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ABSSSI Study Overview

BAXDELA® (delafloxacin) ABSSSI Clinical Trials

Phase 3 Noninferiority Trials Design Evaluated in 2 randomized, double-blind, multicenter trials of 1510 patients

Assessment at Baseline: Lesion size ≥75 cm2

TRIAL 1: IV Only BAXDELA IV
(n=331)

TRIAL 2: IV to Oral BAXDELA IV to oral
(n=423)

BAXDELA 300 mg IV q12h

BAXDELA 300 mg IV q12h for 6 doses, then switched to 450 mg oral q12h

vancomycin plus aztreonam
(n=329)

vancomycin
15 mg/kg plus aztreonama

vancomycin plus aztreonam
(n=427)

vancomycin
15 mg/kg plus aztreonama

PRIMARY Endpoint: At least 20% reduction in lesion size at 48-72 hours

SECONDARY Endpoint: At day 14 (+/- 1) follow-up, investigator-assessed clinical success defined as complete or near-complete resolution of signs and symptoms with no further antibacterial therapy needed

aVancomycin 15 mg/kg q12h was recommended. Monitoring was done on days 2 and 6 with target trough concentration of 15-20 µg/mL.

Baseline Characteristics: Pooled Data, Phase 3 Clinical Trials

Patient Population1510 patients across 2 trials

Patient population infographic for BAXDELA trial - males
62% Male
Patient population infographic for BAXDELA trial - females
38% Female
Average Age
Patient population infographic for BAXDELA trial - ages

Relevant Comorbidities

Patient comorbidities bar chart for BAXDELA trial

Baseline Infection Type1

Baseline infection chart for BAXDELA trial

Systemic Signs of Infection1

Systemic infections graph for BAXDELA trial

aOut of all patients randomly assigned to treatment, only 1 did not meet the requirement for having at least 2 systemic signs of infection.

Lesion Size1

In Phase 3 trials, there was a wide range in the measurements of surface area of erythema at baseline assessments.

  • All patients evaluated had lesions equal to or greater than 75 cm2
  • Overall mean (SD) surface area of erythema, measured by digital planimetry, was 321.1 cm2 (311.570)

SD = standard deviation.
1. Data on file. Melinta Therapeutics, LLC.

BAXDELA Monotherapy Demonstrated Efficacy

Primary Endpoint in Phase 3 Trials

Objective clinical response at 48-72 hoursa in the ITT population

At least 20% reduction in lesion size.a

TREATMENT DIFFERENCE (2 sided, 95% CI)
TRIAL 1:
−2.6 (−8.8, 3.6)
TRIAL 2:
3.1 (−2.0, 8.3)

BAXDELA 300 mg IV q12h vs comparator

BAXDELA 300 mg Vancomycin 15 mg/kg + aztreonam
BAXDELA IV primary endpoint chart

BAXDELA 300 mg IV q12h for 6 doses, then a mandatory switch to oral BAXDELA 450 mg q12h vs comparator

BAXDELA 300 mg, then 450 mg oral Vancomycin 15 mg/kg + aztreonam
BAXDELA IV-to-oral primary endpoint chart

aDetermined by digital planimetry of the leading edge of erythema without other reasons for failure (use of another antibiotic or surgical procedure to treat for lack of efficacy). Missing patients were treated as failures in the ITT analysis set.
CI = confidence interval; ITT = intention-to-treat.

Secondary Endpoint in Phase 3 Trials

Investigator assessment of response at Follow-Up Visit (day 14 +/− 1) in the CE population

Success was defined as cure + improved where patients had complete or near-complete resolution of signs and symptoms, with no further antibiotic therapy needed.

TREATMENT DIFFERENCE (2 sided, 95% CI)
TRIAL 1:
−0.9 (−4.3, 2.4)
TRIAL 2:
−0.9 (−3.9, 2.0)

BAXDELA 300 mg IV q12h vs comparator

BAXDELA 300 mg IV Vancomycin 15 mg/kg + aztreonam
BAXDELA IV treatment difference chart

BAXDELA 300 mg IV q12h for 6 doses, then a mandatory switch to oral BAXDELA 450 mg q12h vs comparator

BAXDELA 300 mg IV, then 450 mg oral Vancomycin 15 mg/kg + aztreonam
BAXDELA IV-to-oral treatment difference chart

CI = confidence interval; CE = clinically evaluable consisted of all ITT patients who had a diagnosis of ABSSSI, received at least 80% of expected doses of the study drug, did not have any protocol deviations that would affect the assessment of efficacy, and had investigator assessment at the Follow-Up Visit.

