Phase 3 Trial Data on Pneumonia Drug Telavancin Presented by Theravance Biopharma

Phase 3 Trial Data on Pneumonia Drug Telavancin Presented by Theravance Biopharma

Ireland-based Theravance Biopharma presented new data on Vibativ (telavancin) for the treatment of pneumonia at the American Thoracic Society’s International Conference May 13-18 in in San Francisco.

The poster-presentation data, titled “Clinical Efficacy and Safety of Telavancin in Hospital-Acquired and Ventilator-Associated Pneumonia (HAP/VAP) Patients with Monomicrobial S. aureus Infection,” was presented during the session Clinical Aspects of CAP, HCAP, HAP, and VAP.

Vibativ is a bactericidal, once-a-day, injectable lipoglycopeptide antibiotic with well-documented in vitro potency, and a dual mechanism of action engineered to inhibit bacterial cell wall synthesis and disrupt bacterial cell membrane function.

The drug is currently FDA-approved for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by susceptible isolates of Staphylococcus aureus when there are no adequate alternative treatments.

Vibativ is also approved for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) triggered by susceptible isolates of Gram-positive bacteria, including methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA) strains.

Findings reinforced studies that indicated Vibativ may serve as an appropriate treatment for specific HABP/VABP patient populations with MRSA.

Researchers presented results from a post hoc analysis of the previously completed Phase 3 Assessment of Televancin for Treatment of Hospital-Acquired Pneumonia (ATTAIN1 and ATTAIN2) studies, which supported the regulatory approval of televancin for the treatment of HABP/VABP.

The post hoc analysis was led by researchers at Weill Cornell Medical Center & Medical College and Baystate Medical Center in collaboration with Theravance. The goal was to further assess and compare the ATTAIN studies’ clinical cure rates and safety scores for telavancin vs. vancomycin (also an antibiotic) across a range of comorbidities.

Findings reinforced studies that indicated Vibativ may serve as an appropriate treatment for specific HABP/VABP patient populations, including those with MRSA.

According to a press release, Vibativ was discovered in a research program focused on finding new antibiotics for serious S. aureus infections and other Gram-positive bacteria, including MRSA and MSSA strains.

The drug has proven to be effective against difficult-to-treat Gram-positive infections in several large, multinational registration studies, involving one of the largest cohorts of patients with S. aureus infections ever studied. There is also extensive evidence of the drug’s in vitro potency and in vivo activity against a wide collection of Gram-positive bacterial pathogens, including difficult-to-treat and multidrug-resistant variants.

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