Groningen, December 1, 2021 — InnoCore Pharmaceuticals, today announced that it has received funding from the European Regional Development Fund to advance its AndroSphere™ development program in collaboration with its partner PolyVation. AndroSphere is a long acting injectable dosage form of recombinant human chorionic gonadotropin (rhCG) for the treatment of hypogonadotropic hypogonadism (HH), the main cause for "low testosterone" in men. In this joint effort, InnoCore and PolyVation aim to transform the treatment of HH by bringing Androsphere to patients.
HH is currently treated with testosterone replacement therapy, which can lead to testicular atrophy and infertility. Treatment with hCG, a natural gonadotropin that stimulates the production of testosterone, offers a regulatory approved alternative without these side effects, but suffers from low prescription and poor therapy compliance due to the need for multiple injections a week. AndroSphere, which is based on InnoCore’s proprietary SynBiosys® extended release microsphere technology and designed as a once monthly injection of hCG, provides a clinically superior and patient-friendly therapy by eliminating the need for frequent injections.
With the financial support of the European Regional Development Fund, InnCore Pharmaceuticals and PolyVation will advance the development of Androsphere and test its safety and efficicacy in a 'First-in-Man' phase 1 clinical trial. Main objectives include the scale-up of the manufacture of AndroSphere extended release hCG microspheres and the (GMP) manufacturing of pre-clinical and clinical supplies of Androsphere for GLP toxicology studies and the phase 1 clinical trial.
This milestone represents a significant advancement in the pursuit of enhanced treatments for hypogonadotropic hypogonadism. With a focus on patient convenience, reduced side effects, and improved long-term health outcomes, AndroSphere holds great promise for men with HH.
With this project, InnoCore Pharmaceuticals reaffirms its commitment to leverage its expertise in long-acting injectables and to contribute to the development of innovative healthcare solutions.
About InnoCore Pharmaceuticals:
InnoCore Pharmaceuticals is a pharmaceutical drug delivery and development company focused on the development and clinical manufacturing of injectable sustained release drug delivery products for the treatment of chronic and site-specific diseases. Utilizing its proprietary SynBiosys® and InGellTM biodegradable polymeric drug delivery platforms, InnoCore develops long-acting injectable depots in the form of microparticles, implants and gels for precisely controlled delivery of therapeutic compounds, including small molecules, peptides and proteins. Over the years, InnoCore's versatile drug delivery platforms have shown their safety and effectiveness in several pre-clinical and clinical trials. Since its inception in 2004, InnoCore has successfully established partnerships with biomedical, biotech and pharmaceutical companies. In 2013, the first product with InnoCore's SynBiosys® drug delivery technology incorporated received regulatory approval and is now available in the market. InnoCore Pharmaceuticals is privately owned and located in Groningen, The Netherlands. For more information visit www.innocorepharma.com
About PolyVation:
PolyVation is a trusted partner in polymer development, synthesis, and manufacturing for advanced biomedical and pharmaceutical applications. They provide polymer development, custom synthesis, scale-up, and GMP manufacturing services for customers developing advanced biomedical and pharmaceutical products. All manufacturing operations at PolyVation adhere to EU and FDA GMP industry guidelines. For more information visit www.polyvation.com.
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