Acurx Pharmaceuticals (NASDAQ: ACXP) isn't trying to be difficult in the antibiotics sector. They are, however, willing to be disruptive. Give them credit. After 40 years of the same drugs treating more resistant infections, ACXP is doing the right things at the right time.
And whether it's through its Health Holland project evaluating DNA Pol IIIC Inhibitors or through its fast-moving Phase 2b clinical trial here in the United States, ACXP is on the path to change an antibiotics landscape that has been at a virtual standstill still the 1980s. Investors should embrace the situation.
Better yet, being invested in disruptive companies can be rewarding. In fact, when investors take a stake in companies that can deliver meaningful changes to billion-dollar market opportunities, the results are often exponentially positive. Being early to that opportunity can also provide the highest rewards. Such a scenario is already in play at Acurx Pharmaceuticals.
Aggressive Plan Targeting Gram-Positive Infections
And the pace is fast. ACXP is aggressively interested in bringing attention and treatment to Gram-positive infections, many of which are more than debilitating; they can be fatal. Actually, they are following the guidance of the CDC, BARDA, CARB-X, and of course, the NIH that know treatment for gram-positive infection is a critical and often unmet medical need. And in the most powerful country in the world, when it comes to drug research and development, leaving these nasty infections to wreak havoc on millions of patients each year makes little sense.
Well, maybe it does when dollars are involved. And the Big Pharma companies like Novartis (NYSE: NVS) and Sanofi (NASDAQ: SNY), which acknowledge the billion-dollar market potential of these treatments, have all but abandoned their own research as ROI wasn't at a level acceptable to their business models.
Still, it's not all about ROI. For at least the past decade, Big Pharma has been acquiring drugs, not developing them. Hence, just because they aren't in the clinic doesn't mean they don't have their eye on opportunities. And with ACXP delivering stellar Phase2a trial results to treat EPI in patients with C. difficile, they may be on the screens of several. The results were so compelling, in fact, that regulators allowed for early termination of its Phase2a arm and allowed a move directly into its Phase 2b study.
That allowance brings ACXP a giant step closer to getting an effective treatment for EPI in patients with C. difficile to market. Better still, while not a part of its endpoint designs, ACXP believes it sees compelling evidence that its treatment platform could extend its efficacy toward multiple other gram-positive infections.
That's especially important at a time when Chinese drug developers are hoarding some of the world's most needed antibiotics as a bargaining chip in trade deals. Thus, the ACXP clinical-stage programs are more than timely; they are critical to meeting the needs of the US population.
More compelling to the investment proposition is that few, if any, other clinical-stage companies are focused on doing what ACXP is doing. Many of its peers are still researching gram-negative infections, entirely ignoring the pace at which the gram-positive infection rates are growing.
Know that gram-positive infections can be fatal for hospital patients, with more than 50% of them attributed to MRSA alone. Thus, while treating C. difficile is in the immediate treatment crosshairs, the broader ACXP platform may have an inherent ability to counter numerous multi-drug resistant (MDR) and sensitive gram-positive bacterial pathogens. That's excellent news going forward.
For the here and now, ACXP, its investors, and treatment professionals may be embracing the fact that much-needed help to treat ACXP's first treatment indication is near. As noted, ACXP advancing through its Phase 2b trial specifically targeting C.difficile, and its Phase2a results demonstrated potentiallybest-in-class treatment. With licensing, partnerships, or grant funding, all of which may be in play following its 100% rate in meeting primary and secondary trial endpoints, its Phase2b portion of the trial could be accelerated.
Notably, the trials are relatively short in duration, with most patients treated and evaluated over a 28-day cycle.
Disrupting The Status Quo
And it's that speed of treatment and the accompanying results that keeps ACXP an attractive near and long-term investment opportunity. No medical professional questions the need for a new line of antibiotics targeting gram-positive infections. They would indeed quickly note a substantially greater incidence of drug-resistant gram-positive bacterial infections than gram-negative. Moreover, the impact of these infections goes beyond health; it affects populations socially and economically as well.
