N4 Pharma Advances Novel Delivery Systems Toward Commercialisation
N4 Pharma, a pre-clinical stage specialist pharmaceutical company, has achieved progress toward the commercialisation of its innovative delivery systems, Nuvec® and LipTide®. This advancement follows the company's recent acquisition of a controlling interest in Nanogenics Limited, a developer of a unique lipid and peptide-based delivery system, LipTide®, which is being used in the formulation of a novel siRNA product, ECP105, in the ophthalmology market.
Advancements in Ophthalmology with ECP105
ECP105, a novel development for the post-surgical treatment of glaucoma, contains a proprietary siRNA sequence designed to silence the fibrotic gene MRTF-B, implicated in fibrosis of the liver, lung, and crucially, post-surgical glaucoma treatment sites. This novel approach offers hope to glaucoma patients who have not responded to medication and require surgery, which often leads to fibrosis and potential failure of the procedure. Unlike the current off-label use of toxic chemotherapy drugs like Mitomycin C, ECP105 can be administered repeatedly without cytotoxic side effects, a feature proven in initial in-vivo studies.
Nuvec®: A Novel Delivery System for Cancer, Gene Therapy, and Vaccines
Parallel to LipTide®'s progress, N4 Pharma's Nuvec® continues to show promise in pre-clinical research. Nuvec®, a novel silica nanoparticle delivery system, is being explored for its potential in cancer treatments, gene therapy, and vaccines. Recent studies highlight Nuvec's ability to bind multiple siRNAs, targeting cancer progression pathways, thus enhancing the efficacy of cancer treatments. Additionally, through collaboration with the University of Queensland, Nuvec's potential as an oral delivery system for oligonucleotides, including DNA and RNA, has been confirmed in vivo.
Engaging Regulatory Bodies and Future Directions
As these novel delivery systems advance, N4 Pharma is poised to engage in discussions with regulatory authorities such as the FDA and MHRA to approve further studies, including GLP toxicity studies and first-in-human clinical trials. With ongoing pre-clinical research and updates expected in 2024, the company remains at the forefront of non-viral, non-lipid delivery system development.
Nigel Theobald, CEO of N4 Pharma, expressed optimism about the company's direction, stating, "Non-viral, non-lipid delivery systems are in high demand in the exciting gene therapy and oncology spaces, and we now have two such delivery systems. Nuvec continues to show its versatility as a novel delivery system and with LipTide we are developing our first commercial product which we are aiming to take into phase 1 clinical trials."
