Ampio Pharmaceuticals has announced results of a randomized, double-blinded study of its intranasal Ampion, a biologic anti-inflammatory, for the treatment of nasal inflammation. According to the company, Ampion “is naturally produced by humans in response to injury and is present in commercial human serum albumin (HSA) preparations.” Ampio is also developing oral and injectable forms of the drug.
The study, which was conducted at Centers for Allergy and Asthma in Denver, involved 20 patients who received either intranasal Ampion or saline and found statistically significant improvement in total nasal symptom scores for Ampion compared to placebo in moderately symptomatic patients.
Ampio Chief Regulatory Officer Vaughan Clift commented, “This trial is an important clinical milestone for the company as it is the first time that Ampion was administered as a stand-alone treatment for an inflammatory condition in humans and was well tolerated with no reported treatment related adverse events. This study expands the investigation of the anti-inflammatory mechanism of action for Ampion in our Ampion-in-Knee (AIK) trial conducted in Australia as reported on October 26, 2011. This initial AIK study required the addition of a “standard of care” steroid in each arm as it was the first use of Ampion in humans. The absence of any adverse events in the initial AIK study provided the basis for IRB approval of the present intranasal trial in the USA as well as for the direct intra-articular comparison of Ampion to steroid in an expanded osteoarthritis of the knee trial in Australia, the results of which are expected early next year.”
Clift indicated that the Ampio will use data from both trials to choose whether to pursue intranasal Ampion or another dosage form in an upcoming clinical trial in the US. According to Ampio’s website, the company also considers Ampion a potential treatment for inflammatory respiratory disease.
Read the Ampio press release.
