Governments around the world are really good about spending money. The problem, however, is that the dollars spent, more often than not, go to projects that either don't need the cash or to programs that don't target a compelling need. That's especially true in the drug research and development business. In fact, that sector presents countless examples of financial waste, most evident from grants floating money to ambitious projects that either have no compelling medical need or are potentially decades away from approval. However, one company, in particular, wants to disrupt the status quo and intends to bring change to an antibiotics market that hasn't had a significant therapeutic upgrade in 40 years. That company is Acurx Pharmaceuticals (NASDAQ: ACXP).
And they aren't following the pack. Instead, ACXP is leading the charge to develop effective antibiotics targeting debilitating and sometimes fatal gram-positive infections. MRSA (pronounced Mersa) is one of its targeted indications. And their doing so could be excellent news for hospital patients, with MRSA the most common hospital-based infection in the United States, accounting for roughly 52% of all diagnosed hospital infections. Its devastating effects are also well known.
Interestingly enough, the CDC is well aware of the problems gram-positive infections create for patients. Since 2013 they have been active in promoting its National Action Plan to Prevent Health Care-Associated Infections. They even publish a "road map to elimination." Sounds great, right? Well, yes, the intent is excellent. However, its execution to help get a drug to market is severely lacking.
Still, with help from innovative companies, the better news going forward is that their mission can help produce change. That's especially true if the CDC funds fewer awareness programs and instead puts more dollars toward mid to late-stage clinical programs that show promise in treating these critical types of infection. Acurx Pharmaceuticals is one company they should consider. Its data to date is nothing short of impeccable.
Keep in mind, this isn't an infomercial. This coverage intends to bring attention to a critical unmet medical need where only a few companies are actively involved in developing meaningful and effective solutions to decades-old problems. Yes, from an investor's perspective, ACXP offers a compelling investment opportunity. But from a humanitarian side, its work can be a lifesaver to thousands of patients per year. The even better news is that ACXP is already advancing Phase 2b trials in a mission to bring relief to patients sooner rather than later.
It also means that catalysts could be near.
Changing 40 Years Of The Same 'Ole
Better still, in addition to posting potential near-term catalysts, ACXP may be one of the best-positioned companies in the sector to develop meaningful changes to an antibiotics market whose development side has been stagnant for 40 years. They also pick up where Big Pharma left off, with both Novartis (NYSE: NVS) and Sanofi (NASDAQ: SNY) all but abandoning its antibiotics development programs in 2018 and 2016, respectively.
Interestingly enough, it's not that researchers can't develop better treatments; it's just they have been focusing elsewhere. And while targeting MRSA and other debilitating infections may be getting overlooked by those wanting to treat gram-negative infections, for ACXP, it can be the low-hanging fruit of opportunity that can create substantial value for the company and save thousands of lives in the process. Moreover, with earned federal, local, or private grants added to the equation, ACXP may be the best-positioned biotech to quickly deliver a meaningful gram-positive antibiotic to market. And the way things look today, they deserve the attention- and funding.
That's especially true with ACXP showing it can get the job done. And while it goes without saying that these advances in antibacterial care should have been developed sooner, they weren't. However, ACXP is hot on the heels of taking these severe gram-positive infections down. And that's more than research news of the day; it should be known throughout the antibiotics sector. Here's why:
Foremost, know that while Acurx may be new to the public markets, they aren't new to the clinic. They are advancing two studies. One, 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-positive infection. Both programs, by the way, have the potential to treat numerous conditions outside of the indications mentioned. Thus, its platform is scalable, targets an urgent need, and can generate results quickly.
Here's a bit of better news. ACXP's Phase2a trial results were so impressive that regulators approved an early termination of that study and approved a direct move to a Phase2b trial. While results there impressed, ACXP expects to show even more compelling results later this year.
The more excellent news on that front is that, unlike research that may take years to reach an endpoint, ACXP typically can treat a patient for ten days in a cycle and see results quickly. Its trial design saves money, can earn regulatory review quicker, and allows ACXP to position itself for multiple strategic opportunities and options as data gets published.
In simplest terms, its program design offers a potential trifecta of benefit, which is a welcome position to be in for a company nearing its first of many potential catalysts.
C. difficile And Gram-Positive Infections Are Billion-Dollar Franchises
Its most near-term catalyst could be born from its Phase2b trial utilizing ibezapolstat as a potential front-line treatment for C. difficile (CDI), a debilitating germ that causes severe diarrhea and colitis. Interim data released last month was impressive, prompting shares to surge 45% higher intraday following their release. Frankly, the run should have been better than that, noting that the results published were about as good as they could get.
