Acurx Pharmaceuticals was getting bullish interest at over $4.00. Now at $3.40ish, the herd should be pouncing. The interest is in ACXP's ibezapolostat, a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS™) antibacterial. While many potential new drugs show potential, this one can indeed be a game-changer in treating debilitating infections. And evidence of that ability is mounting.
Most recently, ACXP announced completing certain portions of its laboratory study at the University of Houston comparing the killing effect of ibezapolstat to vancomycin, fidaxomicin, and metronidazole using both in vitro and ex vivo analyses. The company presented some of those results at Anaerobe 2022, the Anaerobe Society of America annual scientific conference, which demonstrated that ibezapolstat has favorable killing kinetics compared to vancomycin to treat C. difficile infection at standard and high bacterial concentrations, supporting the continued development of a potential first-in-class antibiotic to treat C. difficile infection. Vancomycin is the current standard of care.
In addition to superior treatment potential, ibezapolstat is also the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to maintaining a healthy gut microbiome. That last part is a significant differentiator and is often the difference between cure and relapse.
Advancing A Phase 2b Trial Supported By Best-In-Class Data
Those new to ACXP should know that Phase 1 and Phase 2a clinical trials of ibezapolstat have been completed. Here's the excellent news: The Phase 2a trial demonstrated 100% clinical and 100% sustained clinical cures in patients with C. difficile Infection (CDI). That's not all. It also showed beneficial microbiome changes during treatment, including overgrowth of Actinobacteria and Firmicutes phylum species while on therapy and new findings demonstrating potentially beneficial effects on bile acid metabolism.
That data has helped expedite ACXP's move to a Phase 2b 64-patient, randomized (1-to-1), non-inferiority, double-blind trial of oral ibezapolstat compared to oral vancomycin, a standard of care to treat CDI. If results post as expected, ibezapolstat could quickly emerge as the first-line treatment for C. diff. That could happen sooner than later, noting that ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for treating patients with CDI.
ACXP can also benefit from the incentives for developing new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. Further, in January 2019, the FDA granted "Fast Track" designation to ibezapolstat for treating patients with CDI, positioning ACXP well to accelerate development and marketing to meet what the CDC has designated C. difficile as an urgent threat.
Demand Could Be Enormous
While grant money could be in play, the better news from an investor's perspective is that ACXP may be the last drug company standing in the race to get an effective C. difficile drug treatment to market. Keep in mind that ACXP isn't in the race to treat symptoms; it could have a cure. That difference is a critical distinction that other companies have so far failed to achieve. And there have been plenty of failures.
Over the past decade, disappointing clinical results in treating CDI have led several big pharma companies to drop off the clinical radar. Those still pursuing its CDI treatment candidate may be doing so with hopes of potentially treating, at best, niche indications of the infection. The latest disappointing data came from Pfizer (NYSE: PFE), who missed meeting its primary endpoints in its Phase 3 CLOVER trial to treat C. difficile. But they aren't the only ones disappointed.
Sanofi (NYSE: SNY) missed its endpoints in 2017, and more recently, Summit Therapeutics (NYSE: SMMT) published topline results that were far from impressive. Summit's miss resulted in them trying to change the primary endpoints in its Phase 3 trial, something the FDA didn't accommodate. Those three weren't the only ones disappointed to date. Another pharmaceutical company, Finch Therapeutics (NASDAQ: FNCH), saw a setback when it received a clinical hold letter from the FDA about concerns over its SARS-CoV-2 donor screening protocols. While Finch announced that the FDA hold was lifted and enrollment resuming in 2H 2022, they still lost considerable clinical momentum.
It's still fair to point out that FNCH's Phase 2 data scored better than Pfizer, Sanofi, and Summit. It showed that 80.3% of trial participants receiving a single administration of its candidate following standard-of-care antibiotics achieved sustained clinical cures through eight weeks. Impressive, yes. Compared to ACXP data? NO.
ACXP's Ibezapolstat Demonstrates 100% Success
Acurx's ibezapolstat candidate published Phase 2a data showing it to be significantly better. Compared to Finch's candidate, which focuses on the microbiome as a single dimension and has only demonstrated a reduction in recurrent infection, the most significant advantage and point of superiority of ibezapolstat are that it's a dual-impact drug that addresses the direct infection and, to date, avoids recurrent infection altogether. Better still, it restores the microbiome, a critical consideration.
The comparison to Finch's drug is appropriate because they may be the furthest along from a potential competitive perspective. Thus, the differences between the two candidates are timely. They also endorse a persuasive and data-justified argument that ACXP's candidate is seemingly better than Finch's one-dimension drug in cases of multiple recurrent infections. If that's the case, and current data points that way, ACXP's candidate could be the most ideally positioned treatment candidate to earn preferred first-line treatment designation.
Besides Finch's, no other candidate looks close to emerging as a serious competitive threat to ACXP's ibezapolstat's targeted front-line position. That's why others may need to pay to play; if they don't, they may find competing exceptionally hard.
So, who may want to partner with ACXP? Many might want to, but Pfizer (NYSE: PFE) may be the company to win ACXP's clinical trial heart.