BAXDELA Monotherapy Effective Against MRSA1

In the microbiological ITT (MITT) population, primary and secondary endpoint results for MRSA patients were as follows:

  • Clinical Response at 48-72 hours: BAXDELA, 125/144 (86.8%); comparator, 121/141 (85.8%)
  • Investigator-Assessed Success at Follow-Up: BAXDELA, 122/144 (84.7%); comparator, 116/141 (82.3%)

BAXDELA MONOTHERAPY ERADICATION* OF MRSA INFECTION

  • MRSA eradication was a prespecified exploratory analysis in BAXDELA Phase 3 clinical trials
  • Analysis set consisted of patients who were Microbiologically Evaluable at Follow-Up visit for Investigator-assessed response (MEFUI) who had a baseline pathogen identified known to cause ABSSSI

POOLED DATA TRIALS 1 AND 2

BAXDELA 300 mg IV (Trial 1); BAXDELA 300 mg IV, then 450 mg oral (Trial 2) Vancomycin 15 mg/kg + aztreonam
BAXDELA treatment response chart of patients with MRSA

1. Data on file. Melinta Therapeutics, LLC.

*Microbiological response for all groups was defined as eradicated or persisted. Each group included both documented and presumed results.

  • Documented: Baseline pathogen was or was not present in cultures of the original site of infection at follow-up visit
  • Presumed: Baseline pathogen present, but no material available for culture/no culture done at follow-up visit; investigator-assessed response

Broad Coverage: Gram-positive Pathogens, Including MRSA, and Gram-negative Pathogens, Including Pseudomonas aeruginosa

Outcomes By Baseline Pathogen Pooled data from Phase 3 trials

Analysis set: MITT consisted of all randomized patients who had a baseline pathogen identified that is known to cause ABSSSI

Gram-Positive Pathogens

BAXDELA Vancomycin + aztreonam

CLINICAL RESPONSE AT 48-72ha

% OF PATIENTS (n/N)

BAXDELA gram-positive pathogen Staphylococcus aureus clinical response chart BAXDELA gram-positive pathogen MSSA clinical response chart BAXDELA gram-positive pathogen MRSA clinical response chart BAXDELA gram-positive pathogen Staphylococcus haemolyticus clinical response chart BAXDELA gram-positive pathogen Staphylococcus lugdunensis clinical response chart BAXDELA gram-positive pathogen Enterococcus faecalis clinical response chart BAXDELA gram-positive pathogen Staphylococcus agalactiae clinical response chart BAXDELA gram-positive pathogen Staphylococcus anginosus group clinical response chart BAXDELA gram-positive pathogen Staphylococcus pyogenes clinical response chart

aObjective clinical response was defined as a 20% or greater decrease in lesion size as determined by digital planimetry of the leading edge of erythema at 48 to 72 hours after initiation of treatment.
bDiscrepancy in the total numbers is due to multiple subjects having both MRSA and MSSA isolates.
MRSA = methicillin-resistant S aureus; MSSA = methicillin-susceptible S aureus.

INVESTIGATOR-ASSESSED SUCCESS AT DAY 14 (+/- 1)a

% OF PATIENTS (n/N)

BAXDELA gram-positive pathogen Staphylococcus aureus investigator-assessed success chart BAXDELA gram-positive pathogen MSSA investigator-assessed success chart BAXDELA gram-positive pathogen MRSA investigator-assessed success chart BAXDELA gram-positive pathogen Staphylococcus haemolyticus investigator-assessed success chart BAXDELA gram-positive pathogen Staphylococcus lugdunensis investigator-assessed success chart BAXDELA gram-positive pathogen Enterococcus faecalis investigator-assessed success chart BAXDELA gram-positive pathogen Staphylococcus agalactiae investigator-assessed success chart BAXDELA gram-positive pathogen Staphylococcus anginosus group investigator-assessed success chart BAXDELA gram-positive pathogen Staphylococcus pyogenes investigator-assessed success chart

aSuccess was defined as complete or near-complete resolution of signs and symptoms with no further antibacterial therapy needed at follow-up visit (day 14 +/- 1).
bDiscrepancy in the total numbers is due to multiple subjects having both MRSA and MSSA isolates.

Gram-Negative Pathogens

BAXDELA Vancomycin + aztreonam

CLINICAL RESPONSE AT 48-72ha

% OF PATIENTS (n/N)

BAXDELA gram-negative pathogen Escherichia coli clincal response chart BAXDELA gram-negative pathogen Enterobacter cloacae clinical response chart BAXDELA gram-negative pathogen Klebsiella pneumoniae clinical response chart BAXDELA gram-negative pathogen Pseudomonas aeruginosa clinical response chart

aObjective clinical response was defined as a 20% or greater decrease in lesion size as determined by digital planimetry of the leading edge of erythema at 48 to 72 hours after initiation of treatment.

