The clinical study was conducted by an independent third party, monitoring the tolerance and toxicity of its proprietary BioLexa Platform on minipigs. There were two phases with the first phase of the study being completed in September of 2019.
Phase I In-Life Dose Escalation Study
- Searching for the maximum feasible volume.
- Initiated at 0.5 ml/kg, and then increased to 1.0 mg/kg, 1.5 mg/kg, and 2.0 mg/ kg once daily approximately every 18-24 hours.
- Found no visible lesions on any of trial patients.
“Management is pleased that our BioLexa Platform continues to demonstrate an impressive safety profile during its testing phase,” said, Mr. Robb Knie, Chief Executive Officer of Hoth Therapeutics. “We believe this therapeutic candidate has the potential to provide significant benefits to people afflicted by Atopic Dermatitis. Going forward, we are focused on expanding our clinical efforts into later stage trials.”
This stage of the toxicity study was designed to determine dose-limiting adverse events and to define the maximum tolerated dose of the BioLexa Platform. The BioLexa Platform is a proprietary, patented therapeutic designed for the treatment of atopic dermatitis.
Source: Company Press Release