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Drug Makers Overseas Are Gaining A Competitive Advantage In The Antibiotics R&D Market; Acurx Pharmaceuticals Ibezapolstat Program Is Helping Level The Field (NASDAQ: ACXP)

What people don't know won't hurt them, right? Well, not always. When it comes to drugs, the prescribed ones, not knowing what's happening can have potentially devastating consequences. And that's especially true in the antibiotics industry, where research and development are tantamount to keeping people fortified against developing drug resistance.

Moreover, as the bigger US-based pharmaceutical companies scale back their own research, patients in the US markets may not get best-in-class treatments in the years to come. In fact, for patients in the States, there has been no meaningful change to antibiotics in roughly 40 years. Acurx Pharmaceuticals (NASDAQ:ACXP) is working to change that deficient landscape.

They are also helping to change the narrative from pretending that all is well in the sector. Even the CDC is part of that rhetoric, which has years-long programs discussing the importance of developing new antibiotic treatments, especially those targeting gram-positive infections. Since 2013 they have been active in promoting its National Action Plan to Prevent Health Care-Associated Infections. They also publish a "road map to elimination." Sounds as though the United States is pushing for innovation, right? Well, yes, it appears that way. But the truth of the matter is that little to no pressure is making its way to drug developers. Many in Big Pharma have given up altogether.

That's evidenced with both Novartis (NYSE: NVS) and Sanofi (NASDAQ: SNY) all but abandoning its antibiotics development programs in 2018 and 2016, respectively. They say the cost to develop is too high. Hence, the human toll rises.

Still, not all pharmaceutical companies are throwing in the towel. Acurx Pharmaceuticals is more than up to the task of contributing substantially to the ailing antibiotics development sector. And its mission is supported by clinical data showing its ability to treat a number of gram-positive infections nothing short of remarkable. Politicians and Big Pharma should pay attention.

Effectiveness Against Gram-Positive Infections

A better idea is that they should consider joining this innovative company to help expedite its development programs. The result could be a win-win-win proposition for ACXP, investors, and patients. Keep in mind, too, ACXP's programs are designed to deliver quick results. The better news is that ACXP, fresh off its successful June IPO, isn't a pre-clinical stage company. They are already advancing a Phase2b trial to develop effective antibiotics targeting debilitating and sometimes fatal gram-positive infections. Gram-positive infections, like MRSA and C. difficle, are the ones hospital patients are most warned about as part of the "complications'" disclosure and indemnification forms they are forced to sign.

MRSA, by the way, is the most common hospital-based infection in the United States, accounting for roughly 52% of all diagnosed hospital infections. Results from getting this infection are more than serious; it can be fatal. Hence, with the majority of infections known to be MRSA, it's a telling sign for the sector that few, if any, companies other than ACXP are willing to challenge the status quo. If it's a return on investment proposition, that's a weak argument, especially with the markets being a multi-billion dollar proposition. But, the lack of competition may not be a bad thing for ACXP and its investors. Better still, as Big Pharma focuses its attention elsewhere, it does create opportunities for smaller developers. And ACXP is seizing that opportunity by sticking to what it does best. Developing innovative antibiotics.

Moreover, they are targeting an antibiotics market was valued at more than $40 billion in 2020. And by 2028, it's expected to grow to a roughly $58 billion target market. Thus, it isn't as if ACXP is focused on the wrong markets. To the contrary, the best news is that they are focused on the right market at the right time. And from an investment perspective, ACXP is widening its competitive advantage against potential other drug developers in the sector. That's excellent news as well.

Advancing Its Phase 2b Clinical Trial

More notable, ACXP may be one of the best-positioned companies in the sector to develop meaningful changes to an antibiotics market that hasn't seen significant advances for almost 40 years. The better news is that compelling interim data from its trials shows ACXP can get the job done and is rapidly advancing drug candidates to treat severe gram-positive infections. As noted, results to date are nothing short of impressive.

Foremost, know that ACXP isn't a one-drug wonder. They are advancing at least two studies. The first is a Phase 2b trial evaluating ibezapolstat against several debilitating conditions, including C. difficile. Its second program, ACX-375C, is more intently focused on treating other gram-positiveinfections. And while specific indications are noted for its trials, know that ACXP expects its platform to effectively treat numerous conditions outside of the indications mentioned. Thus, when evaluating the market potential, keep in mind that its platform is scalable, targets urgent needs, and can generate results quickly.

