Dear Innovation Pharmaceuticals Shareholders, I
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Posted On: 11/02/2018 8:47:28 AM
Dear Innovation Pharmaceuticals Shareholders,
Innovation Pharmaceuticals Submits End of Phase 2 "Briefing Package" to FDA.
Earlier this week, the company submitted the “briefing package” for our scheduled End-of-Phase 2 meeting to be held later this quarter with the FDA. This is an exciting milestone in the development of oral rinse Brilacidin for the treatment of Oral Mucositis.
A successful FDA meeting would be transformative for our company, opening up enormous potential for our shareholders and, more importantly, for patients who need such a treatment.
I wish to remind shareholders of the results achieved in the Phase 2 study with Brilacidin. In Head and Neck Cancer patients receiving cisplatin administered in a higher concentration (80-100 mg/m2), approximately every 21 days, oral rinse Brilacidin’s results were as follows:
In the Modified Intention-to-Treat population, 71.4% of patients receiving placebo developed severe Oral Mucositis, compared to 25.0% of patients receiving Brilacidin [mITT Population] (p=0.048).
In the Per Protocol population, 72.7% of patients receiving placebo developed severe Oral Mucositis, compared to 14.3% of patients receiving Brilacidin [PP Population] (p=0.025).
The stark difference between how our drug performed against placebo will be a focus of our FDA meeting and provides us with a high-degree of confidence in the treatment potential and commercial value of our asset. As we have shared previously, our research shows there is a significant market opportunity for treating Oral Mucositis in Head and Neck Cancer patients receiving chemoradiation, as there currently is no FDA-approved drug. Of course, there are no assurances stated or implied regarding successfully developing a drug, but if we are successful, we believe that earnings from a new, easy-to-use OM drug could be many multiples of our present market cap. This keeps us driving forward in executing on our business model and building shareholder value.
In our next corporate filing (10q), we will be updating shareholders on other ongoing business and clinical development priorities.
Innovation Pharmaceuticals Submits End of Phase 2 "Briefing Package" to FDA.
Earlier this week, the company submitted the “briefing package” for our scheduled End-of-Phase 2 meeting to be held later this quarter with the FDA. This is an exciting milestone in the development of oral rinse Brilacidin for the treatment of Oral Mucositis.
A successful FDA meeting would be transformative for our company, opening up enormous potential for our shareholders and, more importantly, for patients who need such a treatment.
I wish to remind shareholders of the results achieved in the Phase 2 study with Brilacidin. In Head and Neck Cancer patients receiving cisplatin administered in a higher concentration (80-100 mg/m2), approximately every 21 days, oral rinse Brilacidin’s results were as follows:
In the Modified Intention-to-Treat population, 71.4% of patients receiving placebo developed severe Oral Mucositis, compared to 25.0% of patients receiving Brilacidin [mITT Population] (p=0.048).
In the Per Protocol population, 72.7% of patients receiving placebo developed severe Oral Mucositis, compared to 14.3% of patients receiving Brilacidin [PP Population] (p=0.025).
The stark difference between how our drug performed against placebo will be a focus of our FDA meeting and provides us with a high-degree of confidence in the treatment potential and commercial value of our asset. As we have shared previously, our research shows there is a significant market opportunity for treating Oral Mucositis in Head and Neck Cancer patients receiving chemoradiation, as there currently is no FDA-approved drug. Of course, there are no assurances stated or implied regarding successfully developing a drug, but if we are successful, we believe that earnings from a new, easy-to-use OM drug could be many multiples of our present market cap. This keeps us driving forward in executing on our business model and building shareholder value.
In our next corporate filing (10q), we will be updating shareholders on other ongoing business and clinical development priorities.
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