BioWorld International Correspondent

A trio of Scandinavian firms is embarking on a project to investigate the potential of nasal delivery as a route for vaccine administration, drawing on support from a European Union program aimed at small and medium-sized enterprises.

Norwegian company OptiNose AS, of Oslo, has teamed with two Swedish partners, Eurocine AB, of Stockholm, and Diabact AB, of Uppsala, in a €1.7 million initiative, which has attracted 50 percent funding from the EU's Craft program for cooperative research projects.

That program is intended to allow companies facing similar technical challenges but with minimal in-house R&D capabilities to outsource specific research tasks to third parties. Companies eligible for funding must have fewer than 250 employees and either turnover of less than €40 million or a balance sheet valuation of less than €27 million.

This spring, the partners plan to conduct a Phase I/II clinical trial in Sweden of a nasal diphtheria/tetanus/pertussis vaccine. It will be comprised of two legs. It will test the efficacy of an adjuvant developed by Eurocine, and it will also involve a comparison between a novel nasal deposition device developed by OptiNose and traditional nasal sprays. Diabact is contributing its expertise in powder vaccine formulation to the undertaking.

OptiNose CEO Helena Kyttari Djupesland told BioWorld International the forthcoming study represents the company's first clinical trial of a device designed specifically for vaccine delivery. The Craft program, which runs for two years, also will fund preclinical studies of nasal vaccines for protection against influenza, tuberculosis and Hantavirus-causing renal disease.

OptiNose was founded in October 2000 by chairman and head of R&D, Per G. Djupesland, who is a specialist in otorhinolaryngology. He is the inventor of the OptiNose technology platform, which is designed to overcome the shortcomings of traditional nasal delivery devices. "The device can achieve improved deposition to larger parts of the nasal mucosa - shown in clinical studies, not yet published - and increase the deposition to the upper and posterior parts of the nasal passage," he said. The company aims to reduce adverse effects, such as irritation or bad taste, while minimizing deposition outside target regions.

It also is applying the concept to delivery of systemic and topical drugs. "We know that traditional sprays deposit in the front area of the nose," Djupesland said. "With our technology, nothing is inhaled in the lungs."

OptiNose closed NOK6.7 million (US$970,000) in funding in December from Andromeda Fund BV, part of the Entrepreneur Fund, of Amsterdam, the Netherlands.