Following a period of bearish conditions, investors are anxiously awaiting the next big rally. A return to normal levels would help revitalize investor portfolios and confidence following a difficult month for the markets. However, the return to bullish conditions may come sooner than many may believe –especially for those companies that navigated the situation wisely. Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) is one of those companies that have consistently pushed through its clinical trials and are beginning to post the results that could send them back to all time highs. And, with ACXP closing out 2021 as a year filled with some of its most significant developments yet, a rally may very well be within reach.
In fact, this rally may be even closer than many may think. ACXP's stock soared more than 10% as the company achieved yet another milestone in its quest to bring a new and much-needed C. difficile treatment to market. In that development, the company announced that the first patient had been enrolled in a Phase 2b clinical trial comparing ibezapolstat, its primary antibiotic candidate, to vancomycin, the current standard of care for CDI. For most biotechs, this would be the first of thousands of patients required to move the trial forward. This isn’t the case for ACXP, however - only 64 patients are needed for the trial, and they will be easy to come by now that the pandemic is substantially behind us.
Due to C. difficile's debilitating symptoms and the fact that there is currently no therapy on the market that can successfully manage them without recurrent infection, enrolling patients in the cohort is unlikely to be a challenge outside of the COVID-19 pandemic. In fact, patients might be eager to join the program after learning of its current potential. ACXP’s trial has already demonstrated fantastic Phase 2a results, boasting a 100% cure rate that also remained 100% sustained in follow-up examinations. This is an unrivaled achievement that no other C. difficile treatment has been able to accomplish as of yet albeit in a small subset of 10 patients.
On February 7th, 2022, the full results from its Phase 2a trial were published in Clinical Infectious Diseases, an official publication of the Infectious Disease Society of America that is one of the most cited journals in the field. Senior author of the publication, Dr. Kevin Garey, had much to say about the promising potential of the novel antibiotic. Dr. Garey noted that ibezapolstat is demonstrating the ideal properties of an oral antibiotic for CDI: “highly potent against C. difficile; good tolerability; and limited gastrointestinal absorption, resulting in very high fecal concentrations which may reach three orders of magnitude above the MIC for C. difficile.” He added that not only does Ibezapolstat appear to eradicate C. difficile in just three days of treatment; it also seems to spare other important bacteria that are necessary in maintaining a healthy microbiome. All of these properties indicate that ibezapolstat could significantly reduce the likelihood of CDI recurrence, a property that no other available treatment has been able to reliably achieve.
Simply put, ACXP’s candidate could offer an unrivaled improvement upon the way CDI is currently treated. In fact, the trial's findings were so intriguing that an independent Data Oversight Committee advised the business to terminate the Phase 2a trial early and jump right into Phase 2b. Phase 2b is now underway, and even more promising results could be posted in the near future.
Ibezapolstat’s Fast-Track and QIDP Designations Make a for a Timely Consideration
The success of its Phase 2a trial has already made waves in the industry. Other regulatory agencies also are joining in to help get a better drug to market, with the FDA granting its ibezapolstat candidate QIDP and Fast Track Designations to prioritize review. The goal is to replace vancomycin, a C. diff medication that only provides temporary relief and has a 20-40% recurrence rate in many instances. And, if the Phase 2a results are any indication, ACXP's ibezapolstat could significantly improve patient outcomes compared to other marketed therapies to treat patients with C. difficile.
Should results from its Phase 2b trial continue to affirm ibezapolstat’s potential as a front-line C. diff treatment, ACXP stock could see a substantial increasein valuation. Even better, confirmatory data could present several financial opportunities in addition to ibezapolstat's inherent value, with legislation such as the Pasteur Act and a Big Pharma investment program potentially providing an avenue to substantialfunding to help facilitate quicker development. Most importantly, with C. difficile bacteria ranking high on the CDC’s Urgent Threat list and being the first of an entirely new class of antibiotics, ibezapolstat has reason to spark significant interest from the industry. As a result, ACXP could potentially receive a great amount of assistance in bringing this life-saving drug to market.