But with C.difficile already in ACXP's crosshairs and showing potential front-line treatment capability, the first of several treatment answers may be close. And keeping in mind that ACXP is building its platform to be scalable, the potential for follow on therapies could come quicker than expected.
Better still, the platform is designed to keep pace with virus and infection mutations, which can render freshly approved treatment relatively obsolete in less than a decade. According to ACXP's design, it's an inherent feature of its innovative drug development platform.
The Here and Now Targets C. difficile
Still, that's down the road. The here and now has ACXP working to mimic the phenomenal results from the Phase 2a segment of its C.difficile trial. The Phase 2b arm, which earned an early move to Phase2b from regulators, 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.
It's not a new problem, either. CDI has been challenging drug developers for decades, with no treatment able to effectively battle the symptoms. The excellent news today, however, is that ACXP's interim data to date shows that ibezapolstat has the potential to become a best-in-class treatment after posting 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.
Better still, results are leading to a battle against standard of care treatment Vancomycin. And ACXP expects to win, with data showing that Vancomycin can leave a 40% chance of recurrence in patients once their treatment ends. Ibezapolstat doesn't. Hence, in relatively short order, results from the ACXP Phase 2b arm of the trial can potentially dethrone the current standard of care.
Moreover, if the final analysis shows that ibezapolstat performs better, expect ACXP shares to respond favorably. In fact, expectations are for ACXP to become immensely popular in the sector, especially after beating a drug market leader that has held the space for decades. Again, professionals aren't doubting the need for a better drug. And if they get a better option, expect them to embrace the better standard of care alternative. In turn, ACXP could earn the lion's share of a multi-billion dollar treatment market.
The investment proposition in ACXP doesn't stop there. They have more clinical firepower in their arsenal.
ACX-375C Taking On Additional Gram-Positive Infection
Acurx has another asset deserving attention. Like ibezapolstat, it too can have front-line and best-in-class effectiveness. And while it's in pre-clinical stages, with results not likely to be published for at least two years, getting ahead of the trade may not be a bad idea. Traders regularly trade on Phase 3 trials that are many years away from topline results. Getting in at pre-clinical stages, when results are promising, helps capture all the value at hand.
It, too, is a potentially broad platform with early indications suggesting it has 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 and is evaluating the DNA Pol IIIC inhibitor to treat multiple infections, including Staphylococcus, Streptococcus, and Enterococcal infections.
Pre-clinical data to date support the treatment candidate, 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, including 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. And while a $500,000 grant from Health Holland may help expedite the early stages of the study, investors should value this program as a pipeline asset that needs time to develop. With that said, positive results at any level draw attention. Thus, any update can affect ACXP's share price.
Milestones In Play For Second Half Of 2021
For investors that buy into disruptive companies, ACXP checks all of the boxes. They have compelling Phase 2 data, are targeting antibiotics markets that are in dire need of better drugs, and are near to taking its drug candidate against the standard of care to treat C. difficile. Hence, a near-term catalyst could be near, with the trials lasting only about 30 days.
Even better, ACXP is developing a platform, not just a single drug. That puts multiple revenue-generating shots on treatment goals in play during the next 6-24 months. And with billion-dollar drug markets as the prize and with very little expected competition, it's likely to see ACXP shares bid higher as the trials progress.
Also, to those paying attention, ACXP provided clues to hearing about potential near-term value drivers. In queue could be interim data from its Phase 2b trial, filing for Fast Track and QIDP designations, and possibly earned grant funding. Announcements on any of those could come sooner rather than later.
Still, if the results from its ongoing Phase 2b trial are as good as expected, the first leg higher toward a more appropriate valuation for a late-stage drug development company may be near, possibly in as little to 3-6 months. Thus, while to some, that's a long-term proposition, to more seasoned investors, taking an early position in a potentially game-changing, industry-disupting company is well worth the wait. The latter may be the prudent choice.
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