Hyloris enrols first patient in four-arm clinical trial
James Spargo | June 22, 2023 | News story | Research and Development | Genito-Urinary system, Hyloris, bladder pain, clinical trial, cystitis
Belgian specialty biopharmaceutical company Hyloris has announced that it has enrolled the first patient in its four-arm interstitial cystitis/bladder pain syndrome (IC/BPS) clinical trial.
The phase 2 study, comprising 120 patients across multiple sites in the US, will test Alenura, a clinical-stage instillation product candidate, compared to its two individual components, heparin and lidocaine, and a placebo. Heparin is a glycoso-amino-glycan (GAG), which is a component of bladder mucous membranes, and lidocaine is a well-established anaesthetic. Due to its dual mode-of-action, Alenura can provide pain relief while augmenting the mucous layer of the bladder, making it more effective in terms of pain management, urgency response and improvement of symptoms over placebo, heparin and lidocaine individually.
The primary endpoint of the trial will be to evaluate the change in Sum of bladder Pain Intensity Differences from baseline to 12 hours after the administration of Alenura compared to its individual active components and placebo. This is determined by using the 11-point numerical rating scale (NRS) for bladder pain.
Stijn Van Rompay, CEO of Hyloris, commented: “Currently there are no drug products specifically approved to treat acute bladder pain in patients with IC/BPS. Alenuraholds the promise of a ready-to-use solution to be administered by physicians. We are highly motivated to offer relief to these patients by improving the symptoms disrupting their daily lives. This ambitious phase 2 programme includes additional clinical trials, potentially reducing time and number of patients needed in phase 3 trials, in order to help patients waiting for an efficient treatment sooner rather than later.”
James Spargo
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