The even better news is that ACXP is paving the way in bringing ibezapolstat through the rest of its clinical trials, and they aren't afraid to express their firm belief in its potential. Robert J. DeLuccia, Executive Chairman of Acurx, said, "With the excellent clinical results and very good safety and tolerability demonstrated in the Phase 2a segment of this ongoing trial, we validated the bacterial pol IIIC enzyme as a therapeutic target for ibezapolstat, our first product candidate in our new class of antibiotics. Additionally, this trial segment showed potentially beneficial effects of ibezapolstat on the intestinal microbiome and bile acid metabolism."
Investors don’t need to rely on the word of ACXP alone, however – their clinical trial results speak for themselves.
ACXP Impresses Key Scientific Advisory Board Members; Moves Straight to Phase 2b Trial
As previously described, the results from ibezapolstat’s Phase 2a clinical trial are showing unmatched potential in the treatment of CDI compared to currently available options. To summarize the study, the Phase 2a segment enrolled and treated 10 subjects from study centers in the United States with diarrhea caused by C. difficile. Those patients were treated with ibezapolstat 450 mg orally, twice daily for 10 days, and each was followed for recurrence for 28± 2 days. Here’s where the story becomes intriguing. After the Trial Oversight Committee and Scientific Advisory Board assessed the safety, tolerability, and efficacy of the Phase 2a study after 10 of the projected 20 patients completed treatment, they recommended an early termination of the Phase 2a study in order to move directly to a Phase 2b trial. Note that the Scientific Advisory Board includes the three infectious disease experts that write the IDSA treatment guidelines for C difficile, indicating that ACXP’s candidate is catching the attention of regulatory experts.
Not only is it catching attention from critical parties, but it’s gaining support as well. After assessing results from just 10 of the 20 patients who were scheduled to be treated, the Scientific Advisory Board (SAB) and Trial Oversight Committee made a unanimous decision to close the Phase 2a trial early and move right into Phase 2b. To put it another way, they only needed to witness half of the expected results to conclude that ACXP’s ibezapolstat could offer previously unheard-of efficacy in the treatment of CDI. And, the judgement to move the trial forward early wasn’t made out of haste – the data simply deserves the rare accolade.
The early termination was based on evidence of ibezapolstat accomplishing the primary and secondary objectives of eradicating the infection (100%), preventing infection recurrence (100%), and having a manageable adverse event profile. Even better, aside from a different enrollment size, the 2b trial is expected to provide similarly exceptional results. An important detail for investors to note about the 2b trial is that it’s expected to be a quick one. Treatment cycles last roughly 40 days, and topline data will become available soon after. Furthermore, as this double-blind, randomized, active-controlled, non-inferiority, Phase 2b segment will be conducted at 12 U.S. clinical trial sites, the trial may reach its enrollment cap quicker than expected.
Should all continue going according to plan, the trial is expected to bring great news to ACXP, investors, and patients alike. The trial is designed to investigate the clinical efficacy of ibezapolstat in treating CDI, including pharmacokinetics and microbiome changes from baseline. It will further test for anti-recurrence microbiome properties seen in the Phase 2a trial, including the treatment-related changes in alpha diversity and bacterial abundance and effects on bile acid metabolism.
Most importantly, data from the trial will be put head-to-head with the current standard of care and front-line treatment, vancomycin. And, with the trial expected to be a speedy one, it’s critical that investors take notice of an apparent valuation disconnect before it has the chance to correct itself. If ibezapolstat outperforms vancomycin, as the 2a data suggests, physicians will be likely moved to use the antibiotic as soon as it is approved. Not only that, but a successful trial would likely bring massive returns those who have taken a position in ACXP at current levels.
With its Phase 2a trial demonstrating a 100% success rate, a feat previously unheard of in the sector – ibezapolstat is a strong bet.
Ibezapolstat and Vancomycin Head-to-Head: Phase 2b
The new trial is a double-blind, randomized 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for a recurrence of CDI. The two treatments will be identical in appearance, dosing times, and the number of capsules administered to maintain the blind.
As noted, the Phase 2b clinical trial endpoints include results evaluating pharmacokinetics (P.K.) and microbiome changes and will continue to test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. If the non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.
Here’s the main takeaway for investors. While the scientific language may be difficult to decipher, here’s what isn’t: ibezapolstat’s Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment, as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, both during and after therapy. And, that’s only the beginning.
ACXP’s latest data also shows an increased concentration of secondary bile acids during and following ibezapolstat therapy, which is known to correlate with colonization resistance against C. difficile. A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence compared to vancomycin.
