Ceviginate (CVGN8) Hydrogel for Regeneration of Salivary Glands
Overview
Hydronovo is developing an injectable hydrogel-based neuromimetic therapy to regenerate damaged salivary gland tissue. This drug-device combination treatment aims to address xerostomia in patients suffering from a wide range of complications, including side effects of radiation therapy for Head and Neck Cancer as well as autoimmune diseases such as Sjögren’s Syndrome. With xerostomia affecting over 1 in 5 people globally, we aim to reduce oral health complications in these patients and improve their quality of life.
The Issue
Xerostomia, or chronic dry mouth, occurs when the salivary glands fail to produce sufficient saliva due to irreversible gland degeneration. This condition severely diminishes quality of life, causing pain, difficulty speaking and eating, sleep disruption, and other oro-digestive complications. Moreover, it leads to a wide range of effects, including dental decay and oral infections. Current treatments offer temporary symptom relief without restoring gland function. There is a critical unmet need for therapies that address the root cause of this condition, particularly for Head and Neck Cancer patients who develop severe, irreversible xerostomia following radiation therapy.
Approach
Hydronovo is developing Ceviginate (CVGN8), a patented, first-of-its-kind neuromimetic hydrogel that stimulates stem cell regeneration to restore natural salivary gland function. Importantly, this injectable therapy treats the issue locally to avoid the systemic side effects of oral medications and deliver long lasting relief.
MTM Student Engagement
MTM students bring cross-disciplinary expertise to support Hydronovo across critical areas: 1) GMP manufacturing development, 2) GLP nonclinical safety and toxicity studies, 3) clinical trial planning and business strategy, and 4) quality and regulatory support for IND application development. This collaboration between Hydronovo, UCSF, and MTM students accelerates the therapy’s path to clinical development and regulatory approval, bringing it closer to patients in need.
Project Brief
