Acurx Pharmaceuticals (NASDAQ: ACXP) is on pace to do something that few drug development companies have paid attention to in decades- create a better, more effective line of high-performing antibiotics. Why the attention now? Because since the 1980s, the current standard of care antibiotic has been unable to keep pace with changing immune systems that have learned to fight off attacking compounds. That's not to say they don't work. However, their efficacy is weakening, and it's indeed time for a better standard of treatment.
And while it goes without saying that these changes should have been developed sooner, they weren't. But, that lapse allows ACXP to take the lead in the initiative.
In fact, ACXP is already deep into the game with its Phase 2b trial evaluating ibezapolstat against several debilitating conditions, including C. difficile, and its ACX-375C study targeting gram-positive infection. The potentially greater news for ACXP investors is that the company may be the farthest along than anybody when it comes to advancing new antibiotic trials. And being well-financed after its successful IPO and having only about 9.9 million shares outstanding doesn't hurt, either.
Moreover, while the shares have been consolidating after a strong IPO run in June, regulators have been more progressive, granting ACXP approval to end its Phase2a trial early based on compelling data. Regulators approved a direct move to a Phase2b trial. And that allowance is timely, especially with ACXP developing its antibiotic candidates to meet critical and underserved medical needs.
Targeting C. difficile And Gram-Positive Infections
Its Phase2b trial utilizing ibezapolstat, for instance, is being developed as a potential front-line treatment for C. difficile (CDI), a debilitating germ that causes severe diarrhea and colitis. That program could be why investors sent shares 45% higher intraday following the interim data released earlier this month. Or, perhaps the price shot higher because ACXP's results were about as good as they could get from its Phase2a arm. Both reasons are good ones. And here are the details.
ACXP showed that using ibezapolstat in patients with CDI, ACXP delivered a 100% cure rate and 100% sustained clinical cure after 30 days of treatment. Even better, beyond its targeted indication in the trial, ACXP believes the data also exposes an opportunity to leverage the drug applications to target other antibiotic development opportunities created by COVID-19. And with a surge in new infections from potentially hard-to-treat variants, ACXP may be more than timely; they can be lifesavers. And as policymakers worldwide scramble to find alternative ways to treat these mutating viruses, companies like ACXP are certainly in play. Remember, Big Pharma rarely produces a new drug- they acquire them, making ACXP attractive to many potential suitors looking to partner or license its programs.
Still, ACXP's treatment lasting power will go on long after Covid is put under control, with data from its Phase 2a trial suggesting that Acurx is well on its way to replace the current standard of care treating CDI. Its data shows its candidate can be far better to replace current treatments that leave a high burden of C. difficile in the gut that often leads to recurrence of CDI in up to 40% of patients once their therapy stops. ACXP's candidate is compellingly different.
And, 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. Perhaps the biggest takeaway is that with the treatment cycle being relatively short-term (10 days) compared to traditional drug development studies, the time may be ripening for the first of several potential catalysts.
The Phase 2b arm of the trial intends 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 big news here is that ACXP is putting ibezapolstat head-to-head with the market leader. Thus, if ibezapolstat can best Vancomycin in the final analysis, expert more than QIDP and Fast-Track designations. Shares prices would likely rise appreciably as well.
Best of all, by showing best-in-class potential to treat targeted billion-dollar indications, ACXP will be exceptionally well-positioned to capitalize on strategic opportunities, including potential partnerships and licensing opportunity interests. Remember, Big Pharma likes to acquire, not develop. And with ACXP emerging as the favorite to deliver effective first-line treatment to patients with C. difficile, which the CDC and CDI classify as an urgent threat requiring new antibiotic development, attention from that group could come sooner rather than later. Notably, ACXP's data suggest that its drug could be the first to replace decades-old antibiotics with recurrent CDI infection rates of between 20% - 40%.
Keep in mind, too, its Phase2a results treating patients with mild to moderate CDI with orally administered ibezapolstat showed best-in-class results. Its data met both primary endpoints, showing patients dosed with 450mg twice daily for 10 days meeting primary and secondary efficacy endpoints of initial cure and sustained cure. Also important, the treatment was well-tolerated, with no severe adverse reactions reported.
Keep in mind, too, that while ACXP may be on pace to develop a much-needed drug to treat CDI and earn the billions that can come with it, the company has much more in the pipeline
Thus, ACXP may be entering a perfect storm of opportunity.
Collaborative Effort Targeting Gram-positive Infections
In collaboration with WuXi AppTec, ACXP is advancing an impressive preclinical development pipeline of antibiotic candidates targeting several other high-dollar treatment indications. And already, the two are in the late-stage processes of completing the manufacturing and formulation of ACX-375C to treat Gram-positive infections. That program holds tremendous value as well.
There, ACXP and WuXi will evaluate a DNA PolIIIC inhibitor, ACX-375C, to treat severe infections, including Staphylococcus, Streptococcus, and Enterococcal infections. Notably, Acurx already believes that early data shows promise for the drug to treat other G+ resistant bacterial infections, including VRE and MRSA, both highly debilitating and sometimes fatal conditions.
And like ibezapolstat, ACX-375C also targets multi-billion dollar market opportunities and is also expecting to replace decades-old standards of care. One indication with a big target on its back is MRSA, a potentially fatal, always debilitating, hospital-related infection that accounts for more than 52% of infections in hospitalized patients. Thus, if data extends the promise, also expect Big Pharma to potentially line up and take a look. Still, ACXP doesn't expect to stop at MRSA. They expect its drug candidate to be effective against multiple indications.
In fact, ACXP indicates that the drug may be effective in treating more general clinical indications, including urinary tract, hospital-acquired catheter/bloodstream, bone/joint, pneumonia, and ear and sinus infections. Thus, with numerous potential applications and multiple billion-dollar shots on revenue-generating goals, ACX-375C can also be a game-changing asset for the company. It just may take a little more time than its CDI program. But, with that said, positive developments with ACX-375C along the way can have a substantial impact on sector interest.
Hence, ACXP helps make the bottom line easy to understand: with drugs that can change the antibiotic landscape and target billion-dollar treatment indications, investors should pay attention. Moreover, data suggest that the ACXP share price today could change exponentially on its next announcement, following a precedent set in June.
A Back Half Of 2021 With Catalysts On Deck
Although ACXP reached a milestone when they came public in June, they are setting up to deliver a catalyst later this year. Potentially two. And with data supporting that they can deliver on that mission, combined with only about 9.9 million shares outstanding, positive data from its Phase2b trial could send share prices soaring. It's more than investor interest; it's a supply and demand issue as well. And, with not a whole lot of shares to go around, the best price wins....which is generally higher.
Moreover, any one of several updates from ACXP may fuel the flames of bullish sentiment. In the coming weeks, investors can look for interim trial updates, a filing for QIDP designation for ACX-375C, commencing its Pre-IND Pharm/Tox studies for ACX-375C, and seek fast-Track designation for ACX-375C as well. Best of all, data from its ibezapolstat trial could be the most significant catalyst of them all. Thus, the next few weeks may indeed be exciting times for both ACXP and its shareholders.
But the only way for investors to play is by owning stock. And at current levels, ACXP is presenting a compelling proposition.
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