Innovation Pharma obtains FDA guidance for Brilacidin Phase 3 program
Brilacidin oral rinse is supposedly being developed as part of FDA Fast Track designation for Oral Mucositis Reports confirm that Innovation Pharmaceuticals, a clinical stage biopharmaceutical company, has recently received End-of-Phase 2 meeting minutes from the US Food and Drug Administration (FDA), which would help to guide the planned Phase 3 program of the company for Brilacidin oral rinse. Apparently, the program is aimed at studying Brilacidin to reduce the incidence of Severe Oral Mucositis or SOM in neck and head cancer patients undergoing chemoradiation. Brilacidin oral rinse is supposedly being developed as part of FDA’s Fast Track designation for Oral Mucositis. In December 2018, when the EoP2 meeting was summoned, FDA and Innovation Pharmaceuticals agreed to a suitable Phase 3 development pathway of Brilacidin. FDA’s guidance now also aids to frame continuing discussions with the European Medicines Agency under the Scientific Advice process. The purpose of both these interactions is to safeguard proposed plans which meet regulatory needs for New Drug Application or Marketing Authorization Application filings, and eventually to get Brilacidin approved for Severe Oral Mucositis in HNC in both Europe and the United States. According to President and Chief Medical Officer of Innovation Pharmaceuticals, Arthur P. Bertolino, MD, PhD, MBA, Brilacidin oral rinse helps in reducing the incidence of SOM which signifies a potential future regimen for millions of neck and head cancer patients, where currently no approved drug exists. Dr. Bertolino added that moreover, the company hopes that Brilacidin will ultimately develop as a treatment for other indications where SOM is also considered as a recurrent side-effect of cancer therapies. Chief Executive Officer of Innovation Pharmaceuticals, Leo Ehrlich, said that treatment associated with SOM in cancer patients is an actual problem globally, which affects millions of patients with financial and physical ramifications. Ehrlich mentioned that presently, Innovation Pharmaceuticals is the only company advancing into late-stage trials with an oral drug candidate and positioned to meet this unmet requirement. The company is looking forward to initiating the planned Phase 3 program that adds value and credibility to the Brilacidin Franchise. Source Credit: https://www.globenewswire.com/news-release/2019/05/01/1813598/0/en/Innovation-Pharmaceuticals-Receives-FDA-End-of-Phase-2-Meeting-Minutes.html http://www.ipharminc.com/press-release/2019/5/1/innovation-pharmaceuticals-receives-fda-end-of-phase-2-meeting-minutes