Nemaura Pharma has successfully completed preclinical immunogenicity studies for two vaccines using its proprietary Micro-Patch injector technology. The investigators demonstrated an immune response for both the tetanus vaccine and the DTaP (diphtheria, tetanus, and pertussis) vaccine. “These are very encouraging results”, commented Dr Faz Chowdhury, CEO of Nemaura Pharma. “It is an important step towards a vaccine delivery system that is easy to manufacture and use and does not require a cold chain”.
The Micro-Patch system works by initially inserting a super-sharp stainless steel needle into the outer layer of the skin. This is immediately followed by the delivery of a solid dose formulation in pellet form. The needle then retracts completely, minimising the risk of stick injuries, and the solid dose formulation remains deposited in the skin. The preclinical study showed that the freeze drying process that converted the DTaP vaccine to pellet form did not lead to any loss of potency.
“Conventional vaccination systems can be tricky to deliver and administer, especially in low-income countries”, explained Dr Chowdhury. “If we can develop a system that eliminates the need for maintaining a cold-chain, and does not require any specialist training to use, we can spread the benefits of vaccination as widely as possible”. The Micro-Patch solid micro-dose skin delivery system is stable, readily administered, and has the potential to deliver high potency, low volume dosages. Disposal costs are low and the injector technology is presented in a single-use, unit dose. It is associated with minimal pain, something that can be particularly important in settings where there is hesitancy over vaccination.
Nemaura is honing industrial processes to manufacture pellets considerably smaller than those used in the preclinical studies, as well as exploring the technology’s potential for use with other molecules. “Based on the satisfactory results of the preclinical studies, we plan to move forward with clinical studies”, added Dr Chowdhury.
Details on the preclinical studies can be found at
http://www.ondrugdelivery.com/publications/65/Nemaura.pdf
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements.
Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Nemaura’s ongoing studies, including the safety and efficacy of Nemaura’s Micro-Patch system, the failure of future development and preliminary marketing efforts, Nemaura’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Nemaura and its partners’ ability to develop, market and sell the Micro-Patch System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its Micro-Patch System.
Nemaura undertakes no obligation to publicly update or revise any forward-looking statements.