TAXIS Pharmaceuticals has received an FDA QIDP designation for TXA14007, its investigational efflux pump inhibitor (EPI) in combination with levofloxacin for the treatment of hospital-acquired pneumonia (HAP) and ventilator associated pneumonia (VAP).
MIAMI, July 15, 2025 /PRNewswire-PRWeb/ -- TAXIS Pharmaceuticals, a clinical stage company at the forefront of developing therapies to treat multidrug-resistant bacterial infections and combat antimicrobial resistance (AMR), announced today that it has received an FDA Qualified Infectious Disease Product (QIDP) designation for TXA14007, its investigational efflux pump inhibitor (EPI) in combination with levofloxacin for the treatment of hospital-acquired pneumonia (HAP) and ventilator associated pneumonia (VAP). This designation acknowledges the significant potential of TAXIS Pharmaceuticals' novel, investigational EPIs to enhance the efficacy of existing antibiotics, which could provide a powerful new defense against multidrug-resistant bacterial infections.
TAXIS' investigational EPIs are drugs designed to combat gram-negative multidrug-resistant (MDR) pathogens, and while EPIs have long been explored in anti-cancer indications, no EPIs have ever been approved in the antibiotic space. By blocking the mechanisms that bacterial cells use to expel antibiotics, EPIs can revitalize the efficacy of antibiotics, many of which have lost effectiveness or now require significantly higher doses to provide any therapeutic benefit.
TAXIS' TXA14007 class of EPIs significantly enhanced the effectiveness of levofloxacin and other antibiotics against a wide range of drug-resistant P. aeruginosa strains found in clinical settings. Preclinical data on TXA14007 shows no signs of inherent toxicity and finds that it is effective in improving the action of levofloxacin in animal efficacy models.
The benefits of QIDP designation are substantial: this will enable TAXIS to access the FDA's Fast Track program, allow for Priority Review, and make the compound eligible for a potential five-year extension of market exclusivity upon approval. These advantages are designed to accelerate the development and review processes, ensuring that novel therapies can reach patients faster and address urgent public health needs efficiently. With the support of this designation, TAXIS Pharmaceuticals is poised to advance the development process for its EPIs.
"The QIDP designation is a critical milestone in our mission to deliver effective solutions against antimicrobial resistance," says Gregory G. Mario, MBA, President and CEO of TAXIS Pharmaceuticals. "Too many people are dying from infections like Hospital Acquired Pneumonia – infections that should be treatable. We are committed to our mission because we know that lives are on the line."
This news marks TAXIS Pharmaceuticals' second FDA QIDP designation; the first was granted for TXA709, the company's first investigational FtsZ inhibitor candidate, aimed at treating antibiotic-resistant methicillin-resistant staphylococcus aureus (MRSA). TAXIS Pharmaceuticals is seeking additional funding and partnerships with drug manufacturers to continue the development and commercialization of its investigational EPIs and its broader portfolio of investigational therapies aimed at addressing the escalating burden of antimicrobial resistance.
About TAXIS Pharmaceuticals
TAXIS Pharmaceuticals is a clinical-stage company developing new classes of anti-resistance therapies to treat life-threatening, multidrug-resistant bacterial infections. Our investigational drug candidates – including efflux pump inhibitors, dihydrofolate reductase inhibitors, and FtsZ inhibitors – aim to combat antimicrobial resistance (AMR). TAXIS' investigational therapies currently target several different bacterial pathogens, many of which are on the WHO Priority Pathogen List. Our mission is to reduce and potentially eliminate the threat of current and emergent antimicrobial resistant bacteria across a wide range of infectious diseases and save lives. To learn more, visit: https://taxispharma.com/.
Forward-Looking Statements
Investors and stakeholders should be aware that this press release contains forward-looking statements and information. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as "may", "might", "will", "should", "could", "expect", "plan", "anticipate", "believe", "estimate", "project", "intend", "future", "potential" or "continue", and other similar expressions are intended to identify forward looking statements.
For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking.
All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that we expected. Any forward-looking statement speaks only as of the date on which it was made.
We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. This press release is not, and nothing in it should be construed as, an offer, invitation or recommendation in respect of our securities, or an offer, invitation or recommendation to sell, or a solicitation of an offer to buy, any of our securities in any jurisdiction. Neither this press release nor anything in it shall form the basis of any contract or commitment. This press release is not intended to be relied upon as advice to investors or potential investors and does not take into account the investment objectives, financial situation or needs of any investor.
Media Contact
Jennifer Ringler, TAXIS Pharmaceuticals, 1 973-647-5004, [email protected], https://taxispharma.com/
SOURCE TAXIS Pharmaceuticals
Share this article