Eager to find a formulation that will give Pfizer's inhalation device Exubera (insulin rDNA) a run for its money, Nastech is initiating a Phase I study to compare Exubera to its insulin nasal spray and to an approved injectable product.
The pharmacokinetic study is the first of many needed to select the formulation and determine the optimal insulin nasal spray dose that will be used to conduct subsequent safety and efficacy studies, as Nastech searches for the candidate that could beat Exubera.
With approximately 21m people suffering from diabetes in the US alone and branded insulin sales in the country reaching $1bn (€0.78bn) in the second quarter of 2006, Pfizer has said it expects Exubera to become a blockbuster, exceeding $1bn in annual sales.
Nastech has decided to take on Exubera with its rapid-acting intranasal insulin formulation, confident it can provide a needle-free alternative while avoiding possible pulmonary side effects or long term toxicity associated with the inhalation of insulin.
"This product candidate utilises Nastech's proprietary drug delivery technologies which have demonstrated the ability to safely and effectively deliver large molecules through a non-invasive, intranasal route of administration," said Nastech CEO Steven Quay.
"Nastech's insulin nasal spray could offer a patient- and physician-preferred form of administration that avoids an injection and the potential safety concerns of pulmonary delivery."
In the dose ranging study, subjects will receive a single subcutaneous injection of insulin, a single administration of Exubera and several different Nastech insulin nasal spray doses on separate days.
Pharmacokinetic and pharmacodynamic parameters will be evaluated, as well as tolerability of the insulin nasal spray doses.
"The convenience and privacy afforded by a device the size of a pack of gum also should promote patient compliance, which could in turn translate into better diabetes control and outcomes."
"We look forward to rapidly advancing this program and finding an appropriate marketing partner."
The formulation is being developed using Nastech's high-throughput human tissue culture screening process, a proprietary system for developing large molecule therapeutics that are delivered across the nasal mucosa.
It has been successful in the company's clinical studies for the nasal delivery of the peptide drugs PYY for obesity, PTH (parathyroid hormone) for osteoporosis, and the protein ß-interferon for multiple sclerosis.