Dicerna Announces FDA Acceptance of Lilly’s Investigational New Drug (IND) Application for LY3819469
May 27, 2021
– Second GalXC™ RNAi Investigational New Drug (IND) Application Filed by Lilly Under Companies’ Global Research Collaboration and Licensing Agreement –
“This milestone marks the second IND generated through our productive collaboration with Lilly,” said
The IND filing for LY3819469 is the second development milestone achieved under a 2018 global licensing and research collaboration between Dicerna and Lilly focused on the discovery, development and commercialization of potential new therapies for cardiometabolic and neurodegenerative diseases and pain. This investigational cardiometabolic therapy and future therapies to emerge from the two companies’ collaboration leverage Dicerna's proprietary GalXC RNAi technology platform.
Under the agreement, Dicerna is eligible to receive up to
About RNAi and Dicerna’s GalXC™ RNAi Platform Technologies
Ribonucleic acid interference, or RNAi, provides a unique advantage to other disease inhibitor technologies, like small-molecule pharmaceuticals or monoclonal antibodies. Instead of targeting proteins after they have been produced and released, RNAi silences the genes themselves via the specific destruction of the messenger RNA (mRNA) made from the gene. Rather than seeking to inhibit a protein, the RNAi approach can prevent a disease-causing protein’s creation, directly impacting disease manifestation.
Dicerna’s proprietary GalXC™ RNAi platform aims to advance the development of next-generation RNAi-based therapies. Investigational therapeutics developed using our flagship GalXC technology utilize a proprietary N-acetyl-D-galactosamine (GalNAc)-mediated structure of double-stranded RNA molecules that are designed to bind specifically to receptors on liver cells, leading to selective hepatocyte internalization and access to the RNAi machinery within the cells. Dicerna is continuously innovating and exploring new applications of RNAi technology beyond GalNAc-mediated delivery to the liver, including alternative RNA structures and fully synthetic ligands that target other tissues and enable new therapeutic applications, referred to as GalXC-Plus™.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Examples of forward-looking statements include, among others, statements we make regarding the collaboration agreement with Lilly and the therapeutic potential of LY3819469 and other development candidates under the agreement with Lilly. The process by which investigational therapies could potentially lead to an approved product is long and subject to highly significant risks. Applicable risks and uncertainties include those relating to Dicerna’s clinical research and other risks identified under the heading "Risk Factors" included in the Company’s most recent filings on Forms 10-K and 10-Q and in other future filings with the
GalXC™ and GalXC-Plus™ are trademarks of