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Pfizer’s CDI Trial Miss Puts Acurx Pharmaceuticals Ibezapolstat In Front-Line Position, Here’s Why Big Pharma May Come Calling ($ACXP)

Finding an effective treatment against C. difficile has been challenging, with the past few decades serving up little more than short-term relief from CDI's debilitating symptoms. But, one micro-cap company, Acurx Pharmaceuticals (NASDAQ: ACXP), is on the right path to changing the treatment landscape with its CDI treatment drug candidate showing best-in-class front-line treatment potential. 

In fact, data is more than good; its ibezapolstat candidate demonstrates things that others can't... overwhelmingly positive results that treat debilitating CDI symptoms and deliver a more vital interim result- it can cure the infection. And that distinction may have ACXP on the radar screens of several of the Big Pharma players.

From Under The Radar To Blinking Bright

That presence is well deserved and well-timed. Acurx Pharmaceuticals, after all, could be the last company standing in a race to capture the lion's share of the estimated $1.6 billion CDI treatment market opportunity. The better news for ACXP to make that happen is that several potential competitors have dropped off the clinical radar over the past decade, with each relegated to potentially treating, at best, niche indications of the infection. The latest disappointing data came from Pfizer (NYSE: PFE), which missed meeting its primary endpoints in its Phase 3 CLOVER trial to treat C. diff. But they aren't the only ones licking their wounds. 

Sanofi (NYSE: SNY) missed its endpoints back in 2017, and more recently, Summit Therapeutics (NYSE: SMMT) published topline results that were far from impressive. In fact, that 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 that enrollment would resume in 2H 2022, they still lost considerable clinical momentum. It's appropriate to note that FNCH's Phase 2 data was impressive compared to 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 cure through eight weeks. Promising, yes. Better than ACXP? No. 

Better Data, Dual Action

Acurx's candidate published Phase 2a data that appears to be significantly better. The most significant advantage could be that compared to Finch's candidate, which focuses on the microbiome as a single dimension and has shown only a reduction in recurrent infection, ACXP's ibezapolstat is a dual impact drug that addresses the direct infection and, to date, avoids recurrent infection altogether. Not only that, it restores the microbiome, a critical consideration. 

That difference alone endorses 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, ACXP's candidate checks additional boxes to become the preferred first-line treatment. And other than Finchs', no other candidate looks close to emerging as a serious threat to ACXP's ibezapolstat's intended front-line position. 

That's potentially excellent news for ACXP. And it's the reason why ACXP could already be on Big Pharma's shortlist for acquisition or licensing terms to earn the lion's share of a lucrative market opportunity. 

Big Pharma Dialing?

Speculation is that Pfizer could be the first to call. Investors are zeroed in on Pfizer clearly expressing their interest in pursuing the over one billion dollar market opportunity during its CLOVER trial update commentary. Still, interest and ability are two different clinical beings, and in the drug industry, only the latter matters. 

With that said, don't think PFE is blinded by unwarranted optimism. They know its candidate failed to meet endpoints. Moreover, they likely know, at best, its candidate, if approved, would be relegated to treating fringe and niche CDI treatment indications. Therefore, spending potentially hundreds of millions of dollars more to advance an unpromising drug candidate makes little to no sense. 

What does make sense is for deep-pocketed Pfizer to cozy up with the presumed CDI treatment drug frontrunner. In this case, with data supporting the presumption, Acurx is the likely recipient of their first call. Remember that PFE doesn't invest billions to earn a backstage pass. Instead, history indicates that what they can't produce, they acquire. And with ACXP showing evidentiary promise as one of the only companies left to bring an effective and comprehensive CDI treatment to market, it may be wise to consider a fair price for its lead asset. 

Better news on that front for ACXP and investors is that the price point could be hefty, with ACXP bargaining from a position of strength. Remember, data supports the potential for ibezapolstat to become the front-line therapy to treat over 500,000 patients who get CDI each year. Of those 500,000, more than 20,000 patients per year die. So, while the term infection is used, don't underestimate its potential 4% outcome. CDI can be fatal.

Race For A CDI Cure

It's why the race to find a treatment, better yet, a cure for CDI, is a persistent pursuit. And that's precisely what ACXP may be serving up. So don't think Pfizer calling on Acurx is overly speculative. They would be dialing because 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. 

Also strengthening its likelihood of earning front-line status, ACXP's CDI candidate demonstrates 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. 

More in ACXP's favor and likely attracting industry attention is that the data from 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. Furthermore, that jump was allowed after data on just ten patients showed a 100% cure rate and 100% sustained cure after follow-up. 

They save time and resources from that allowance. They benefit further from the FDA already granting ACXP a Qualified Infectious Disease Product (QIDP) and a fast-track designation for the company's ibezapolstat treatment. Interest in their getting a better drug to market faster could stem from knowing 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.

Don't Forget The Value From Massive Demand

Also, keep in mind that an approved ibezapolstat will 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 health-care-associated infections in hospitals.

While there is already a plethora of company-published data to support and attract interest, there's more to consider. And it's again favorable to ACXP. 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. 

Will Suitor's Come A Callin'?

What's it all mean? Put simply, ACXP could be in play. Moreover, things could move quickly, noting that the cost to partner with a Phase 2 company over a Phase 3 company can amount to hundreds of millions of dollars. Yes, hundreds of millions. Just look at before and after market cap shots of companies making that leap. It's a valid indication of how valuable being a Phase 3 trial with compelling, best-in-class data can be. 

The bottom line... Acurx is in the right place with the most promising CDI treatment drug to make a deal. And while several companies may be interested near-term to partner or license, the chatter centers around Pfizer being the ideal and most likely suitor. 

If so, whether in Phase 2 or Phase 3, ACXP investors could be in for an exciting ride in 2022. Catching that action from the inside and looking out may be the better place to reside. After all, what may be considered chump change from Pfizer, or another pharma player, would be a windfall for Acurx Pharmaceuticals and its investors. And the way things could play out, both may get that benefit. 



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