Gram-positive infection is in critical need of attention. The CDC knows it, BARDA knows it, CARB-X knows it, and of course, the NIH knows it. That's a lot of knowing, right? Then it begs the question as to why so much attention and financial support from these agencies is going toward gram-negative bacteria studies. And at the very least, why aren't they splitting the funding pie. After all, more than half of all hospital-based infections are from gram-positive bacteria. With that being the case, companies need to jump in and help change the narrative.

The excellent news is that a few companies are doing just that. Acurx Pharmaceuticals (NASDAQ: ACXP) is one of them, and it could help put them into a leadership position to develop effective treatments targeting a multitude of gram-positive infections. Right now, they are targeting C. difficile. However, by making its platform scalable, future treatment targets could include MRSA, VRE, and Streptococcus, to name a few. For those that had any of those mentioned, the journey back to health was probably not easy. For others, the outcome could have been fatal. Therein lay the urgent situation at hand.

The best news is that much-needed help may be near, with ACXP advancing through its Phase 2b trial specifically targeting C. difficle. And with its studies relatively short in duration, patients may have new best-in-class options sooner rather than later. Better still, more than showing its ability to develop meaningful treatments, ACXP is also helping to move the discussion needle to bring attention toward innovative antibiotic development programs that will meet a critical and currently unmet need. 

Compelling Need For New Antibiotics

Indeed, the need for a new line of antibiotics targeting gram-positive infections can't be overstated. Worldwide, there is a substantially greater incidence of drug-resistant gram-positive bacterial infections compared to gram-negative. Its impact goes beyond health; it affects populations socially and economically as well.

And until policymakers get involved in helping to expedite a national push to create better treatments, it will be up to companies like ACXP to develop assets targeting the three primary categories of drug-resistant gram-positive infection and also take the place of Big Pharma notables like Novartis (NYSE: NVS) and Sanofi (NASDAQ: SNY) who have stopped their antibiotics development programs altogether. Hence, ACXP is doing the right thing at the right time. 

Better still, they are hoping to deliver milestones sooner rather than later. And that would be welcome news to the CDC, and others, who note the need to develop effective treatments targeting, among others, CDI, Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococci (VRE), and Penicillin-resistant Streptococcus.

C. difficle is already in ACXP's crosshairs. And early data suggests that its scalable platform may be able to later expand its targeted indications. That's important to note. Bacterial infections, like all life, want to survive. Thus, as they continually evolve to counter the efficacy of current antibiotics, maintaining an ability to keep pace with variants is critical in the development process. That's an inherent feature of the ACXP platform.

Hence, ACXP is hoping to give the human immune system one less thing to worry about. And in doing so is positioned to deliver a best-in-class front-line solution to fend off these debilitating infections. Thus far, ACXP is showing remarkable results in doing so.

ibezapolstat Targeting CDI

In fact, its Phase 2b clinical trial is hoping to leverage the phenomenal results from the Phase 2a arm of the study. The Phase 2b arm is evaluating ibezapolstat's effectiveness in treating C.difficile(CDI), a debilitating, weakening infection with symptoms including severe diarrhea and life-threatening inflammation of the colon. And while an effective way to treat CDI has been challenging drug developers for decades, the excellent news is that ACXP's interim data to date shows that ibezapolstat has the potential to become a front-line treatment after delivering a 100% cure rate and 100% sustained clinical cure after 30 days of treatment. It's a more than impressive data set that could lead to industry-changing antibiotic developments.

At the same time, it can fortify ACXP's position in the antibiotic development space by showing its drug candidate's ability to tackle current indications and be potentially effective in treating other gram-positive bacteria that continuously mutate. Of course, mutations, like the Delta variant of COVID, make it increasingly difficult for pharmaceutical companies to counter. And without a scalable platform, an effective treatment today could be potentially mitigated by the following year.

Adaptive capability is a big part of what's attracting investors to ACXP. That's especially important to Big Pharma, who now generally acquire drugs instead of taking them through R&D processes themselves. That new reality makes ACXP even more compelling on the valuation side of its equation.

Still, its results deliver the bulk of the inherent value. As noted, they were excellent. Moreover, it is one of the few, if only, CDI treatment candidates that can best the current standard of care, which is known to leave a 40% chance of recurrence in patients once their treatment ends. Better still, ACXP's Phase 2a data was so compelling that regulators allowed the company to terminate that study early and advance directly to a Phase2b trial. That's where they are now.

The Phase 2b arm of the trial can potentially dethrone the current standard of care, Vancomycin. In fact, ACXP is putting ibezapolstat in direct competition with that drug. Hence, if the final analysis shows that ibezapolstat performs better, expect ACXP shares to respond favorably. It would also be likely that the company would become immensely popular in the sector, especially after showing potential to bring a new best-in-class front-line treatment to market.

And with the CDC making it clear that the treatment of CDI presents an urgent and critical need, their influence could feasibly help ACXP accelerate from a development-stage company to commercial-stage biotech.

The better news is that ACXP has even more clinical firepower in its arsenal.

ACX-375C Targeting Gram-Positive Infection

Acurx has an additional asset also deserving of attention. It too can have front-line and best-in-class effectiveness. And while its in pre-clinical stages, it's a potentially broad platform showing an inherent ability to counter numerous multi-drug resistant (MDR) and sensitive gram-positive bacterial pathogens. Called ACX-375C, the study intends to create a systemic gram-positive selective spectrum (GPSS) bactericidal antibiotic.

The pre-clinical program is also a collaborative effort with WuXi App Tec. It has the two working on inhibiting DNA Pol IIIC to treat multiple infections, including Staphylococcus, Streptococcus, and Enterococcal infections.

Data to date is also impressive, already suggesting that ACX-375C can be effective against multiple gram-positive resistant bacterial infections. Primary targets of the drug could be MRSA and VRE. However, similar to ibezapolstat, its platform scalability could open its potential to treat numerous other infections.

Those could include more common indications such as ear and sinus infections, urinary tract infections, bone/joint infections, and pneumonia. Keep in mind, though,this program is advancing through its pre-clinical investigatory stages. Hence, while bringing potentially lucrative treatment and revenue-generating opportunities to ACXP, give this one at least a year or two to develop.

Hitting Milestones And Posting Catalysts In 2H 2021

Indeed, Acurx is on the verge of helping to change the antibiotics landscape. And the better news is that its programs don't only target a single indication. Instead, both of its programs are designed to evaluate effectiveness in treating multiple types of infections. Better still, these markets all bring billion-dollar market opportunities into play.

The next weeks could also help set the stage for growth into the final quarter of this year. Interim data from its Phase 2b trial, filing for Fast Track and QIDP designations could be part of a list of near-term catalysts, too.

Moreover, if Phase 2b results post as good as expected, investors will probably react as they should and send shares substantially higher, knowing that the drugs can be more than game-changing to the markets; they can be transformative to ACXP as well.

Thus, while ACXP is under the radar for now, it's likely they can be quite well known within the next two business quarters. Catching value at these undervalued levels may be a compelling proposition.

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