Orexo Announces Results Confirming The Clinical Profile Of OX17 In Reflux Disease (GERD)

Main Category: Acid Reflux / GERD
Also Included In: GastroIntestinal / Gastroenterology
Article Date: 28 Mar 2008 - 6:00 PDT

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New clinical data from a phase II study confirms the competitive profile of Orexo's product OX17 in GERD patients, i.e. fast, effective and sustained inhibition of gastric acid production, a prerequisite for effective symptom relief in the patient. The result demonstrates the clinical potential of OX17 and is an important step in the development of a competitive product.

GERD, gastroesofageal reflux disease, is a common ailment in the Western world. Orexos product OX17 combines the advantages (rapid onset and sustained duration of effect) of two existing treatments and therefore has the potential to become an important alternative in the treatment of reflux disease. OX17 is a combination of two well-known active substances both inhibiting the secretion of gastric acid; a H2 receptor antagonist (famotidine) and a proton pump inhibitor (omeprazole).

In a controlled clinical trial with 59 GERD patients treated for 14 days, the anti-secretory effect of OX17 was compared to omeprazole and famotidine. The study was performed at Sahlgrenska university hospital in Gothenburg and Berzelius Clinical Research Center in Linköping, Sweden. The primary endpoint was fulfilled: OX17 significantly reduces the acid production compared to omeprazole day 1. The time with pH>4 the first 12 hours after dosing was on average 60% longer with OX17 compared to omeprazole. (p<0.05). After 14 days treatment, the time with gastric pH above 4 was twice as long as after treatment with famotidine. The patients need for rescue medication (antacids) during the 14 day study period was considerably lower for OX17 compared to both famotidine and omeprazole indicating good control of GERD symptoms.

"The results confirm that OX17 has a favorable and unique clinical profile for a drug intended for the treatment of GERD. This is an important strategic step in our OX17-project, which further increases the project's commercial value. In 2006, the combined market for H2 receptor antagonists and proton pump inhibitors amounted to some USD 27 bn", said Torbjörn Bjerke, President and CEO of Orexo.

About Orexo

Orexo is a specialty pharmaceutical company, focusing on development of new, patented drugs by combining well-documented substances with innovative technologies, and the development of new treatments for respiratory and inflammatory diseases.

Orexo has a broad and competitive late-stage product portfolio, including two marketed products, five products in clinical phase and two undergoing registration.

To date, Orexo have out-licensed the market rights for Rapinyl for the US, the EU and Japan markets, and signed a research collaboration with Boehringer Ingelheim regarding the development of a new class of drugs to treat pain and inflammation. Also, Orexo has established a Nordic sales force by entering into a joint venture with ProStrakan.

Orexo has head office in Uppsala and is listed on the OMX Nordic Exchange Stockholm, Small Cap (ticker: ORX).

http://www.orexo.com