US-based clinical stage biopharmaceutical firm Cellceutix has started treating the first patient in its Phase IIb clinical trial of Brilacidin in patients with acute bacterial skin and skin structure infection (ABSSSI).
Brilacidin is the lead compound in a new class of immunomodulatory antimicrobials called defensin-mimetics.
In the trial, three different dosing regimens of Brilacidin including two single-dose regimens and one three-day regimen will be compared with a standard seven-day regimen of daptomycin, a drug marketed in the US by Cubist Pharmaceuticals under the brand name Cubicin.
According to the company, this is an important milestone as there are currently no US Food and Drug Administration-approved drugs that have a dosing regimen of less than seven days in duration.
If the data from Phase IIb clinical trial is positive, the company intends to use it for dose selection in an upcoming Phase III programme.
Cellceutix chief executive officer Leo Ehrlich said: "Patients are now being treated with Brilacidin at one clinical site and we anticipate that all four US sites in the trial will be up and running within one week.
"As the trial progresses, we expect that approximately 40 patients will be enrolled each month in the 200-patient study."
The company said that defensin-mimetic antibiotics are modelled after host defense proteins, which are the frontline of defence in the human immune system.
Brilacidin kills bacteria in the same manner as the human immune system, which help in reducing the risk of bacterial resistance.
The unique class of antimicrobial chemistry provides several other drug development opportunities for the company, such as treatment of bacterial infections of the eye and ear, as well as the prevention and treatment of oral mucositis in cancer patients.
Cellceutix is focused in the development of new therapies in oncology, dermatology and antibiotic applications.
Image: Brilacidin has the potential to be a single-dose therapy or a dosing regimen for multi-drug resistant bacteria. Photo: courtesy of renjith krishnan/freedigitalphotos.net.