Allegro’s osteoarthritis injectable shock absorbing gel demonstrates preclinical safety

• Clean systemic toxicity profile and no local side-effects following injection
• Tiny shock absorbing microparticles support and enhance synovial fluid
• Designed as potential first-in-class disease-modifying treatment
• Allegro to start pivotal clinical trials in osteoarthritis patients in 2025.

11 December 2024 -- Liege, Belgium -- Allegro NV, a biomedical company developing transformative nanotechnology-based devices for degenerative joint disease, today announced that its injectable microparticle gel, hydrocelin, has demonstrated favorable safety in two preclinical studies. The gel contains cross-linked microparticles that act as tiny shock absorbers in the synovial fluid. This reduces the force on sensitive nerve endings to provide immediate pain relief and starts to protect cartilage. Allegro intends to advance hydrocelin into multi-center pivotal clinical studies in osteoarthritis patients in 2025.

“Effective disease-modifying treatments for osteoarthritis are urgently needed as our population ages, as well as for athletes who are looking for alternative to invasive surgical procedures. These preclinical safety results for hydrocelin are encouraging and we plan to release additional in vivo safety and efficacy data over the coming months as we work to initiate the first clinical trials in humans next year,” said Lucas Decuypere, CEO of Allegro. “We believe hydrocelin possesses the necessary attributes to offer osteoarthritis patients pain relief and potentially protect joints and restore mobility.”

In the first preclinical safety study, hydrocelin was injected in knee joints of mice, while a phosphate-buffered saline solution was used as negative control. The mice were observed daily for behavioral and physical changes and monitored for clinical effects over 4 weeks; a histological analysis of the treated joints was performed at the end of the study. In a second acute systemic toxicity study, half of subjects received an intraperitoneal injection of hydrocelin, while the other half received sodium chloride as control, and were observed for 72 hours. The data showed no negative observations across a wide range of indicators, including overall behavior, gait, knee stiffness, body weight, fur condition, histological properties of the joint, and mortality.

About hydrocelin

Hydrocelin is an injectable microparticle hydrogel designed as a potential disease-modifying treatment for osteoarthritis. The biodegradable gel is an inert biocomposite, which confers unique mechanical properties and naturally self-reassembles. Forming a porous cell-friendly 3D scaffolding structure, the cross-linked microparticles act as tiny shock absorbers in the synovial fluid, even under demanding conditions. By restoring elasticity, hydrocelin enhances impact absorption and optimizes load distribution. This reduces the force on the sensitive nerve endings, providing immediate pain relief, protecting cartilage, and promoting joint homeostasis. The treatment in many ways is comparable to surgery with a joint distraction system, but minimally invasive.

About Allegro NV
Allegro is a private biomedical company developing transformative treatments for degenerative joint diseases based on its proprietary nanotechnology platform, INTRICATE. The company’s lead product candidate, hydrocelin, is a potential first-in-class, disease-modifying candidate for the treatment of osteoarthritis. Allegro is preparing hydrocelin for clinical studies in humans scheduled for 2025, and for a commercial launch in 2027. For more information please visit www.allegro.bio.