US-based biopharmaceutical company Cellceutix has begun screening patients and administrating them with Brilacidin, marking the initiation of Phase II Proof of Concept trial designed to treat ulcerative proctitis.
Brilacidin is a new class of antibiotics called defensin-mimetics that replicate the body's innate host-defence response.
The Proof of Concept trial is designed to evaluate the ability of Brilacidin to cure ulcerative proctitis.
The trial will enrol 18 adult patients who will be administered with Brilacidin through retention enema at three different concentrations once daily at bedtime for a duration of six weeks.
It is being conducted in an overseas hospital / clinic setting and Brilacidin will be administered with water.
Further studies will witness the administration of a foam formulation of Brilacidin.
On the last day of the treatment, endoscopy will be done of the rectum and mucosa, up to 40cm from the anal verge.
The endoscopic determinations will be photographed and videotaped for an eventual evaluation by a gastroenterologist who is blinded to the day of on-treatment endoscopy and the dosage of Brilacidin used.
Ulcerative proctitis is a mucosal inflammatory disease characterised by rectum inflammation, redness, and ulcerations of the lining of the rectum.
Brilacidin, with its anti-inflammatory properties, terminates bacteria in a quick and efficient way, penetrating bacterial cell wall membranes.
Its defence mechanism weakens the resistance of the bacteria.
Brilacidin also functions as an immunomodulatory capacity, reducing inflammation and promoting healing.
If successful, the trial will secure warranty for Brilacidin in treating ulcerative colitis and Crohn's disease.