Date: 2016-04-26
Type of
information: Submission of a clinical trial application
phase: 3
Announcement: submission of a clinical trial application
Company: Cellceutix (USA - MA) now Innovation Pharmaceuticals (USA - MA)
Product: brilacidin
Action
mechanism:
- antibiotic. Brilacidin is the first in a new class of immunomodulatory antibiotics known as Host Defense Protein (HDP) mimics. The intravenous formulation of Brilacidin has the potential to treat a variety of infections, including ABSSSI caused by drug-sensitive or drug-resistant strains of Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA), and by other Gram-positive bacteria.
- The FDA designated Brilacidin as a Qualified Infectious Disease Product (QIDP) under the GAIN Act in November, 2014.
Disease: acute bacterial skin and skin structure infections (ABSSSI)
Therapeutic
area: Infectious diseases
Country:
Trial
details:
Latest
news:
- • On February 26, 2016, Cellceutix announced that it has submitted a Special Protocol Assessment (SPA) request, along with a final protocol to FDA, for a phase 3 clinical trial of brilacidin, for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The title of the protocol submitted with the SPA request is: “A Phase 3, Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Brilacidin versus IV Vancomycin Followed by Optional PO Linezolid for the Treatment of Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)”.
• On January 14, 2016, Cellceutix announced that manufacturing, lyophilization and filling of vials is now complete in preparation for the planned Phase 3 trials of brilacidin for acute bacterial skin and skin structure (ABSSSI) infections caused by Gram-positive bacteria. The vials are now in the inspection and quality control (QC) stage.
- • On December 11, 2015, Cellceutix announced that laboratory testing of brilacidin has been completed for use in the planned Phase 3 study in Acute Bacterial Skin and Skin Structure Infections (ABSSSI). This lot of Brilacidin API (active pharmaceutical ingredient) has now passed rigorous quality control tests. In addition, development work on lyophilizing Brilacidin has been successfully completed. The engineering run has been completed and the production run is scheduled for this month. This will allow Brilacidin for ABSSSI to be stored at room temperature or under refrigeration, a significant advantage over freezing, as was required in the past. The Company is now completing all the necessary steps to move Brilacidin for ABSSSI into Phase 3, including working with vendors in selecting international sites for the planned study.
• On October 30, 2015, Cellceutix provided an update on brilacidin. Last year, the Company successfully completed a phase 2b study in patients with Acute Bacterial Skin and Skin Structure Infections (ABBBSI). There were there were no serious adverse events (SAEs) that were deemed by the principal investigator (PI) as related to study drug. Efficacy was high across all brilacidin treatment groups, including the two single-dose groups, and similar to daptomycin, the active comparator. Brilacidin received Qualified Infectious Disease Product (QIDP) designation under the GAIN Act in November 2014, and the Company had a positive End-of-Phase 2 Meeting with FDA in July 2015. Although phase 3 start up activities may take a little longer than usual for a new class of compounds, the Company remains on track in its preparations.
Is
general: Yes
