In fact, data published to date continues to validate this FDA QIDP and Fast Track Designated for priority review candidate as a potentially life-saving treatment for patients with debilitating infections, including its primary target, C. difficile. And with ACXP 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, that much-desired result could be brought to market sooner than later. If so, and with support from regulatory agencies to expedite reviews, the milestones within ACXP's crosshairs may soon become catalysts for significant growth.
That argument is gaining strength, especially after ACXP recently announced completing certain portions of its laboratory study at the
Those findings greatly support the continued development of ibezapolstat as a potential first-in-class antibiotic to treat C. difficile infection, with ACXP's candidate demonstrating the ability to possibly best vancomycin as a new standard of care.
A Changing Of The Antibiotics Guard
Such a result shouldn't be surprising. Vancomycin is an old-school antibiotic, existing within a class of drugs that haven't changed in roughly forty years. And while these decades-old drugs can provide at least some comfort to patients, most, if not all, are far from being the type of drug needed - a curative one. That's the gap ACXP's ibezapolstat wants to fill.
And it very well may. 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. While that's indeed medical speak, consider it as advantage #1. There are others.
The 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 attracting attention and earning praise.
More simply stated, ibezapolstat is showing potential to be a curative treatment. To date, no other clinical trial candidate for treating C. difficile can make a similar claim, and most competing trials are missing endpoints.
Advantage Shifts To ACXP For Treating C. difficle
In fact, some aren't even reaching interim endpoints, with disappointing clinical results causing many big pharma companies wanting to treat C. diff to drop off the clinical radar. Some are still pursuing its CDI treatment candidate, but with hopes shifting to 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
Ibezapolstat Shows 100% Curative Potential
Acurx's ibezapolstat candidate published Phase 2a data showing it to be more than different in its action; comparative results were 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 of ibezapolstat is that it's a dual-impact drug that addresses the direct infection and, so far, 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. It also raises 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, which current data supports, 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 generated speculation that some clinical rivals may be more inclined to pay to play. In other words, partnership deals could be in ACXP's future. So, who might want to partner with ACXP? Many point to pharma giant
A Pfizer Partnership Makes Sense
Such a deal makes sense, and investors have excellent reasons to believe it could happen. During
And they should. In addition to failing to meet primary endpoints, the data that was good likely relegates it to treating fringe and niche CDI treatment indications at best. Therefore, while there's no guarantee that PFE won't spend up to hundreds of millions of dollars more to advance and commercialize an unpromising drug, it's fair to suggest that the more prudent course of action may be to partner up with a company already demonstrating more impressive results. Doing so may bring a much greater potential to capture a significant portion of the billion-dollar market opportunity.
That scenario, at the very least, presents ACXP with a win-win proposition. It can also accelerate ACXP's clinical ambitions. Yes, grant funding, certainly in play, can eliminate many obstacles. But Big Pharma partnerships can too. And while collaborations can dilute earnings after marketing approval, they most often add immediate value, including significant upfront payments and covering the cost of ongoing trials. Best of all, though, they add a level of experience in getting drugs approved, which for ACXP, patients, and investors, may be well worth conceding part of the income potential. Still, don't assume that ACXP will need to give up too much striking a deal.
Best-in-class data allows ACXP to bargain from a place 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. But keep this in mind when appraising ibezapolstat's potential.
A New Class Of DNA Polymerase IIIC Inhibitors
In addition to superior treatment potential, ibezapolstat is also the first of a new class of DNA polymerase IIIC inhibitors under development by ACXP to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes targeting 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, big ones, that enhance ibezapolstats value proposition. 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 Drug That Would Meet Overwhelming Demand
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 ibezapolstat's 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.
Deservedly Emerging From Under The Radar
All totaled, the ACXP value proposition, considering the accumulated data to treat a compelling need, might be too good to ignore. In fact, further data could very well change ACXP from an under-the-radar small-cap biotech into a popular and sought-after partner. At roughly
Keep this in mind, too, as it applies to ACXP's current position. Valuations for a Phase 3 drug company compared to a Phase 2 can amount to hundreds of millions in difference. In other words, with data supporting ACXP to reach that milestone, potential suitors or partners may come calling before the expected jump. Some volatile trading suggests that positions may already be in the process of getting built.
If so, and as ACXP gets closer to becoming a Phase 3 pharmaceutical company, a tighter share float and increased interest could make an appreciable move stronger. In other words, while the roughly 10% spike in October is impressive, the best may be yet to come.
Disclaimers:
The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled.
Media Contact
Company
Contact Person:
Email: info@hawkpointmedia.com
Phone: 3057806988
City:
State:
Country:
Website: https://level3trading.com
.
(C) 2022 M2 COMMUNICATIONS, source