Acurx Pharmaceuticals (NASDAQ: ACXP) reached another milestone on Thursday after announcing expected inclusion into the Russell Microcap® Index later this month. The preliminary list of new members was posted on Wednesday and is expected to add substantially to ACXP's institutional exposure over the next year.
More than that, it's a solid reflection of ACXP's ongoing achievement of its drug development objectives for its pipeline of DNA polymerase IIIC inhibitors. Better still, if its pipeline candidates get approved, they would deliver the first of a new class of antibiotics in over 30 years.
And progress in reaching that goal is making significant strides, with ACXP continuing its work towards completing the clinical development program for its lead antibiotic candidate ibezapolstat, targeting the treatment of C. difficile Infection. Investors should expect ACXP to announce reaching several key milestone catalysts on that program through 2021 and 2022.
The more excellent news is that the Russell inclusion adds to several positive milestones already reached. Beyond making advancements not seen in decades, ACXP is also among the few companies working to bring meaningful antibiotic treatment candidates to market that target massively underserved gram-positive infections. For patients, ACXP can be a life-saver. For investors, it can be a value driver to portfolios.
Going After Gram-Positive Infections
ACXP is in the right market at the right time. Gram-positive infections range from MRSA, which accounts for 52% of hospitalized patients, to VRE, a condition that has become highly resistant to the current standard of care treatment Vancomycin. Both can be debilitating. Worse yet, they can sometimes be fatal.
While they can be devastating infections, the good news is that ACXP is taking action to fill a void. They are also getting industry attention, with Health Holland recently providing $500,000 to ACXP in a collaborative venture to evaluate DNA Pol IIIC Inhibitors.
Further, industry-wide calls from the CDC, NIH, BARDA, and CARB-X to treat these underserved infections are getting louder, resulting in potentially more grant funding in the near term. But it's not just the industry agencies paying attention; regulators are too.
In fact, ACXP's Phase2a results to treat C. difficile were so compelling that regulators allowed for early termination of that trial with a pass directly to a Phase2b study. Hence, ACXP is proving that being disruptive brings advantages. Moving toward its Phase 2b and Phase 3 trial, that could be excellent news for ACXP, patients, and investors.
Stay Interested In The Near And Long Term Proposition
Indeed, Acurx's data is impressive. They delivered excellent topline Phase2a trial results to treat EPI in patients with C. difficile. As noted, the results enticed regulators to allow for early termination of its Phase2a arm and a move directly into its Phase 2b study. That allowance saves time, money, and resources. It also highlights that ACXP took a giant step closer to getting an effective treatment for EPI in patients with C. difficile to market.
Even better, if its Phase 2b trial confirms prior results, ACXP could find itself advancing into a Phase 3 trial with best-in-class front-line treatment expectations. ACXP expects to do just that, following its Phase 2a study that demonstrated a 100% success rate in meeting primary and secondary trial endpoints. And with the trial relatively short in duration, with most patients treated and evaluated over a 28-day cycle, that news can come soon. Thus, catalysts are in play.
But, as compelling as its C. difficile treatment candidate is, don't think of ACXP as a one-drug opportunity. Instead, consider too that data shows its scalable platform can potentially expedite the creation of other drugs to treat additional gram-positive infections.
Those markets are substantial and also come with an inherent and urgent medical need.
Disrupting Antibiotics Markets In Need Of New Drugs
Its ACX-375C program is also in play. Like ibezapolstat, it intends to earn front-line and best-in-class effectiveness. Early indicators already show potential to counter numerous multi-drug resistant (MDR) and sensitive gram-positive bacterial pathogens. Indeed, despite its pre-clinical status, data shows promise and a reason to pay attention.
The pre-clinical program is a collaborative effort with WuXi App Tec and is one of the few studies evaluating the DNA Pol IIIC inhibitor to treat multiple infections, including Staphylococcus, Streptococcus, and Enterococcal infections. Interim data support that ACX-375C can be effective against more than only those indications, and ACXP expects its treatment profile to extend to numerous other gram-positive resistant bacterial infections.
In fact, ACX-375C platform scalability could open its potential to treat numerous other infections beyond MRSA, VRE, and those mentioned above, including more common indications such as ear and sinus infections, urinary tract infections, bone/joint infections, and pneumonia. Its $500,000 grant from Health Holland may help expedite the collaborative venture. Still, while this program may take into 2022 to get into a more formal clinical setting, updates would be interim value drivers.
Hence, watch for headlines on the program.
Back Half Of 2021
Inclusion into the Russell is a value driver that shouldn't
go unnoticed. The better news is that it adds to the value brought through its other programs. And with the technicals showing ACXP ready to bounce higher after reversing off oversold conditions, the remainder of this year looks attractive from both a company and an investor's perspective.
And a move higher is well-deserved. ACXP has posted exceptional Phase 2 results in its C. difficile trial, earned expedited advancement to a Phase 2b study, banked grant money to support its trials, and positioned itself to deliver best-in-class front-line treatments to market. That's a four-fold of reasons to like the stock today.
Moreover, if results from its late-stage Phase 2b trial are as good as expected, don't look to T/A for guidance. The stock will likely ramp considerably higher without the charts, making this recent 12% move higher the launching pad for a more appropriate valuation.
Undoubtedly, ACXP is a stock that should be in investor's crosshairs. The better strategy, however, may be to pull the investment trigger sooner rather than later.
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