Acurx Pharmaceuticals (NASDAQ: ACXP) may be the best thing to happen to the antibiotics industry for more than 40 years. Why? Because they are among the few companies working to bring meaningful antibiotic treatment candidates to market, targeting massively underserved gram-positive infections. For patients, ACXP can be a life-saver.
And that's no exaggeration. 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.
But, there is good news on the horizon. ACXP is on an accelerating path to change the course of treatment by focusing on these gram-positive infections. Better still, they are one of the few companies entirely committed to bringing a better standard of care to the market. The more excellent news is that the industry is paying attention.
Health Holland recently granted $500,000 to ACXP in a collaborative venture to evaluate DNA Pol IIIC Inhibitors. Moreover, 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, regulators were so impressed by ACXP's Phase2a results to treat C. difficile that they allowed for early termination of that trial with a pass directly to a Phase2b study. Hence, being disruptive may have its advantages. And that could be excellent news for ACXP, patients, and investors.
Filling A Void Of Undeserved Development Attention
Keep in mind, too, that while Big Pharma is starting to rally together to help fund development and clinical-stage programs, others like Novartis (NYSE: NVS) and Sanofi (NASDAQ: SNY) have all but abandoned their antibiotics development programs. For them, the more cost-effective way to get better treatment to market is to acquire one. More simply, it's an ROI decision. However, their conservative approach creates both a strategic opportunity and a potential exclusive shot at a multi-billion dollar market for ACXP. That's the better takeaway.
Moreover, just because Big Pharma isn't in the clinic doesn't mean they don't appreciate the value smaller clinical-stage companies like ACXP can deliver. They may not have the ambition to develop specific products, but they certainly want part of the potentially massive revenues from nurturing a best-in-class alternative to the market. ACXP may have one they will need.
And with ACXP delivering stellar Phase2a trial results to treat EPI in patients with C. difficile, more focused attention could come sooner rather than later. If so, it's deserving. ACXP delivered compelling Phase2a data. So good, that as noted, regulators allowed for early termination of its Phase2a arm and allowed 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. Better still, ACXP is building a scalable platform. Thus, while C. difficile is today's intended target; the company believes many additional gram-positive indications can be targeted in follow-on studies.
And at a time when Chinese drug developers are said to be jealously protecting their antibiotics innovations and IP, ACXP is in the right market at the right time. More importantly, for the US markets alone, its clinical-stage programs are more than timely; they are critical to meeting the needs of the US population.
At The Right Market At The Right Time
Still, ACXP isn't just a clinical-stage company intending to help potentially millions of patients. They also provide a compelling investment proposition by being one of the only clinical-stage companies focused on changing the standard of care for C. difficile.
But, as mentioned, it's not accurate to evaluate ACXP as a one-drug wonder. Instead, data shows that leveraging 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.
For the here and now, though, ACXP's value comes through its intense focus on filling a void to treat C. difficile. And 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. They deserve to think big, by the way. Its Phase 2b study follows a 100% success rate in meeting primary and secondary trial endpoints from its prior trial arm. As noted, it was enough for regulators to expedite the trial. Hence, it's a nod that investors should embrace as well.
Perhaps best of all is that the trials are relatively short in duration, with most patients treated and evaluated over a 28-day cycle. Thus, catalysts are in play potentially before the end of this year.
Disrupting An Aged Market
And it's that near-term news that should keep ACXP investors attentive to the ACXP story. While a relative newcomer to the markets through an IPO in June, investors are starting to understand how ACXP can help change the antibiotics landscape. Their impression so far must be good. Even better, ACXP trial results are taking this company out from under the radar.
Deservedly so. Its phenomenal results from the Phase 2a segment of its C. difficile led to an early trial termination and a move directly to Phase2b studies. The ongoing trial evaluates ibezapolstat's effectiveness in treating C. difficile (CDI), a debilitating, weakening infection with symptoms including severe diarrhea and life-threatening colon inflammation.
It's a chronic and not uncommon infection. Worse, the CDI has been challenging drug developers to deliver a solution for decades, with no treatment to effectively battle its debilitating symptoms. At least until now. Topline interim data showed 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. Those results are leading to a standoff that could have significant implications for ACXP's share price.
Near-term, a head-to-head comparison is brewing with ibezapolstat set to battle the standard of care treatment Vancomycin. Knowing that that drug has an infection named after it (VRE) from its growing inability to overcome immune resistance, ACXP may be well-positioned to win that contest. Keep in mind, data shows that Vancomycin can leave a 40% chance of recurrence in patients once their treatment ends. Ibezapolstat doesn't. Hence, to investors that like to trade ahead of the news, ACXP's Phase 2b arm of the trial can fuel the mission to dethrone the current standard of care. That, indeed, is a potentially transformative event.
Moreover, if the final analysis shows that ibezapolstat performs better, expect ACXP shares to respond favorably. In fact, taking the crown from Vancomycin could have ACXP featured on the biotech talk shows in a hurry. Better yet, beating a drug market leader typically brings other perks, like a lucrative partnership or collaborative offers. Thus, watch the headlines. With these trials only weeks long in duration, a new potential standard of care could advance through the line of succession.
And while hopes are high for ibezapolstat, ACXP has plenty of additional clinical firepower in their quiver.
Pre-Clinical ACX-375C Takes On Additional Gram-Positive Infection
Acurx has another value-driving asset deserving attention, ACX-375C. And, like ibezapolstat, it too 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 also 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. And while interim data support that ACX-375C can be effective against those indications, ACXP expects its treatment profile to extend to numerous other gram-positive resistant bacterial infections.
In fact, similar to ibezapolstat, ACX-375C platform scalability could open its potential to treat numerous other infections beyond MRSA and VRE, including more common indications such as ear and sinus infections, urinary tract infections, bone/joint infections, and pneumonia.
Keep in mind, this program is in its pre-clinical investigatory stages. And while a $500,000 grant from Health Holland may help expedite the collaborative venture, investors should value this as an interim value kicker that will grow into its own valuation further down the development road. Still, long-term programs don't mean news deprived. The best practice is to stay focused on headlines. Obviously, Health Holland sees the potential.
More Than Disruptive- A Potential Life-Saver
And by posting $500,000 to the development effort, Health Holland likely recognizes ACXP's potential as more than an antibiotics drug developer. They perhaps also recognize the disruptive nature the company brings with it. If not, they should. After all, ACXP may be closer than most to delivering meaningful change to an antibiotics market in desperate need of new drugs. Moreover, it is positioning to deliver results not seen in roughly four decades.
Still, that's a marketing incentive. From an investment perspective, the proposition is equally compelling. Indeed, the value from ACXP posting exceptional Phase 2 data, targeting an antibiotics market in dire need of better drugs, and nearing a potentially transformative efficacy battle against the standard of care to treat C. difficile needs more attention. Frankly, like other peer biotech's, ACXP deserves a premium multiple ahead of updates. The great news there is that investors may be catching on.
Better still, technical analysis shows bullish signals. On August 17th, the stock was oversold at 19.39 RSI. Accordingly, the share price started to rise, and on August 20th, the MACD crossed to the upside, confirming the uptrend. Now, the more recent crossing of the technical indicators makes the case decidedly bullish, suggesting the share price could rise 37% to $6.82. That would be the level of next resistance at the 61.80% ratio. Thus, with shares closing higher daily since August 17th, the uptrend remains valid.
Moreover, if the results from its ongoing Phase 2b trial are as good as expected, T/A will likely give way to a massive bull run, making this first leg higher just the starting point for a more appropriate valuation. Indeed, ACXP may be getting fueled for takeoff.
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