Ghana FDA grants final approval to Vanessa Biotech for Phase II clinical trials for VR-AD-1005, a novel antidiarrheal investigational drug, for treatment of severe diarrhea of cholera.
Vanessa Biotech, the Hamden, Conn. based global biomedical company dedicated to making an impact on healthcare markets, has been granted regulatory approval from the Ghana FDA to conduct Phase II clinical trials for VR-AD-1005, a novel antidiarrheal investigational drug.
The Phase 2 study will be conducted during the current rainy season by the University of Ghana’s research team lead by Prof. Ernest Kenu as Principal Investigator. The team had its kickoff meeting on August 12, 2021, and is now in full preparation mode for the trial to begin recruiting patients.
The drug will be studied for the innovative treatment of severe diarrhea of cholera, heralding a pipeline of drugs developed in hopes of neutralizing the lethal diarrhea of cholera as well as rotaviral diarrhea and traveler’s diarrhea.VR-AD-1005 is intended to work by reducing the volume of liquid stool produced by the intestine when suffering from the diarrheal pathogen. The drug works within the intestine without affecting its motility and does not induce constipation. If successful—unlike other antidiarrheal medications—VR-AD-1005 will be the first symptomatic medication to treat severe secretory diarrhea.
“The company is currently amid its first external capital Raise” commented CFO Don Janezic, “And beginning this Phase 2 trial is a significant milestone in the company’s quest to be major player in the anti-diarrheal space.”
* These claims are based on preclinical studies and observed results in clinical trials to date. As clinical trials have not been completed, there can be no definitive proof these claims will ultimately be proven to be factual.