BIONDD(TM) for Oral Delivery of Biologics – Effective Gastric Mucosal Delivery of Macromolecules - Go BIONDD
Karsten Lindhardt
CEO, Biograil
Biograil has developed the proprietary technology BIONDD(TM) [BEYOND] for effective oral delivery of biologics such as peptides, oligonucleotides, antibodies, and proteins that must be injected today. The delivery device fits into a 00-sized or 0-sized capsule and will be made of fully biocompostable and biocompatible material to avoid disposal issues as associated with disposable syringes.
Oral delivery is by far the most preferred administration route for pharmaceuticals, but limited absorption of larger molecules such as biologics has been a major challenge. A new group of novel technologies delivering active substances into the wall instead of in the lumen of the GI tract, has shown very promising results with relative bioavailabilities of 70-200% compared to subcutaneous injection.
The BIONDD(TM) capsule is swallowed and, when exposed to liquids in the stomach, triggers a mechanism for safe insertion of active substance into the stomach wall. This allows for effective distribution of biomacromolecules to the blood stream and circulation which today would need to be injected.
Karsten has more than 20 years of experience from the pharmaceutical industry (the last 12 as a C-level executive). He is the CEO and founder of Biograil developing a drug delivery device BIONDD™ for effective oral delivery of biomacromolecules. The small device has been developed to fit into a 0 or 00 capsule and making it easy-to-swallow for patients. Data have been generated suggesting that the relative bioavailability can be much higher for BIONDD™ than for subcutaneous delivery of biological molecules such as antibodies. Karsten started to explore this technology with his team when he was CSO at Egalet, where he was also part of the executive management team making a successful IPO on NASDAQ NYC. Karsten and the team were responsible for the world’s first injection molded oral product, Arymo ER, to get FDA approval. Through his career Karsten has worked in various biotech and pharma companies (Biograil, Egalet, Curalogic, Prosidion, Ferring and Novo Nordisk) and has been involved in API upscaling, formulation development, pre-clinical screening and toxicology, phase 1, 2 and 3 clinical development, NDA, approval and launch, and business development pitching various technologies with great success. He founded an NGO named Category 1 focus group, which works on behalf of the pharmaceutical industry to improve methodologies for evaluating abuse-deterrent technologies and has participated in several FDA hearings as a representative for the industry.