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,
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.
Another pharmaceutical company,
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
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
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
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
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
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.
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
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
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