Biolipox reports rapid relief with NLA Nasal Spray in new clinical trial

Biolipox, a Swedish research-intensive pharmaceutical company in respiratory and inflammatory diseases, announced today that it has successfully completed a new clinical study, evaluating the time-to-onset of effect of its new antihistamine treatment, NLA Nasal Spray. The drug was shown to have an onset of effect within 5-10 minutes after intake. This follows the announcement in June 2004 that NLA Nasal Spray had reached the primary efficacy endpoint of a Phase IIa study in patients suffering from allergic rhinitis. These results strongly support the development of NLA Nasal Spray as on-demand treatment.

A single intranasal dose of either NLA Nasal Spray or placebo was given to twelve healthy volunteers in a double-blind, randomized and crossover order. To mimic an allergic reaction, histamine challenges were made at regular intervals after administration of the trial medication. The nasal lavages were thereafter analyzed for a specific protein that is increased after a histamine reaction. NLA Nasal Spray was found to reduce the protein content statistically significantly compared with placebo already at 5-10 minutes after intake. “These are quite impressive results”, says Associate Professor L. Greiff at the ENT Department of Lund University Hospital, Sweden, and principal investigator in the study. “No antihistamine drug has shown as rapid an onset of action as NLA Nasal Spray in this study. Patients with allergic rhinitis want fast-acting treatment and NLA Nasal Spray has the potential to offer what they are asking for.” About 25% of the population of the Western world suffers from allergic rhinitis, and the number is rising rapidly. However, rhinitis therapy today is not optimal. There is a need for rapid and significant clinical efficacy. “We are delighted by these results”, said Torbjörn Bjerke, President and CEO at Biolipox. “With our product we may be able to offer the rhinitis patient reliable on-demand treatment. Continuous treatment increases the risk of side-effects, but by taking the anti-allergy medicine only at the moment when symptoms appear, this risk is considerably reduced.” He continues, “Our goal is to develop a product which has a rapid onset of action and less side-effects. These results strengthen Biolipox’s confidence in NLA Nasal Spray as first line prescription therapy on the worldwide allergic market, a market with a value exceeding USD 6 billion.” Biolipox has an exclusive worldwide license to the NLA compound from NicOx S.A (Bloomberg: COX:FP, Reuters: NCOX.LN). For further information, please contact: Dr. Torbjörn Bjerke, President and CEO, Biolipox AB (publ) +46 (0) 708 66 19 90 mobile or + 46 (0)8 545 28 140 direct office E-mail: torbjorn.bjerke@biolipox.com For fact sheets, images and illustrations, please visit www.biolipox.com/press