As president, CEO and a co-founder of Dipexium Pharmaceuticals (NASDAQ:DPRX), David Luci, and executive chairman and co-founder, Robert DeLuccia, have spearheaded development of Locilex, which could be the first FDA-approved antibiotic specifically to treat mild infections of diabetic foot ulcers (DFI). The two men were instrumental in acquiring the worldwide writes to Locilex five years ago and leading its reformulation and clinical progress. They are experienced pharmaceutical executives with a proven track record of success in drug development and partnering with, and selling to, Big Pharma. In this interview with BioTuesdays.com, Mr. Luci discusses the clinical status of Locilex in the U.S., plans for regulatory approval in Europe and commercialization.
How would you summarize Locilex’s efficacy to date?
Locilex is a topical antibiotic cream that has demonstrated efficacy at treating the pathogens that cause skin infections in superficial wounds in both clinical and microbiology studies. In two prior Phase 3 trials in DFI versus a systemic antibiotic control, Locilex demonstrated clinical and microbiological statistical non-inferiority in a combined analysis, although it missed statistical significance in one-of-two Phase 3 studies.
Locilex is currently being studied in two pivotal Phase 3 placebo-controlled trials being conducted in the U.S. These trials are double-blinded and, accordingly, we have no efficacy data until the trials are unblended. We anticipate the trials will complete enrollment with top-line data available in the second half of 2016.
How does Locilex differentiate itself from other antibiotics?
Locilex is different than other antibiotics because it is extremely broad spectrum; killing gram-positive and gram-negative pathogens, resistant pathogens and killing aerobic and anaerobic pathogens. It is also different in that Locilex is actually bactericidal so it is killing the bacterial cells; not just stopping them from replicating. Finally, Locilex is a topical cream with no evidence of systemic absorption; this is a key feature because of the proliferation of resistant bacteria or superbugs and use of Locilex will extend out the use of conventional systemic antibiotics for more serious infections.
What are the drawbacks of oral antibiotics?
Overuse of oral antibiotics leads to the proliferation of resistance to the entire class; the proliferation of antibiotic resistant superbugs. This means that the more often an antibiotic is used the less effective it is to treat any infection. With so few antibiotics being developed and approved, the proliferation of resistant bacteria has become a public health crisis. Oral antibiotics also have toxic side-effects in many cases and can’t be relied on for diabetic foot infection in patients with peripheral vascular disease because the systemically administered antibiotic will have no way to arrive at the local site of the infection absent blood vessels.
What is the unmet medical need Locilex is targeting?
Mild infections of diabetic foot ulcers. There is no approved product, antibiotic or otherwise, to treat this segment of the diabetic foot infection population and none have any clinical data in support of off-label use.
What’s the status of Locilex’s Phase 3 trials?
We are over 80% completed with enrollment in our pivotal Phase 3 trials of Locilex versus placebo cream in a double-blind superiority study being performed at 70 clinical trial centers across two studies all conducted in the US. The primary endpoint in these trials, which are identical and being conducted in parallel, is resolution of infection. We have a special protocol assessment agreement with FDA on the trial design of these pivotal Phase 3 studies.
Are you seeing evidence of wound closure?
We are seeing evidence of wound closure in these studies although we caution that the data is blinded and so, we are unsure until the data is unblinded, if this is attributable entirely or primarily to the Locilex arm of the two studies.
What’s the market opportunity you’re addressing?
There are approximately 650,000 patients treated each year for mild DFI in the U.S. alone. The incidence in Europe is less but approaches the U.S. incidence. We believe that we can achieve a sales penetration of 55% in mild DFI and 30% in moderate DFI, if used in combination with a systemic antibiotic. Our financial modeling is based on a $600 price for treatment in the U.S. and $280 in Europe, both as fully reimbursed prices.
What’s the regulatory pathway in the U.S. and Europe?
Assuming the Phase 3 studies are successful, we hope to file for approval in the U.S. in the first half of 2017 and in Europe in the second half 2017. In the U.S., we would anticipate a response from FDA within six months, given we would anticipate filing a new drug application amendment to which a six-month regulatory clock applies.
Can you outline your commercialization plan?
Our plan would be to continue to run Dipexium as a virtual company as we have throughout the clinical development stage of our corporate development. Accordingly, we would appoint two-to-three members of our commercial team directly in the U.S. and, separately in Europe, while adding a fully dedicated team of sales representatives through a contract sales organization for the first three years from the marketing launch. We would anticipate that the sales team in the U.S. would gradually increase to up to about 125 sales representatives and up to 50 sales representatives in Europe, both by year six, which we estimate will be the year of peak sales, according to our financial estimates.
What’s your growth strategy re: label expansion and SSTIs?
We believe we can expand Locilex’s label to treat infected bed sores, surgical wounds and burns, as well as venous stasis ulcers. If your antibiotic is a topical and you’re targeting superficial wounds and you can kill the bug in microbiology studies, you know what the pathogens are. So, if it works in microbiology studies, it should work on the skin.