Rarely is there a study showing 100% effectiveness. ACXP's did. Data showed that using ibezapolstat in patients with CDI delivered a 100% cure rate and 100% sustained clinical cure after 30 days of treatment. Needless to say, that's an excellent precursor for things to come.
Still, as good as those results are, ACXP expects to be able to take the drug a few steps further, believing its data shows its candidate can target other antibiotic development opportunities created by COVID-19. And with the Delta variant causing a surge in new infections globally, ACXP may be better-positioned than many to earn more than cursory look from global decision-makers scrambling for an effective treatment against the virus. Big Pharma is probably watching as well.
Still, while its applications to treat COVID are promising, it shouldn't be a distraction from showing its best-in-class potential in treating CDI. Already, interim data 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. Better yet, ibezapolstat is showing its potential to replace current treatments that often lead to CDI recurrence in up to 40% of patients once their therapy stops. Notably, ACXP's candidate has remarkably different results.
As noted, its Phase2a trial results were so impressive that regulators allowed for early termination of segment 2a and approved direct advancement to a Phase 2b trial. But a more significant takeaway is that with the treatment cycle being relatively short-term (10 days) compared to traditional drug development studies, data is typically imminent. Hence, for the foreseeable future, news may keep ACXP in play.
Speaking of news, investors could soon get some from ACXP's Phase 2b arm of its trial intending to treat 64 patients over 10 days, with 32 patients dosed ibezapolstat and the remaining 32 patients dosed with Vancomycin, the current standard of care. The watch party here is focused on ACXP putting ibezapolstat head-to-head with the market leader, Vancomycin. And know this, if ibezapolstat can best Vancomycin in the final analysis, expect more than QIDP and Fast-Track designations. Multiple opportunities, including licensing and partnerships, could be put into play.
Keep in mind, too, its Phase2a results treating patients with mild to moderate CDI with orally administered ibezapolstat were beyond good. They showed best-in-class results. The study reached both primary endpoints, showing patients dosed with 450mg twice daily for 10 days meeting primary and secondary efficacy endpoints of initial and sustained cure. Better still, treatment was well-tolerated, and patients reported no severe adverse reactions.
Here's the best news. While ACXP's ibezapolstat study shows potentially best-in-class results, they have another asset in the clinic generating compelling data as well.
That drug candidate also targets a relatively untapped market.
Targeting Gram-positive Infections
More importantly, it's targeting additional opportunities for treating gram-positive infections. This study collaborates with WuXi AppTec, with the two advancing its preclinical development pipeline of antibiotic candidates targeting several critical and unmet treatment indications. And the optimism that ACX-375 can deliver substantial improvement of treatment shows, with the two already in the late-stage processes of completing the manufacturing and formulation of ACX-375C to treat Gram-positive infections.
The study also targets severe conditions, evaluating its DNA PolIIIC inhibitor, ACX-375C, to treat severe infections, including Staphylococcus, Streptococcus, and Enterococcal infections. Already, Acurx believes that early data shows promise for the drug to treat other G+ resistant bacterial infections, including VRE and MRSA, which, as noted, are highly debilitating and sometimes fatal infections.
Moreover, ACXP expects its drug to do much more. In fact, ACXP thinks the drug may 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 capitalize on having multiple shots on revenue-generating goals and potentially become a revenue-generating juggernaut for the company.
And while this program is further behind in terms of stage, that doesn't mean that compelling data won't attract interest. And with Big Pharma now acquiring instead of creating, expect them to have their eyes peeled for potentially industry-changing treatments.
Both of ACXP's drug candidates fit that mold.
Catalysts On Deck
Thus, its successful IPO in June, which was met with enthusiasm, may be a precursor of bigger things to come. Indeed, with two potential catalysts on deck and only about 9.9 million shares outstanding, any positive update could significantly impact the share price. Better still, earning fast track or QIDP designations, which they are expected to apply for, could send the shares soaring sooner than many expect.
But, for investors needing more than those two designations to commit to a position, consider this as well. 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. That update could be the most powerful of all
So, for investors that like action, pay attention. The next few weeks may present exciting times for ACXP, its shareholders, and potential patients. And with a win-win-win proposition in play, ACXP is indeed ripe for investment consideration.
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