This is a particularly notable feature, because while C. difficile can be a normal component of the healthy gut microbiome; when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid, and mucous secretion, as well as damage to the intestinal mucosa. Ibezapolstat inhibits and may even entirely shut down their survival.
Ibezapolstat temperament toward bile acids is also important. These bile acids perform many functional roles in the G.I. tract, with one of the most important being the maintenance of a healthy microbiome by inhibiting C. difficile growth.
Primary bile acids, secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, produced by the normal gut microbiota through the metabolism of primary bile acids, do not induce C. difficile sporulation and protect against recurrent disease.
One final detail noted by ACXP is that since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids is uninhibited, which may contribute to an anti-recurrence effect.
All things considered: ibezapolstat is demonstrating efficacy once thought to be unachievable, and investors still have the chance to take notice before the rest of the industry catches up.
Ibezapolstat Brings Relief to a Sector in Dire Need
Above all, ACXP’s findings may lead to an improved treatment for patients who desperately need it. According to a 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI is still a major medical issue prevalent in hospitals, long-term care facilities, and even the general public. In fact, according to an article published in the New England Journal of Medicine, C. difficile is one of the most common causes of health-care-associated infections in hospitals.
According to estimates, C. difficile causes around 500,000 infections and 20,000 fatalities in the United States each year. Additionally, ACXP places the recurrence rate of two of the three antibiotics currently used to treat CDI at between 20% and 40% among approximately 150,000 patients treated. They further state that the annual incidence of CDI in the United States is beginning to approach 600,000 infections, with a 9.3% fatality rate. Clearly, this is a significant medical issue that is not being adequately addressed by the current standard of care. Ibezapolstat may be the solution that finally brings relief to patients suffering from debilitating and recurring symptoms.
If this is the case, investors can anticipate a more suitable share price valuation to coincide with trial updates. After all, when comparing ACXP to peers conducting similar studies, a massive valuation disconnect becomes easily apparent.
Here's an example: despite having a much better efficacy and safety profile than Summit Therapeutics' (NASDAQ: SMMT) C. difficile treatment candidate, ACXP is currently trading at around a fifth of SMMT's market cap. Thus, one could argue that saying ibezapolstat is exposing an "undervalued opportunity" doesn’t just apply to ACXP; it's a shining example of a correct utilization of the term. Nonetheless, one of the best aspects of markets is that their flaws in valuing companies can create major opportunities for observant investors. In cases such as ACXP, the valuation disconnect is so obvious that it likely won’t take long for the market to correct its assessment. And, while ACXP’s Phase 2b trial is underway, investors still have time climb aboard before that happens.
2022 Could Be Transformative for ACXP
The bottom line is that ACXP could be less than 12 months from a major jump in valuation. Moreover, it's always nice to get some side-by-side comparison that can justify an almost 450% increase in market cap, in this case using SMMT as a comparable. A 450% surge may sound like a stretch, but at the price ACXP is currently trading at, knowing the performance of its flagship drug candidate, it would be more accurate to simply call it a fair valuation. Even in an unpredictable and volatile stock market, the market cap appreciation is likely to be significantly higher than ACXP’s current valuation if ACXP successfully completes Phase 2b.
In every available metric so far, ACXP's ibezapolstat has proven potential like nothing the sector has ever seen. It’s no exaggeration to state that should the treatment continue to post similar results throughout the rest of its clinical trials, ibezapolstat will essentially own the C. difficile treatment market following its approval. The market is begging for a more effective treatment option, and physicians would jump at the opportunity to have a better way of treating their patients.
As a result, the value proposition behind ACXP isn't just appealing; it's compelling. It’s also a timely proposition, given that topline results are due to be posted in around two quarters.
Another important consideration is that there is rarely an opportunity to invest in a biotech company with a potentially transformative clinical trial that’s only a month long in duration. Not only that, but few are headed into these trials with the unparalleled efficacy rates of ACXP’s earlier studies. Knowing this, as well as the fact that a Phase 3 company can often multiply a share price, an investment into ACXP is a consideration that should not be procrastinated.
Therefore, paying attention to the data will the best way to respond in the coming months. All signs are pointing to a near-term approval of ibezapolstat, and once that occurs, an opportunity similar to what is being presented today will be hard to come by any time soon.
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