Acurx Pharmaceuticals Inc. (NASDAQ: ACXP) earned a 12-month price target of $12 from analysts at Maxim Group. Coverage was initiated with a BUY rating, and its price target covering the next twelve months. Shares traded higher by roughly 3.5% to $5.06 on double its average volume.
Acurx Pharmaceuticals is finding its place as a potential disruptor to an antibiotics manufacturing sector that has been quiet for nearly four decades. The goal is simple- change the current antibiotics landscape by bringing products and services targeting unmet needs to market. As Maxim noted, that plan is already in motion.
Acurx has established 12 clinical trial sites, which have been activated to commence enrollment of the Company’s Phase 2b clinical trial of patients with C difficile infection (CDI). Enrollment is expected to be completed in the second quarter of 2022 to evaluate ibezapolstat as a treatment for millions of patients suffering from C. difficile. Results from its 2a arm indicate the drug to be a potential best-in-class front-line treatment. In fact, Phase 2a results were impressive enough that an independent scientific review board agreed with a decision allowing ACXP to terminate its Phase2a trial early because of overwhelmingly positive data.
Ibezapolstat Earning Interest
In fact, Phase 2a trial data demonstrate potential best-in-class efficacy. It delivered a 100% cure and 100% sustained cure, with no relapse ever. Moreover, every indication to date suggests that ibezapolstat is positioning to become the undisputed front-line treatment against C. difficile. Here’s why:
Foremost, ibezapolstat demonstrated its ability to eradicate C. difficile in the GI tract within 72 hours of treatment. Sometimes in as little as 24 hours after dosing. And that’s not all. It did more than treat the infection; it also killed the host cell.
Thus, as noted, the results led to an independent scientific advisory board agreeing with a recommendation allowing ACXP to terminate its Phase2a trial early. That decision should not be surprising, especially with a 100% positive patient response (sustained cure) and no relapse after follow-up evaluations. Furthermore, recent posters presented at the recent World Antimicrobial Resistance conference added more context to its best-in-class profile.
There, posters showed ibezapolstat potentially superior in a side by side comparison to current treatment Vancomycin. First, ibezapolstat only attacks and kills what it’s supposed to kill. That means that despite its potent activity, it leaves healthy microbiota alone to continue to do their jobs. Killing them, which other treatments do, can often complicate matters worse than C. diff itself. On that basis alone, even if ibezapolstat was only as effective as Vancomycin, ibezapolstat should earn approval. However, that’s not the case. As noted, it showed 100% effectiveness in cure and sustained cure, which instead should jump it to a front-line treatment. Still, ACXP took things a step further.
They completed a small study of healthy volunteers (non-CDI), with resulting data giving ACXP an advanced understanding of the microbiome and CDI pathophysiology. Better still, data indicates that from a pharmacokinetics, microbiology, and systems biology perspective, ibezapolstat is checking off all the right boxes. In short, data, including its better effects on bile acids, is doing everything it should to justify its case as a go-to antibiotic treatment against C. difficile.
Of course, with its Phase 2b trial soon starting, ACXP is looking to confirm its stellar Phase2a results. And with a 28-day treatment cycle and review, ACXP could have topline results to share in mid-2022. Even better, assuming its Phase 2b trial confirms Phase 2a topline data, ACXP could find itself entering into a Phase 3 study with best-in-class front-line treatment potential. The prize- a chance to seize the lion’s share of a multi-billion C. diff treatment market.
For investors, taking advantage of current share prices may be a gift that keeps giving this holiday season. Maxim is bullish, and they did their homework. Hence, ACXP will likely continue to attract positive attention.
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