IPIX Laser-Focused on IBD and OM as Fastest Path to Revenue
2 Clinical Trials in IBD Expected in 2020
Company Exploring Partners in OM for Phase 3 Trial
My Fellow IPIX Shareholders,
Seeing the acquisition of The Medicines Company by Novartis for $9.7 billion this week reminds me of the path they took to exit the infectious disease business through the sale of the unit to Melinta Therapeutics in November 2017 and use the money towards another direction. As we learned, infectious disease is a notoriously onerous and expensive indication for developing new drugs. The Medicines Company exited that space to focus on the more lucrative cardiovascular space, namely its experimental cholesterol-lowering drug Inclisiran that was the prize in the Novartis acquisition.
Melinta’s stock has suffered ever since the acquisition, which we think speaks to the infectious disease environment at this moment, particularly ABSSSI (Acute Bacterial Skin and Skin Structure Infection). This underscores our decision to shelf Brilacidin in the infectious disease space for the time being as we focus on what we believe are much better risk/reward opportunities in Inflammatory Bowel Disease (IBD) and Oral Mucositis (OM).
Make no mistake about it, 100% of our efforts are being devoted to the shortest path to revenue with the lowest risk profile. That is IBD and OM.
Based upon our discussions with potential partners and interested parties, it is clear that IBD is the area of greatest demand due to market size and need for new alternatives. To that point, IBD presents an enormous opportunity and we feel our team has made significant headway heading into 2020.
Earlier this year, we set a goal to advance Brilacidin into two clinical trials for IBD by mid-2020 with the understanding that we needed to partner to have the resources to meet our goal. Our new European partner provided us with some upfront cash, with payments owed for meeting developmental milestones along with future royalties on sales, which we believe could net us millions of dollars in revenue annually should the drug ultimately be commercialized by our partner for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Importantly, they are shouldering all developmental costs for those indications. We also get the added benefit of more clinical data on Brilacidin from their studies.
We are working diligently to initiate our own company-sponsored studies for Ulcerative Colitis (UC), which, as we have said before, is a much larger patient population and market size than UP/UPS. The Brilacidin for the planned UC study is now in the hands of our manufacturing partner to be formulated for targeted delivery to the colon and documents have been submitted to health authorities for the study. We hope that one day we will look back at the decision to aggressively pursue IBD as the watershed moment for the franchise and our company.
Oral Mucositis
We are engaged in licensing discussions with potential business partners for Brilacidin for the prevention of severe oral mucositis. In addition, we retained a prominent advisory company to help us with plans for this asset. We believe there is a tremendous unaddressed market that has the ability to generate billions of dollars in lifetime revenue for a company that can successfully develop a safe and highly efficacious, FDA-approved drug for OM. If we don’t receive an appropriate licensing offer, we will seek an internal pathway to begin advanced late stage clinical trials.
Leo Ehrlich, CEO
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning the future execution of a definitive agreement with a global pharmaceutical company and the anticipated terms thereof, our future drug development plans, other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock under securities purchase agreements; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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