Acurx Pharmaceuticals (NASDAQ: ACXP) remains one of the most promising under-the-radar companies in biotech. In fact, current ACXP share prices don't touch the surface of the revenue-generating opportunity at hand. In play is Acurx Pharmaceuticals potentially bringing to market a treatment drug that could capture the front-line position to treat one of the most debilitating infections known- C. difficile infection (CDI). And the better news, aside from patients finally getting effective treatment, is that ACXP appears to be the most promising drug candidate that remains in the running to lay claim to front-line therapy in the $1.6 billion CDI market. The rewards of doing so could be tremendous.
Herer's where the story gets more interesting. Despite its small-cap size, ACXP's drug candidate shows an ability to do what other companies’ drugs, including those representing Big Pharma, can't do- show treatment effectiveness. The latest miss comes from Pfizer (NYSE: PFE), who missed meeting primary endpoints in its CLOVER Phase 3 trial targeting CDI treatment. And their miss isn't the only one that positions ACXP to earn the front-line designation. Others didn't fare much better.
Sanofi (NYSE: SNY) (2017) and Summit Therapeutics (NYSE: SMMT) (2021) also published discouraging topline results from their clinical trials of attempted vaccines to treat or prevent CDI. And another pharmaceuticals company, Finch Therapeutics (NASDAQ: FNCH), announced a freeze in their Phase 3 trials enrollment resulting from a clinical hold letter from the FDA regarding concerns over the company's SARS-CoV-2 donor screening protocols. While obviously bad news for them in their quest to benefit from the lion's share of a $1.6 billionCDI treatment market, the competitor misfortunes do potentially bode well for Acurx.
Moreover, as the competitive landscape against a potentially approved ACXP drug shrinks, investors wanting exposure to the lucrative market opportunity may find the most expedient path to go through ACXP. After all, they continue to post best-in-class clinical trial results.
Best-In-Class Results, Different Action
And better than best-in-class, ACXP is differentiating itself from the competitive pack. For instance, in Finch's case, its candidate focuses on the microbiome as a single dimension and has shown only a reduction in recurrent infection – far less impressive than the elimination of recurrent infection as ACXP can boast from its Ph2a trial data. In contrast, ACXP's ibezapolstat is a dual impact drug that addresses the direct infection and avoids recurrent infection altogether (so far) while at the same time restoring the microbiome. Thus, in a side-by-side comparison, ACXP's candidate is seemingly better than Finch's one dimension drug in cases of multiple recurrent infection, making it potentially the only choice between the two for first-line treatment.
The opportunity gets better, at least for ACXP. PFE, SNY, and SMMT all reported unimpressive topline results from clinical trials of their competing treatments. And what's notable, and a testament to the value opportunity from the indication, is that these companies are still willing to fight to advance them. This is excellent news for ACXP and shows they are moving the right drug forward at the right time to address a significant and unmet market opportunity.
Actually, ACXP could find itself in companies' acquisition or licensing crosshairs, including Pfizer. They may have even tipped their hand to that effect, saying in its CLOVER trial update commentary that they are still interested in the billion-dollar-plus market opportunity. But, they probably also realize at the same time that they need a better candidate, especially with hopes of its drug becoming a front-line treatment all but evaporating based on its data set. Again, bad news for them could be excellent news for ACXP and its shareholders, especially if PFE wants to look beyond niche indications and potentially partner with a company showing a more than impressive data set.
Pfizer isn't exaggerating its diminished position, either. They are telling the markets they need a better option, noting in its press release about CLOVER that it intends to pivot toward treating high-risk and the most severe cases of CDI. This move keeps them in the game and allows them to leverage what they have to take advantage of revenue-generating opportunities in the "fringes" of the CDI treatment market. But, it likely keeps them from the big payday that PFE alluded to.
Pfizer's original assessment of its market potential for an approved vaccine used preventatively or as a front-line candidate and beyond is valued at over $1 billion. That estimate does at least two things. First, the market-size assessment validates the modeling generated by Acurx. And second, it exposes that a blockbuster drug is indeed in play.
Last Drug Candidate Standing
This, of course, is all excellent news for Acurx Pharmaceuticals and its investors. However, the most significant attraction to ACXP shouldn't be a result of others' failure but rather from ACXP's success. As it stands, AXCP has the potential to be one of the only companies to bring an effective CDI treatment to market. They could, in fact, be advancing what could become the front line therapy to treat patients in a $1.6 billion market in the U.S. alone. This would be excellent news for ACXP investors as well as for over 500,000 patients who get CDI each year (leading to death in approximately 20,000 patients per year).
Its Phase2a data showed 100% cure after 10 days of treatment and 100% sustained cure after a 30-day follow-up. If these data hold up in late stage trials including the ongoing Ph2b trial, it would constitute the best clinical data seen in the CDI space.
In addition, ACXP's CDI candidate demonstrates a restoration of the patient's microbiome during treatment, which is highly unusual for an antibiotic. Thus, management considers ibezapolstat somewhat of a "dual impact" therapy in that it restores the microbiome while tending to the acute infection. It's a differentiator worthy of competitor envy.
Entering Phase 2b With A Pristine Record
And deservedly so. The data from Ph2a further helped ACXP launch its Phase 2b trial enrollment without a hitch, keeping them as one of the only clinical-stage companies without a blemish on its record in treating the debilitating infection. But that's not all. In addition to ACXP's clinical success targeting CDI, they could also benefit from its ibezapolstat candidate showing a probability of possible changing for the better an antibiotics drug landscape that hasn't seen meaningful improvements in more than three decades. That could add a multiple to its ibezapolstat franchise.