Of course, ACXP is only as good as its results. The excellent news here is that results have been over the top positive. So much so that regulators approved ACXP to terminate its Phase2a trial early and move directly to a Phase2b trial. While results there impressed, ACXP expects to show even more compelling results later this year.

Here's what attracted attention.

Regulators Embraced Phase2a Results

Foremost, results from its Phase2a arm of its trial utilizing ibezapolstat as a potential front-line treatment for C. difficile (CDI), a debilitating germ that causes severe diarrhea and colitis, were compelling. So good, in fact, that investors sent shares soaring by more than 45% intraday upon release of the data. And that gain was well-deserved.

Rarely does a clinical trial show 100% effectiveness. ACXP's did. Data published showed that using ibezapolstat in patients with CDI delivered a 100% cure rate and 100% sustained clinical cure after 30 days of treatment. Also compelling is that interim data further suggest that its candidate can be a potential front-line treatment and replace current standards of care that leave a high burden of C. difficile in the gut. Analysis also showed that ibezapolstat shows enormous potential to replace current treatments that often lead to CDI recurrence in up to 40% of patients once their therapy stops.

And as noted, its Phase2a trial results were impressive enough for regulators to approve early termination of segment 2a and move directly to a Phase 2b trial. Interim results from that trial may not take long to get, noting the relatively short-term (10 days) treatment cycle compared to traditional drug development studies. Hence, catalysts could be on deck.

Keep this in mind, too. ACXP is so confident in its drug candidate that its Phase 2b arm of its trial lines up ibezapolstat against Vancomycin, the current standard of care. The study intends to treat 64 patients over 10 days, with 32 patients dosed ibezapolstat and the remaining 32 patients dosed with Vancomycin. Expect investors, Big Pharma, and medical professionals to pay attention. Know this too, if ibezapolstat bests Vancomycin in the final analysis, AXCP could benefit from more than potential QIDP and Fast-Track designations. They would likely be courting several Big Pharma players wanting a piece of the action. That's to be expected. Big Pharma no longer develops; they acquire.

Factor this in as well. Its Phase2a results treating patients with mild to moderate CDI with orally administered ibezapolstat showed best-in-class results, reaching both primary and secondary of initial and sustained cure. Those results help temper risk as well.

And while ibezapolstat is positioning to replace decades-old treatments, its other clinical asset is also generating compelling data. That drug candidate also targets a relatively untapped market.

Targeting Gram-positive Infections With DNA Poll IIIC

ACXP's second ongoing study collaborates with WuXi AppTec to advance its pre-clinical development pipeline of antibiotic candidates targeting several critical and unmet treatment indications. Like its Phase2b trial, this study also targets severe conditions, evaluating its DNA Pol IIIC inhibitor, ACX-375C, to treat severe infections, including Staphylococcus, Streptococcus, and Enterococcal infections. Acurx, by the way, is confident in results to date, leading them to further believe the drug shows promise to treat other G+ resistant bacterial infections, including VRE and MRSA, which, as noted, are highly debilitating and sometimes fatal infections.

And beyond those applications, ACXP expects the drug can effectively treat more general clinical indications, including urinary tract, hospital-acquired catheter/bloodstream, bone/joint, pneumonia, and ear and sinus infections. Thus, if approved, ACX-375C can target multiple shots on revenue-generating goals. For investors and patients, that will be welcomed news.

Best of all, both of its assets have more than best-in-class potential. Results can be published quickly, sometimes in weeks compared to years for traditional drug candidates.

Putting Value In-Play

Indeed, ACXP deserves attention. And by only coming to the public markets in June, it's understandable for its stock to still be trading under the radar. Still, that's good news for investors wanting a relative ground floor opportunity in a company positioned to deliver the first meaningful chance in antibiotics in decades.

Moreover, the share price appears to neglect two potential near-term trial catalysts, its low O/S count of about 9.9 million shares, and potential updates regarding Fast Track or QIDP designations. Any of those events could send shares back toward their all-time highs. Still, some investors are greedy and want more to justify the investment. The great news there, ACXP can again deliver.

In the coming weeks, ACXP will likely commence its Pre-IND Pharm/Tox studies for ACX-375C, seek Fast-Track designation for ACX-375C, provide an interim update from its ibezapolstat trial, and provide data supporting its potential to treat COVID-related infections. Thus, there's more than a trifecta of opportunity not yet built into the share price, making the next few weeks a potentially exciting period for ACXP and its investors.

Indeed, ACXP may not stay under-the-radar much longer.


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