Pfizer Would Be An Excellent Partner
Blogs are already speculating that Pfizer could be the first to call. And for good reasons. During its CLOVER trial update commentary, which missed primary endpoints, investors zeroed in on Pfizer expressing interest in staying committed to pursuing the over one billion dollar market opportunity. But interest and ability are two different clinical beings, and in the drug industry, only the latter matters.
And don't think PFE is blinded by unwarranted optimism about its CLOVER trial data. They are well aware its candidate failed to meet endpoints. It's also fair to suggest that they realize that if its candidate gets approved, it would likely be relegated to treating fringe and niche CDI treatment indications. Therefore, while no investor should put it past PFE to spend up to hundreds of millions of dollars more to advance and commercialize an unpromising drug, more savvy ones are considering PFE's best course of action may be to partner and potentially capture a significant portion of the entire billion-dollar market opportunity.
That consideration puts ACXP in a win-win scenario. Yes, grant funding can eliminate many obstacles. But partnerships can too. And while having partners can dilute earnings after marketing approval, they add immediate value, potentially eliminate all ongoing trial costs, and add a level of experience in getting drugs approved. For ACXP investors, the trade-off would be well worth the interest. However, it may not be as much as many think.
With best-in-class data, ACXP could bargain from a position of strength. Remember, its data supports the potential for ibezapolstat to become the front-line therapy to treat over 500,000 patients who get CDI yearly. Of those 500,000, more than 20,000 patients die per year. So, while using the term infection, don't underestimate its potential 4% outcome. CDI can be fatal. For ACXP, it can mean a significant appreciation for what it has and its stock.
ACXP Is Showing It Can Cure, Not Just Treat CDI
Why might ACXP's phone ring? Foremost, ACXP's Phase2a data showed 100% cure after 10 days of treatment and 100% sustained cure after a 30-day follow-up. Thus, the totality of data, even noting Finch's one-dimensional eight-week sustained cure, shows ACXP's Phase 2a data to date constitutes the best clinical data seen in the CDI space.
It also demonstrated restoration of the patient's microbiome during treatment, which is highly unusual for an antibiotic. Considering that, it's reasonable to consider ibezapolstat as a potential "dual impact" therapy because it restores the microbiome while tending to the acute infection. That's not all attracting attention.
Its Ph2a trial was so impressive that it led the Trial Oversight Committee and the Scientific Advisory Board to allow for early termination of its Phase 2a trial and advance straight into a Phase 2b study. That allowance was made after data on ten patients showed a 100% cure rate and 100% sustained cure after follow-up. In other words, those oversight boards probably liked what they saw.
The FDA may as well. They have already granted ACXP a Qualified Infectious Disease Product (QIDP) and a fast-track designation for its ibezapolstat treatment candidate. Perhaps it's fair to infer that they would be welcome to approve a drug that does exceedingly better than the current standard of care, Vancomycin, which has a recurrent infection rate of up to 40% with little evidence showing its value as an effective long-term treatment.
A Validated CDI Treatment Market
Once approved, ibezapolstat would likely meet overwhelming demand. A 2017 update of the Clinical Practice Guidelines for C. difficile infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA) indicates that C. difficile infection presents a significant problem to those in healthcare settings and among the general population. The disease is so prevalent in hospitals and long-term care facilities that the New England Journal of Medicine called C. difficile one of the most common causes of healthcare-associated infections in hospitals.
Acurx looks best positioned to meet the challenge. Data published from ACXP's Phase 2a trial in Clinical Infectious Diseases, one of the most respected journals in the medical community, indicates that ibezapolstat could be deserving of the front-line treatment crown. According to the article, ibezapolstat showed ideal traits as an oral antibiotics candidate, demonstrating a highly potent response against C. difficile, good tolerability, and limited gastrointestinal absorption. That resulted in very high fecal concentrations, which may reach three orders of magnitude above the MIC for C. difficile.
The article further noted that in addition to the ibezapolstat treatment being highly effective at killing C. difficile, it appears to do so while maintaining the populations of helpful bacteria in the gut microbiome. These signs indicate that the treatment may do more than cure CDI in the short term; it can significantly reduce the likelihood of recurrent infection.
Suitors May Call Sooner Than Later
That matters. In fact, there are a plethora of things that ACXP is showing to treat CDI that matter. And investors can bet that those following ACXP's clinical developments understand just how disruptive its ibezapolstat can be to treat CDI and as a means to usher in a new and better antibiotics candidate for other indications.
But under the radar ACXP isn't catching the mainstream attention it deserves. But that's not necessarily bad news. Investors can have an extended period to take advantage of a company doing the right things at the right time. And know this too. Big pharma is likely paying attention, as well, knowing that valuations of a Phase 3 drug company compared to a Phase 2 can amount to hundreds of millions in difference. Thus, as ACXP gets closer to making that leap, noting its trials are short in duration, expect ACXP stock to heat up as that opportunity nears.
In the meantime, those waiting for that progression could leave significant dollars on the table if a partnership announcement makes the headlines. Plenty of speculation suggests that with the data posted thus far, an engagement could happen sooner than later. If so, expect current prices to be gone in an instant. Significant interest in low-float companies has a way of adding tremendous value in a matter of minutes. With plenty to support that proposition, look at ACXP, therefore, as more than just a promising drug development; but also as a company where investment consideration is timely.
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