed EG110A to be well tolerated, with no severe drug related side effects or dose-limiting toxicity.

EG110A is a non-replicating HSV-1 vector designed to selectively silence the calcitonin gene-related peptide-positive (CGRP+) sensory neurons responsible for bladder muscle overactivity, while preserving normal bladder function. EG110A is being evaluated in an ongoing Phase 1b/2a, open-label, dose-escalation trial for the treatment of NDO in people with SCI.

“Historically, lower urinary tract therapeutics addressed bladder contractility exclusively despite the critical role that sensory dysfunction plays in conditions such as overactive bladder and urge incontinence. EG110A could represent a dramatic shift in the treatment of lower urinary tract dysfunction by targeting the sensory nerves involved in bladder control directly. The impressive results seen with EG110A in patients with SCI validate this novel approach and pave the way for potential application across broad populations of patients suffering from neurogenic and idiopathic lower urinary tract symptoms,” said Evgeniy Kreydin, MD, Assistant Professor of Urology at the University of Southern California (USC) and chief of urology at Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center, one of the principal investigators on the study who presented the data.

Treatment with EG110A at the combined low- and mid-level dose was associated with an 87% reduction in urinary incontinence episodes at 12 weeks in responder patients (n=6) across both cohorts. These results were maintained to end of the study (52 weeks) in the low dose cohort (n=3). EG110A was well tolerated in all patients, with no drug-related serious adverse event, no dose limiting toxicity and no study discontinuations due to adverse events. The only side effects reported were mild fever and nausea in the immediate post injection period. As with other nrHSV-1 therapies, no pretreatment with immunosuppressant regimen was included in the protocol.

“The data presented today continue to show that our first, low-dose, patient cohort consistently achieves a clinically relevant reduction in urinary incontinence episodes following treatment with EG110A, which lasts for up to 52 weeks. We are still early in clinical development, so if these remarkable results are replicated in larger studies, we believe it has the potential to give NDO patients a better quality of life,” said Cornelia Haag-Molkenteller, MD, PhD, Chief Medical Officer at Cyllene Tx. “The study is ongoing with a mid-range dosing cohort that has now reached 12 weeks. We are seeing comparable safety and efficacy results in responder patients, so look forward to reporting data when this cohort also completes 52 weeks.”

The Phase 1b/2a, open-label, dose-escalation study (ClinicalTrials.gov ID: NCT06596291) is currently enrolling the third cohort of 16 adult participants with NDO following SCI, who have persistent urinary incontinence after standard of care therapy and who perform clean intermittent catheterization on a regular basis. Participants receive a single treatment course consisting of multiple intradetrusor injections of EG110A. The study is being conducted at four leading US institutions located in California, Ohio, Pennsylvania and Texas.

This research was supported, in part, by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $3,165,836, through the Spinal Cord Injury Research Program under Award No. HT9425-25-1-0505. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

About Neurogenic Detrusor Overactivity (NDO)

NDO is a bladder dysfunction caused by neurological injury or disease, which causes uncontrolled urinary incontinence, risk of kidney damage as well as urinary tract infections than can lead to death in 5-10% of the SCI population. NDO with urinary incontinence is a serious, chronic, and frequently permanent condition, highly prevalent in people living with SCI, multiple sclerosis or Parkinson’s disease. Altogether, NDO affects at least 2 million patients across the seven major markets and has a significant impact on their quality of life. The European Association of Urology recently estimated that incontinence caused by NDO and other indications, such as overactive bladder, represents a growing economic burden of over €69.1 billion in 2023 in Europe.

About Cyllene Therapeutics

Cyllene Therapeutics (“Cyllene Tx”) is a leader in site-specific, non-systemic DNA medicines for the treatment of prevalent chronic neurological disorders. Cyllene Tx is currently executing a Phase 1b/2a study in the US with its lead DNA medicine candidate, EG110A, in patients with neurogenic detrusor overactivity (NDO or neurogenic bladder)-related urinary incontinence. This is the first human study with nrHSV vectors targeting sensory neuron-based diseases. EG110A is a differentiated DNA medicine designed to selectively inhibit the activity of calcitonin gene-related peptide-positive (CGRP+) sensory neurons that drive bladder overactivity while preserving normal bladder function. It is being developed to address multiple severe bladder diseases, including overactive bladder (OAB) with urinary incontinence and interstitial cystitis (IC). In September 2026, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation for EG110A in NDO with urinary incontinence, building on the Fast Track designation for EG110A granted in September 2025. The company’s differentiated HERMES (Herpes-based Modular Expression System) platform utilizes non-replicative herpes simplex virus type 1 (nrHSV-1) vectors engineered to deliver site-specific long-lasting gene therapies directly to target neurons while avoiding systemic exposure to treat prevalent diseases of the peripheral and central nervous system.

For more information      www.cyllene-tx.com        www.linkedin.com/company/cyllene-tx

Contacts:

Company: Cyllene Therapeutics
Philippe Chambon, MD, PhD
Co-Founder, Chairman and CEO
pchambon@cyllene-tx.com

Global Media Relations
Sophie Baumont
Rose Piquante Consulting
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