(1) Acurx Pharmaceuticals LLC is promulgating the first new class of antibiotics in 30 years: DNA polymerase IIIc inhibitors. Long a target of the pharma industry, prior inhibitors of this key Gram-positive replication enzyme were beset with host toxicity issues. Acurx's lead agent ibezapolstat has cleared phase 1 and is well into phase 2a without such safety issues. The company outright owns the intellectual property on which its agents are based and is not merely a licensee. Acurx purchased the technology from GLSynthesis, Inc., in February 2008. At that time, that firm was owned and controlled by two retired professors from University of Massachusetts.
(2) Lead agent ibezapolstat has QIDP (qualified infectious disease product) designation and FDA Fast-Track Designation and is eligible for coverage under the DISARM act. As a new chemical entity, ibezapolstat, also having fetched QIDP status, will have 10 years of commercial exclusivity upon winning FDA marketing approval. Second agent ACX-375C, still preclinical, will have similar designations sought. Ibezapolstat has patent protection through 2039. ACX-375C, chemically related to ibezapolstat, is nearing IND (investigational new drug).
(3) Ibezapolstat has rapidly cured the first 6 of 6 enrolled patients in a phase 2a study of Clostridoides difficile enterocolitis. Taken orally, intraluminal levels of antibiotic are high because the agent is not absorbed. With metronidazole no longer recommended to treat C. diff., problems with dysbiosis and excessive normal flora elimination by oral vancomycin, and prohibitive costs associated with fidaxomicin, ibezapolstat is poised to become first-line treatment for C. diff. Fidaxomicin is not covered by the DISARM act, but ibezapolstat will be.
Although the phase 2a trial is single-arm, time to symptom abatement appears to be MORE rapid than with oral vancomycin therapy. Indeed, at this writing Acurx plans to pursue a label indication of merely 5-7 days of therapy if ongoing data continues supporting this dosing regimen. Phase 2b will compare ibezapolstat to vancomycin, and NDA (new drug application) will be based on non-inferiority to vancomycin.
(4) ACX-375C will compete with daptomycin and linezolid for coverage of resistant Staph. aureus, against which ample activity is evident. It has highly potent in vitro against vancomycin-resistant Enterococcus (VRE). At present, linezolid is the sole drug FDA approved for VRE. Like ACX-375C it is available in IV and oral forms, but loses market exclusivity in 2021. Daptomycin, available only in IV form, is now off patent. ACX-375C's patent duration is anticipated to be similar to that of ibezapolstat.
(5) Fact: if you're an adult in North America, your likeliest reason for hospitalization is because of the unchecked menace of antimicrobial resistance. In the Covid-19 era with its heavy customary use of antibiotics, the once levelled-off profusion in C. diff. prevalence may resume its rise. The CDC continue to deem C. diff. as an urgent threat incurring an urgent need for new antibiotics to treat it.
(6) In addition to aggressively invoking all new incentives and inducements for antibiotics developers, Acurx is in a highly competitive position as regards procurement of non-dilutive grant funding and private sector funding for its objectives and actively seeks such funding.
(7) Case study: In December 2014, Merck ($MRK) paid US$9.5 billion for Cubist ($CBST) largely to obtain marketing access to agents daptomycin and fidaxomicin. Acurx finds itself in an eerily analogous situation, with an agent for MRSA and VRE, as well as another for C. diff. With its lead agent about to advance to phase 2b, perhaps US$100 million is a fair pre-market valuation for Acurx, which tentatively plans IPO in mid-2021. Success with both agents could thus poise pre-market Acurx investors for plausible gains of perhaps 250-500 percent; Acurx shares will see some dilution as the company continues to raise capital, but value creation for now is grossly outstripping potential dilutive losses.
(8) Acurx was founded and is helmed by industry veterans Bob DeLuccia, MBA, who led U.S. Sanofi operations for decades, and David Luci, CPA, JD. Both have impressive high-profile leadership resumes with multiple biotech firms of consequence (https://www.acurxpharma.com/about/management-team).
(9) The company is directly selling shares to investors through 30 September 2020 at $3.25, with $10,000 minimum investment. Non-accredited investors are welcome to participate in the funding round. Investor eligibility is independent of citizenship and domicile.
Institutional interest and interest from industry insiders in the firm's fundraising has been considerable, but we aren't naming names.
(10) Acurx was first identified by and has received highly favorable coverage from biotech small-cap and special situations analysis website BioPub.co, which has designated Acurx one of its top 12 most appealing investment opportunities.Acurx investor relations are provided by San Diego Torrey Hills Capital, known for selectivity and curation in backing early stage biotech firms. Further information about Acurx and the capital raise is available from BioPub.co (write to [email protected]), Torrey Hills Capital or the company directly.
Dr. KSS is the founder and editor-in-chief of BioPub.co. He is an MD with an additional PhD in biochemistry, and for the past 20 years, in addition to practicing, being a researcher, and conducting clinical trials, he has been investing in biotech companies with great success. Dr. KSS earned his degrees at a top 10 U.S. institution, where he was an NIH scholar and graduated with top honors. He has extensive post-doctoral research experience and am board certified in internal medicine and also gastroenterology. His goal is to discuss companies and use discussions of their technology, their drugs or planned drugs, as ways of teaching about physiology and disease states, along with their issues and opportunities.
Disclosure: The author has a long position in Acurx from participation in series A, series B and crossover funding rounds. The above is neither a recommendation nor a solicitation to purchase shares. BioPub has never been compensated by a company for covering it and declines such compensation. Because of illiquidity and potential for loss of all invested capital, pre-market investing entails exceptional risk. Prospective investors are encouraged to discuss investing here with a personal financial advisor prior to acting.[NLINSERT]
1) Dr. KSS: disclosures are listed above. I determined which companies would be included in this article based on my research and understanding of the sector.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.