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Alenura is a unique, combination product of alkalinised lidocaine and the glycosaminoglycan heparin. Alkalinised lidocaine penetrates the transitional epithelial cell layer and provides immediate pain relief.
The collaboration aims to facilitate Chemistry, Manufacturing, and Control documentation for Lipella's drug candidate LP-10 (liposomal tacrolimus), aimed at treating hemorrhagic cystitis. LP-10 has been granted Orphan Drug Designation by the FDA.
Interim 12-week analysis from an ongoing Phase 2a trial of an investigational novel gene therapy product URO-902 (hMaxi-K), showed clinically relevant improvement in the common symptoms of overactive bladder (OAB) compared to placebo.
Interim 12-week analysis from a Phase 2a trial of the potential gene therapy, URO-902, in women with overactive bladder and urge urinary incontinence will be featured in a late-breaker presentation during plenary session.
URO-902 showed a clinically meaningful and statistically significant effect on a number of relevant outcome measures in OAB including number of micturitions, urgency episodes, and quality of life indicators compared to placebo, 12 weeks post-administration.
Under the terms of the agreement, Vaneltix will be responsible for the further development, manufacturing, regulatory affairs and commercialisation of AlenuraTM in collaboration with Hyloris.
A multi-site, prospective, open-label, dose-escalation clinical trial assessing the safety and efficacy of LP-10 (liposomal tacrolimus) is now open for recruitment at several sites.
Phase 2 APOLLO clinical trial of a RTGel hydrogel formulation in combination with BOTOX® intravesical instillation in patients with overactive bladder (OAB) and urinary incontinence did not meet the primary endpoint of improvement of overactive bladder symptoms.
In the trials, URO-902 was well tolerated and the administration via direct injection procedure demonstrated statistically significant improvement in OAB symptoms.