In a single word, the data from its Ph2a trial was exceptional. In fact, it was so good 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. This decision was made after data on just ten patients showed a 100% cure rate and 100% sustained cure after follow-up when treating patients with C. difficile.
And know this, too- ACXP is better positioned today than at any time in its history to create substantial shareholder value in the near term. Thus, the stock's recent decline could offer an entry price too good to ignore. Moreover, there are reasons to pay attention.
CDI Treatment Mission Expedited With QIDP and Fast Track Designations
The FDA has already granted ACXP a Qualified Infectious Disease Product (QIDP) and a fast-track designation for the company's ibezapolstat treatment to accelerate the drug's path through trials and review. This is likely a recognition by the FDA that Vancomycin, the current standard of care for CDI, has a recurrent infection rate of up to 40%, meaning it is not as effective in long-term treatment.
Of course, efficacy matters, and ACXP is also checking that box. According to Robert J. DeLuccia, Executive Chairman of Acurx, "With the excellent clinical results and very good safety and tolerability demonstrated in the Phase 2a segment of this ongoing trial, we validated the bacterial pol IIIC enzyme as a therapeutic target for ibezapolstat, our first product candidate in our new class of antibiotics. Additionally, this trial segment showed potentially beneficial effects of ibezapolstat on the intestinal microbiome and bile acid metabolism."
This is high praise for ACXP's candidate, but investors need not rely on the company's opinion alone. As noted, objective data matters. And ACXP has plenty of good to boast about.
Phase 2a Clinical Trial Results Impress
The results from ibezapolstat's Phase 2a trial were impressive, to say the least. It was so compelling, in fact, that after monitoring patients for recurrent infection for 26 to 30 days, an assessment of the safety and efficacy of the Phase 2a treatment by the Trial Oversight Committee and the Scientific Advisory Board, which includes three of the leading infectious disease experts setting Infectious Disease Society of America (IDSA) treatment guidelines for C. difficile infection, recommended to terminate the Phase 2a trial early and move straight on to a Phase 2b trial. Given it was partially a panel of experts on C. difficile that issued this recommendation, it appears as though Acurx is capturing the attention of critical medical experts.
That's likely well deserved. Acurx Pharmaceuticals' ibezapolstat completed primary and secondary treatment objectives in trial patients with a 100% success rate, successfully curing C. difficile infection in all participants while preventing 100% of recurrent infections. Compared to the recurrent infection rate of up to 40% with the current standard of care for CDI, this result, as noted, is exceptional.
Also, keep in mind that an approved ibezapolstat will likely meet overwhelming demand. The 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 health-care-associated infections in hospitals.
As a matter of fact, C. difficile is estimated to cause over 500,000 infections each year in the United States, with about 20,000 of these cases being fatal. Across a sample of 150,000 patients, Acurx Pharmaceuticals estimates that the recurrence rates of three common treatments for CDI range between 20% and 40%. Overall, this means that C. difficile infections, climbing to an incidence of 600,000 with a high recurrence rate, are 9.3% fatal. If Acurx's treatment continues to post excellent results in its late stage trials, ibezapolstat could be a treatment that changes the lives of hundreds of thousands of patients.
That would be excellent news all around. And with ACXP expected to provide updates throughout 2022, added to its most recent saying that enrollment remains on track to complete by the end of this year, the path of least resistance to ACXP's valuation could be to the appreciable upside.
ACXP Could Change The Future of CDI Treatment- For The Better
Best of all, for ACXP, patients, and its investors, its ibezapolstat treatment shows mounting evidence to suggest that it may be the best option available to treat CDI and guard patients from recurrent infections. In other words, front-line status is in the crosshairs. Don't just take ACXP's word for it.
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 is well positioned to earn 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. The article also highlighted that the favorable early impressions are supported by ACXP's trial results, which found no recurrent infections in patients treated with ibezapolstat.
What's it all mean? In simplest terms, ACXP's trial data thus far indicates that ibezapolstat could be the much-needed first-in-class antibiotic to change the way C. difficile infection gets treated.
ACXP Preparing for an Extraordinary 2022 Following Phase 2b Trial
Thus, investors need to pay attention to what's happening at Acurx Pharmaceuticals. And they need to keep in mind its spotless data set across the company's ibezapolstat clinical trials, which becomes even more impressive when considering the failures of its most significant competitors. And that leaves, pending approval of its CDI treatment, Acurx to likely capture the lion's share of a more than $1 billion market opportunity.
Consider this too when evaluating the ACXP investment proposition. It's rare to see a biotech company publishing trial data as compelling as ACXP's to remain valued at under $100 million. And at roughly $26 million today, that suggests ACXP is more than appreciably undervalued; it's almost entirely disconnected from peer valuation reality.
But, some stocks tend to stay under the radar, and ACXP appears to be one of them. Still, these potential gems eventually get discovered, and corrections can happen quickly when they do. Thus, being on the sidelines on this trade could be leaving substantial dollars on the table. Almost certainly, a Phase 3 Acurx Pharmaceuticals will be valued substantially higher. While there may be time before that happens, prices this attractive may be a thing of the past.
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