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Allegro reports positive safety data for its injectable osteoarthritis treatment in three preclinical studies

  • Hydrocelin is potentially a first-in-class disease-modifying injectable treatment for osteoarthritis
  • Pivotal clinical trial in osteoarthritis patients on track to start in 2025

Liege, Belgium – 4 March 2025 (08:30 CET) – Allegro NV, a biomedical company developing a transformative nanotechnology-based treatment for degenerative joint disease, announced today that hydrocelin (ALG-001), its lead injectable microparticle hydrogel, has been found safe in three preclinical studies. The studies found no signs of pyrogenicity, irritation or delayed sensitization in the test groups, strengthening hydrocelin’s safety profile after two earlier preclinical studies announced in December. Allegro intends to launch a multi-center pivotal trial in osteoarthritis patients in Belgium later this year.

“These preclinical results are an important step in fulfilling Allegro’s mission of giving back mobility to the millions of people suffering from osteoarthritis around the world. Allegro’s hydrocelin injection, which we expect will need to be administered once a year, is designed to provide immediate pain relief for patients and deliver disease-modifying therapeutic benefit. With an ageing population, the need for a lasting solution for osteoarthritis will continue to grow in importance,” said Lucas Decuypere, Chief Executive Officer at Allegro.

Hydrocelin contains cross-linked microparticles acting as tiny shock absorbers in the synovial fluid of the joints. Restoring the shock-absorbing capacity of the synovial fluid reduces the force on sensitive nerve endings, providing immediate pain relief, and potentially protecting cartilage. In the preclinical studies, Allegro demonstrated hydrocelin was safe to use in three important aspects: the potential to cause irritation following intracutaneous injection, pyrogenicity and delayed sensitization.

About hydrocelin (ALG-001)
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, while being 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 (ALG-001) is a potential first-in-class, disease-modifying candidate for the treatment of osteoarthritis. Allegro is preparing hydrocelin for clinical studies in humans in 2025, and for a commercial launch in 2027.

For more information please visit www.allegro.bio.



For further information please contact:

Allegro NV
Lucas Decuypere
Chief Executive Officer
info@allegro.bio


 

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Important information
The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

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