Title of project

Dynamic crosslinked hydrogel microbeads for once-monthly subcutaneous peptide delivery

Abstract

Parenteral delivery is the most prevalent route-of-administration for biologics but high dose frequency, i.e. once-daily to once-weekly, for most products limits patient adherence. This project seeks to establish a novel hydrogel microbead sustained release technology to decrease dosing frequency of biologics to once-monthly or longer. This will provide patients superior treatment options by reducing dosing frequency and improving compliance. In addition to enabling the commercialization of short half-life biologics currently not marketable due to high dosing frequency requirement. This platform would allow Novo Nordisk A/S to build on their leadership in the injectable biologics space. The objective of the project is to develop an injectable subcutaneous sustained release platform with administration frequency in excess of once monthly and no injection site reactions. The project will leverage dynamic crosslinking of modified hydrogel polymers to create microbeads that encapsulate the drug, while being injectable from common autoinjectors. Unlike current technology, hydrogels don’t require organic solvents/oils or hydrophobic polymers that lead to injection site reactions and can be based on naturally occurring, biocompatible polymers currently used for cosmetic filler applications. The success criteria would be in ivo proof-of-concept in rats showing a once-monthly or longer subcutaneous PK profile (zero-order) of semaglutide (acetylated peptide) from the hydrogel microbeads; with acceptable burst release (<5% of dose) and no injection site reactions, i.e. immunogenic response. The formulation should further be compatible with standard autoinjection devices and needles without the need for additional handling (reconstitution or other). Thus, secondary success criteria will thus include shelf-life stability (chemical and colloidal) and injectability through needle gauge >30.