INVESTIGATOR-ASSESSED SUCCESS AT DAY 14 (+/- 1)a

% OF PATIENTS (n/N)

BAXDELA gram-negative pathogen Escherichia coli investigator-assessed success chart BAXDELA gram-negative pathogen Enterobacter cloacae investigator-assessed success chart BAXDELA gram-negative pathogen Klebsiella pneumoniae investigator-assessed success chart BAXDELA gram-negative pathogen Pseudomonas aeruginosa investigator-assessed success chart

aSuccess was defined as complete or near-complete resolution of signs and symptoms with no further antibacterial therapy needed at follow-up visit (day 14 +/- 1).

Next: ABSSSI Safety & Tolerability

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, and EXACERBATION OF MYASTHENIA GRAVIS

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including:

  • Tendinitis and tendon rupture
  • Peripheral neuropathy
  • Central nervous system effects

Discontinue BAXDELA immediately and avoid the use of fluoroquinolones, including BAXDELA, in patients who experience any of these serious adverse reactions.

Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid BAXDELA in patients with known history of myasthenia gravis.

Contraindications

BAXDELA is contraindicated in patients with known hypersensitivity to delafloxacin or any of the fluoroquinolone class of antibacterial drugs, or any of the components of BAXDELA.

Warnings and Precautions

If any of the following reactions occur in patients receiving BAXDELA, discontinue treatment immediately and institute appropriate clinical measures. Avoid using BAXDELA in patients with a known history of any of these conditions. These reactions may occur after the first dose or with subsequent doses.

Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy and Central Nervous System Effects:

  • Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions from different body system.
  • Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion).

Tendinitis and Tendon Rupture:

  • Fluoroquinolones have been associated with an increased risk of tendinitis and tendon rupture in all ages. Tendinitis or tendon rupture can occur, within hours or days of starting a fluoroquinolone, or as long as several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally.
  • This risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over age 60 years of age, in patients taking corticosteroid drugs, and, in patients with kidney, heart, and lung transplant. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.
  • Discontinue BAXDELA immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon.

Peripheral Neuropathy:

  • Fluoroquinolones have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported in patients receiving fluoroquinolones, including BAXDELA. Symptoms may be irreversible in some patients.
  • Discontinue BAXDELA immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation and/or motor strength in order to minimize the development of an irreversible condition.

Central Nervous System Effects:

  • Psychiatric Adverse Reactions: Fluoroquinolones, including BAXDELA, have been associated with an increased risk of psychiatric adverse reactions.
  • Central Nervous System Adverse Reactions: Fluoroquinolones have been associated with an increased risk of seizures, increased intracranial pressure, dizziness, and tremors.

Exacerbation of Myasthenia Gravis:

  • Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Post-marketing serious adverse reactions, including death and requirement for ventilator support, have been associated with fluoroquinolone use in persons with myasthenia gravis.

Hypersensitivity Reactions:

  • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Hypersensitivity reactions have been reported in patients receiving BAXDELA.

Clostridium difficile-Associated Diarrhea:

  • Clostridium difficile-associated diarrhea (CDAD) has been reported in users of nearly all systemic antibacterial drugs, including BAXDELA, with severity ranging from mild diarrhea to fatal colitis.
  • C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antibacterial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use.
  • If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile should be discontinued, if possible. Appropriate measures such as fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Risk of Aortic Aneurysm and Dissection:

  • Epidemiologic studies report an increased risk of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve BAXDELA for use only when there are no alternative antibacterial treatments available.

Development of Drug-Resistant Bacteria:

  • Prescribing BAXDELA in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Blood Glucose Disturbances:

  • Fluoroquinolones have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death have been reported with other fluoroquinolones.

Adverse Reactions

The most common adverse reactions (≥2%) in patients treated with BAXDELA were nausea, diarrhea, headache, transaminase elevations, and vomiting.

INDICATIONS AND USAGE:

Acute Bacterial Skin and Skin Structure Infections (ABSSSI): BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections.

Community-Acquired Bacterial Pneumonia (CABP): BAXDELA is indicated in adults for the treatment of community-acquired bacterial pneumonia.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BAXDELA and other antibacterial drugs, BAXDELA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

Please see full Prescribing Information, including Boxed Warning, and the Patient Medication Guide.

You are encouraged to report side effects and product complaints associated with BAXDELA by calling 1-844-633-6568.

BAXDELA® is a registered trademark of Melinta Therapeutics, LLC, generally known as CorMedix Therapeutics.
© 2026 Melinta Therapeutics, LLC. All rights reserved. PP-BAX-US-0399 (v11.0) 03/2026

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, and EXACERBATION OF MYASTHENIA GRAVIS

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including:

INDICATIONS AND USAGE:

Acute Bacterial Skin and Skin Structure Infections (ABSSSI): BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections.

Community-Acquired Bacterial Pneumonia (CABP): BAXDELA is indicated in adults for the treatment of community-acquired bacterial pneumonia.