Acurx Pharmaceuticals (NASDAQ: ACXP) is developing something for the antibiotics market that has been lacking since the 1980s- better drugs. In fact, flush with cash after its recent IPO, ACXP is accelerating its Phase2b trial utilizing ibezapolstat as a front-line treatment for C. difficile (CDI), a debilitating germ that causes severe diarrhea and colitis. Investors paying attention to the interim results from that trial helped send post-IPO prices higher by 45% to $8.74 intraday. The excellent news is that while value from that program may still be untapped, so is the value from its other development and clinical-stage programs. And those could set up a strong back half to 2021.
In fact, ACXP is advancing a compelling preclinical development program for potential new antibiotic candidates in scientific collaboration with WuXi AppTec. They are also in the late-stage processes of completing manufacturing and formulation of ACX-375C to treat Gram-positive infections, two more likely reasons why investors sent share prices soaring. And while share prices have settled back toward their $6.00 IPO range, not uncommon as underwriters take profits, the bullish sentiment overall remains exceptionally bullish. In fact, any weakness in share price ahead of expected interim updates could present a buying opportunity.
And the better news is that updates could be imminent, with ACXP expected to deliver trial updates before the end of this year. Thus, trading ahead of what has already been stellar trial news may be a wise consideration.
Targeting CDI and Gram-Positive Bacteria
In fact, its Phase2a trial data using ibezapolstat in patients with CDI showed a 100% cure rate and 100% sustained clinical cure after 30 days of treatment. Even better, ACXP believes that the results show an opportunity to leverage the drug applications to target other antibiotic development opportunities created by COVID-19. And that effort is timely as policymakers and clinical investigators now grapple with the surging Delta variant that infects global populations at an alarming rate. In fact, international attention is more focused than ever to sponsor developing a new class of therapeutics that can meet the challenges of antibiotic-resistant conditions built over the past four decades.
Still, while new treatments for COVID-related illness is in sharp focus, investors are correct to pay attention to ACXP's ongoing trials. In fact, data from its Phase 2a trial suggests that the company is well on its way to replace the current standard of care treating CDI. Current treatments leave a high burden of C. difficile in the gut that often leads to recurrence of CDI in up to 40% of patients once their therapy stops. ACXP's alternative shows quite the opposite effect.
In fact, the trial results so impressive that regulators allowed for early termination of segment 2a and approved direct advancement to a Phase 2b trial. That study arm is designed to treat 64 patients over 10 days, with 32 patients dosed ibezapolstat and the remaining 32 patients dosed with Vancomycin, the current standard of care. The excellent news here is that if ibezapolstat can best the market leader, ACXP could be positioned to capitalize on several early opportunities, including substantial partnerships and licensing opportunity interests. Perhaps best of all from a timing perspective is that with the treatment lasting only 10 days, interim updates could provide catalysts ahead of final top-line results.
CDI Market Demanding A Better Standard Of Care
Also valuable to the program is that CDI patients are demanding a better standard of care. More than debilitating, CDI has a mortality rate of 9.3% and an exceptionally high level of recurrence. Thus, ACXP is more than timely; they are on track to develop a potentially life-saving drug to market as well.
Already, its Phase2a results treating patients with mild to moderate CDI with orally administered ibezapolstat showed best-in-class results. In fact, ACXP met both primary endpoints of its trial, with all patients dosed with 450mg twice daily for 10 days meeting primary and secondary efficacy endpoints of initial cure and sustained cure. Notably, the treatment was well-tolerated, with no severe adverse reactions reported.
And that's great news, especially with the CDI market presenting a more than $1.2 billion opportunity. However, while meeting a high-value unmet medical need today, that market is expected to grow by 41% by 2026 to a more than $1.7 billion treatment opportunity.
Best of all, from a timing perspective, by utilizing DNA polymerase IIIC inhibitors, ACXP is already positioned to deliver a first-line treatment to patients with C. difficile, a market that the CDC and CDI classify as an urgent threat requiring new antibiotic development. Most important, encouraging data suggest that its drug could be the first to replace decades-old antibiotics with recurrent infection rates of between 20% - 40%.
Thus, expect the FDA and other regulatory agencies to pay special attention to the developments at ACXP. And with its potential to treat COVID and post-COVID infections, that interest may come sooner rather than later.
Another Valuable Asset In ACX-375C
Another development stage program earning substantial attention is its DNA PolIIIC inhibitor, ACX-375C, targeting severe infections, including Staphylococcus, Streptococcus, and Enterococcal infections. Acurx has also indicated that this drug may also be ideal for treating other G+ resistant bacterial infections, including VRE and MRSA, both highly debilitating and sometimes fatal infections.
Like its CDI treatment candidate, ACX-375C targets a multi-billion dollar market opportunity as well. It also is intending to replace decades-old standards of care. And with MRSA accounting for more than 52% of infections in hospitalized patients, ACXP is again timely in working to develop a life-saving alternative for patients. Still, beyond its importance to treat MRSA and VRE, ACXP expects the drug to be effective in treating more general clinical indications, including urinary tract, hospital-acquired catheter/bloodstream, bone/joint, pneumonia, and ear and sinus infections. Thus, with numerous potential applications and multiple billion-dollar shots on revenue-generating goals, ACX-375C can be a game-changing asset for the company.
Better still, both of its antibiotic drug candidates are eligible to earn Qualified Infectious Disease Product (QIDP) and Fast-Track designation. In fact, with ibezapolstat showing itself to be a better treatment option compared to Vancomycin, it is indeed qualified to receive specific designations. And keeping in mind that, unlike Vancomycin, ibezapolstat showed no reduction in healthy bacteria, was poorly soluble in the gut (a positive), and had free concentrations of ibezapolstat high enough to kill C. difficile but too low to kill healthy bacteria, it could earn expedited review sooner rather than later.
Thus, potential near-term catalysts are in view. Moreover, the combined value from its development and clinical-stage programs make the investment proposition compelling for both short and long-term investors.
Expecting A Surge In 2H 2021
Undoubtedly, the strength of its IPO showed that investors were paying attention to ACXP's debut. And with only about 9.5 million shares outstanding, the stock is set up to gain substantially in value if milestones are reached. Therefore, although shares can be volatile due to their tight float, the long-term implications are decidedly bullish, especially with Phase2a data showing remarkable results.
Best of all, although new to the public markets, ACXP is already positioned to deliver several near-term catalysts to investors. In short order, ACXP plans to file for QIDP designation for ACX-375C, start its Pre-IND Pharm/Tox studies for ACX-375C, file an IND, and seek fast-Track designation for ACX-375C as well.
Thus, the next few weeks and months could provide a catalyst-fueled surge for the stock. And if that's the case, trading ahead of the news may be a wise investment strategy.
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