There's good news, and then there's excellent news. The good news is that Acurx Pharmaceuticals (NASDAQ: ACXP) is nearing its Phase 3 trial to get a best-in-class front-line treatment for C. difficile to the market. The excellent news is that millions of patients could potentially be cured of this debilitating condition with vastly reduced recurrent infection saving billions in downstream costs to the healthcare system.
Coverage of ACXP's ibezapolstat candidate so far has been nothing short of optimistic, with references as the candidate becoming the "gold standard" or “front line treatment” to treat C. diff now a common phrase. And with another data release expected in Q2, further support of that presumption could be in the crosshairs.
There are plenty of precedents to suggest the news will be good.
Phase 2a Data Is Compelling
Data from its Phase 2a clinical trials show that ibezapolstat could cure C. diff infections in patients with primary C. diff or recurrent C. diff and, at the same time, prevent a recurrence. No other treatment has come close to matching those results. Nor has any matched this:
In its completed Phase 2a study of its ibezapolstat candidate, all ten patients enrolled were clinically cured of infection within two days of the end of treatment with no recurrence of C. diff at the 28-day follow-up visit. That's not all.
The data was so good in showing positive clinical and safety results, along with beneficial effects on the gut microbiome, that they resulted in the SABrecommending early termination of the study and provided the first clinical indication of ibezapolstat's potential superiority over Vancomycin based on historical data. Acurx took advantage of that opportunity by jumping directly to its Phase 2b study.
That means patients could be closer to receiving potentially curative treatment for a debilitating bacterial infection. Furthermore, ACXP's ibezapolstat targets both presentations of C. diff, primary and recurrent infection. Primary C. diff is defined as the first episode of C. diff, while recurrent C. diff refers to the second or additional episodes following the primary infection. Re-infection occurs in up to 35% of individuals, with the risk of recurrence increasing with each episode, and the primary cause of C. diff mortality and the principal contributor of C. diff's more than two billion dollars in annual cost to the U.S. healthcare system contributed from patients with recurrent infection.
But if ACXP gets its way, that burden could be mitigated. They are advancing a 64-patient Phase 2b study, with enrollment continuing across centers across the country. The study intends to confirm preliminary data and further assess the efficacy and safety of ibezapolstat and its effects on the gut microbiome compared to Vancomycin. Endpoints include evaluating the comparative effects of ibezapolstat on clinical cure and sustained clinical cure (defined as clinical cure at the end of treatment visit and no recurrence within 28 days). The most excellent news is- study enrollment is expected to complete in mid 2023, with the release of interim results planned for mid 2023.
Timely To The C. diff Treatment Opportunity
The market opportunity is significant, with C. diff affecting individuals of any age and associated with significant and debilitating symptoms and mortality. Worse, there has been a rapid increase in the incidence of community-acquired infection over the past few decades, wreaking a substantial economic impact on the healthcare system and patients due to recurrences, hospitalization, prolonged length of stay, and the cost of treatment are estimated at roughly $2.8 billion in the U.S. annually. That's just the direct costs. Further impact results from indirect societal costs, including loss of paid employment and family disruptions.
And for the past six decades, Vancomycin has been the front-line antibiotic for treating C. diff and many other life-threatening infections. Still, while it's been an effective go-to therapy for C. diff that faced very little competition for decades, the time for change has come. That's inherent to Vancomycin's growing weakness, especially in preventing re-infection, which has left a trail of severe illness and a death rate of about 20,000 annually in the U.S. alone.
Remember, clinical data collected over the years indicates that a typical new antibiotic has a peak efficacy of about five years. After that, the process of antimicrobial resistance begins, resulting in bacteria learning to identify an antibiotic as a medicine and then finding a way to morph their properties to avoid being killed. In turn, most antibiotics become less and less effective over time. That's shown in cases of C. diff, with today's approved therapies allowing an estimated recurrence rate of roughly 20% after the initial treatment and increasing to 60% after multiple recurrences.
Thus, there is an open-door opportunity for ACXP and ibezapolstat.
Ibezapolstat Is Different, And That's Good
And ACXP is hoping to take advantage by demonstrating advantages, particularly those related to the gut microbiome that lives inside the digestive tract. These microbes play a vital role in health by helping to break down food, absorb nutrients, and to protect against disease-causing microorganisms. Research has emphasized that changes in the composition and diversity of gut microbiomes can dramatically affect physical and mental well-being raising a high risk of recurrent C diff as well as a high risk of other diseases like cancer and diabetes.Acurx's candidate is affecting these bacteria the right way by killing the C diff bacteria in a narrow spectrum sense leaving healthy bacteria alone.
Its published Phase 1 study of Ibezapolstat in 10 healthy volunteers showed that Acrux's C. diff treatment candidate was effective against C. diff and, while it influenced changes in the structure and behavior of disease-causing bacteria, it did not affect the healthy disease-fighting bacteria. Those results suggest that ibezapolstat is associated with a lower risk of C. diff recurrence than Vancomycin. That's not all.
Ibezapolstat did not adversely affect the gut microbiome, unlike Vancomycin, which had undesirable effects on the gut microbiome and was ineffective against drug-resistant bacteria. Combined data, therefore, suggest that ibezapolstat is positioning to become a first-line treatment for C. diff infection, a result of its potential to affect a total reduction treatment failures and in recurrence rates. If it does earn that position, it could be the most meaningful contribution to improving morbidity and mortality in decades and simultaneously help save billions in healthcare and societal costs each year.
Winning The Race To Market
Know this, too. Acurx Pharmaceuticals appears to be distancing itself from potential competitors. To date, Pfizer's (NYSE: PFE) vaccine candidate PF-06425090, and the antibiotics cadazolid investigated by Johnson & Johnson (NYSE: JNJ) and surotomycin, investigated by Merck & Co (NYSE: MRK), failed to meet their primary endpoints. They are not the only ones falling short of expectations.
Last year, Summit Therapeutics (NASDAQ: SMMT) decided to table the development of ridinilazole for pediatric C. diff. And in January of this year, Finch Therapeutics Group (NASDAQ: FNCH) halted its development of a fecal transplant technology for recurrent C. diff after failing to meet its intended objectives.
Thus, the competitive landscape could be at its thinnest level ever. But it's not just the competitive distance Acurx Pharmaceuticals is accruing that makes them an attractive consideration. The biggest reason is that they are demonstrating, with compelling evidence and data, that they are on the verge of getting an effective and best-in-class C. diff treatment to patients. If so, in addition to potentially saving millions of lives, billions could be earned. That's a win-win proposition too good to ignore.
And based on the fact that Acurx stock is showing strength in weak markets, many are doing more than paying attention; they are also taking advantage of a valuation disconnect that may close quickly. In fact, with a trial update expected next quarter, the gap between share price and near-term opportunity could close much sooner than later, and if data posts as expected, deservedly so.
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