In fact, the data presented for this FDA QIDP and Fast Track Designated for priority review candidate further validates its potential as a game-changing treatment for patients with debilitating infections, including its primary target, C. difficile. And the potentially better news is that ACXP is continuing to enroll patients in the Ph2b trial in up to 30 U.S. sites comparing the efficacy of ibezapolstat to the standard-of-care vancomycin. Results from those studies could put additional catalysts in the near-term crosshairs. But the here and now is worthy of attention.
ACXP also recently announced completing certain portions of its laboratory study at the
To date, ACXP's ibezapolstat is besting vancomycin on multiple fronts.
A Changing Of The Antibiotics Guard
But that shouldn't be surprising. Vancomycin is part of old-school antibiotics and is in a class of drugs that haven't changed in roughly forty years. And while it can provide at least some comfort to patients, it's far from being the type of drug needed- a curative one. And that's where ACXP's ibezapolstat differs.
The following is technical language, but it's excellent news for ACXP and its ongoing trial. Recent poster presentations assessed by qPCR and metagenomic sequencing analysis showed that colonic microbiome Firmicute bacterial populations consistently demonstrated preservation or increased abundance of Lachnospiraceae and Clostridiales throughout ibezapolstat treatment. That's advantage #1. There's more to like.
These emerging data also show that the potentially beneficial bacterial species from C. coccoidies and C. septum groups are preserved in healthy subjects and CDI patients during the dosing of ibezapolstat. This persistence or regrowth of healthy microbiota species is associated with beneficial physiologic effects such as maintaining secondary bile acids, which are known to protect against CDI recurrence. The data is earning praise.
In other words, ibezapolstat can be curative. No other known clinical trial candidate for treating C. difficile can make a similar claim. In fact, quite the contrary.
A Thinning Competitive Landscape Gives Advantage To ACXP
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 string of disappointing data includes that from
It's fair to point out that FNCH's Phase 2 data scored better than
ACXP's Ibezapolstat Shows 100% Curative Potential
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. More importantly, 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. They also justify 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.
Incidentally, 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. In other words, partnership deals could be in ACXP's future. Those not interested in collaborating may find competing exceptionally hard. So, who may want to partner with ACXP? Many might want to, but pharma giant
Is A Pfizer Partnership In The Crosshairs?
Actually, speculation is that
And keep in mind that PFE is blinded by unwarranted optimism about its CLOVER trial data. They are well aware the 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, certainly in play, 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 its drug and its stock.
Reasons for outside interest and appreciation are warranted.
A Best-In-Class Treatment Candidate
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.
There are other differences, which are also advantages. ACXP's 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
And the
A Massive Market Opportunity
If approved, ibezapolstat would likely meet overwhelming demand. A 2017 update of the Clinical Practice Guidelines for C. difficile infection by the
Other prestigious publications are also bullish on ibezapolstats potential. 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.
Under The Radar, But Maybe Not For Long
Thus, all tolled, ACXPs under the radar status may not last much longer. That means investment consideration at current levels is indeed warranted. In fact, trading ahead of the next data batch may be the wisest consideration, noting that small-cap biotechs can have quick changes in fortune. Another development-stage biotech, Actinium (NYSE-Amer: ATNM), is seeing its share price explode higher after reporting positive data in its ongoing trials. Like ACXP, they also target treatment for underserved and unmet medical needs.
Moreover, when small-cap biotechs have the potential to become large-caps, expect Big Pharma to pay much closer attention. They don't like competition. And to keep it at bay, they partner or acquire, either potential scenario boding well for ACXP. That could happen sooner than later.
Remember that valuations for a Phase 3 drug company compared to a Phase 2 can amount to hundreds of millions in difference. In other words, as ACXP approaches that milestone, they may already be in play and, at current prices, appreciably undervalued. Thus, as ACXP gets closer to making that leap and noting its trials are short in duration, expecting ACXP stock to move higher is a well-leveraged bet. In fact, rising about 10% in October, that bet is already paying off.
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