LONDON (Alliance News) - 4d Pharma PLC Tuesday said two of its products are set to enter clinical studies in the second quarter of 2015, following on from its Rosburix drug winning an orphan designation from the US drug watchdog.
The pharmaceutical firm said its Blautix treatment for irritable bowel syndrome (IBS) and its Thetanix drug for paediatric Crohn's disease (PCD) are set to enter clinical studies in the second quarter of 2015. The studies would focus on evaluating the safety and tolerability of the products.
In addition, 4d said some clinical effects of the treatments will be assessed in PCD patients for Thetanix, and in healthy volunteer subjects and a small number of symptomatic IBS patients for Blautix.
The news comes after the company said in August its Rosburix drug, a treatment for ulcerative colitis in paediatric patients, won orphan drug designation from the US Food and Drug Administration. Thetanix won the same designation in September 2013 for the treatment of PCD.
Regulators grant orphan designation to treatments under examination that are intended to treat rare diseases. For the US FDA, the status applies to treatments for disorders and diseases affecting fewer than 200,000 people in the country.
By Sam Unsted; samunsted@alliancenews.com; @SamUAtAlliance
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