Microbiome startup AOBiome first tapped Veristat to help run a phase 2 study that tests its ammonia-oxidizing bacteria for the treatment of hypertension, and after Veristat finished enrollment earlier than expected, AOBiome decided to extend the collaboration.
The study was launched last December, and AOBiome announced completion of enrollment of all 116 individuals mid-April. At that time, AOBiome President Todd Krueger attributed the fast advancement to “an effective patient recruitment campaign conveying the advantages of topical therapeutic application.”
Under the “preferred provider agreement,” Veristat will continue to provide clinical research services to AOBiome’s ongoing studies as well as future ones.
These services include strategic consulting, clinical monitoring, clinical data management, biostatistical analysis, SAS programming, clinical protocol and study report writing, project management, and preparation of materials for submission to regulatory authorities.
AOBiome President Todd Krueger said in a statement that he was impressed with “the strength and breadth of therapeutic experience” of the Verstat team.
AOBiome’s product, live bacteria dubbed B244, produce nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. The company first examined it as an acne treatment, but while monitoring participants’ blood pressure as a safety endpoint, the company found that B244, when given at the highest trial dose, could reduce blood pressure at a statistically significant level. That finding provided insight for a new study in high blood pressure.
Veristat currently has five offices, including one it just opened in February in the Research Triangle Park in North Carolina. Besides two other U.S. locations in Massachusetts and the Bay Area, the CRO also operates from one in Montreal and one in Scotland, the U.K.