Research shows Ampion mimics anti-inflammatory effects of steroids but without adverse effects

Tuesday April 20, 2021 0 comments Tags: Englewood, Ampio Pharmaceuticals, Ampion, Dr. David Bar-Or, Michael Macaluso

ENGLEWOOD -- Ampio Pharmaceuticals (NYSE American: AMPE) announced findings of pre-clinical research demonstrating Ampio's lead drug candidate, Ampion, provides some of the same anti-inflammatory effects as the steroid dexamethasone but without the significant adverse events associated with steroids. 

"Steroids such as dexamethasone are globally immunosuppressive, to both innate and adaptive immune systems, with effects that are beneficial in the short term and often harmful long-term," said David Bar-Or, director and founder of Ampio Pharmaceuticals.

"Our research looked at the gene-level interactions of both Ampion and dexamethasone in immunostimulated peripheral blood monocytes, or PBMCs and it became clear that Ampion regulated some of the same inflammation-associated genes as dexamethasone, though through disparate mechanisms of action. 

“This may explain Ampion's ability to mimic the anti-inflammatory effects of steroids without causing similar adverse effects."

"The coronavirus pandemic has highlighted the critical need for medical innovation,” said Michael Macaluso, Ampio president and CEO. 

“The potential availability of an anti-inflammatory therapy that provides many of the same benefits of dexamethasone without the similar adverse effects of long-term use would be a boon for patients suffering from debilitating and often life-threatening inflammatory disease."

The research highlighted key similarities and differences between Ampion and dexamethasone.

Similarities between Ampion and Dexamethasone

In the three different immunostimulation conditions used to evaluate Ampion's effect on PBMCs, Ampion regulated 102 of the same transcripts as dexamethasone according to RNA sequencing and differential gene expression analysis performed with Ingenuity Pathway Analysis (IPA) software from QIAGEN Digital Insights.

Further, overall IPA modeling predicted significantly similar regulation of downstream molecules by dexamethasone and Ampion based on directionally correlated transcripts. A comparison showed that, in each immunostimulatory condition, transcripts regulated by Ampion significantly overlapped with transcripts regulated by dexamethasone.

"Ampion acts as an anti-inflammatory drug with some important overlapping effects also provided by dexamethasone," said Bar-Or.

However, there were some significant differences seen between Ampion and dexamethasone. Based on IPA computational modeling, there were 30 transcripts where Ampion's activity was different from known regulation by dexamethasone – up regulating when dexamethasone was down, or vice versa – in at least one of the treatment conditions. 

Dexamethasone also targets a wide range of molecules that are not regulated by Ampion.

"These observations may help to explain, in addition to the different modes of action of the two drugs, why patients treated with Ampion do not suffer the same adverse effects as those treated with dexamethasone," said Bar-Or.

"In essence, this evidence suggests that Ampion is an anti-inflammatory drug with some important overlapping effects provided by dexamethasone but without the significant adverse events associated with steroids."