The ID Pipeline: FDA Activity From the Week of August 18, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of August 18, 2019.

ATLAS-2M: Positive Top-Line Results for Long Acting Cabotegravir + Rilpivirine

On Thursday, August 22, 2019, Janssen and ViiV Healthcare announced positive top-line results from the phase 3 ATLAS-2M study of an investigational, long-acting, 2-drug injectable regimen of cabotegravir and rilpivirine.

ATLAS-2M is a phase 3 randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority study evaluating the antiviral activity and safety of the cabotegravir + rilpivirine administered every 8 weeks compared with every 4-week administration throughout a 48-week treatment period in 1045 adults living with HIV.

The regimen is being co-developed as a collaboration between the Janssen Pharmaceutical Companies of Johnson & Johnson and ViiV Healthcare.

According to a statement issued by Janssen, ATLAS-2M has achieved its primary objective, demonstrating that injections administered every 8 weeks is as effective as injections every 4 weeks in maintaining viral suppression in adults who are virally suppressed.

The full story is available here.

FDA Approves Lefamulin for Community-Acquired Bacterial Pneumonia

On Monday, August 19, 2019, the FDA approved lefamulin (Xenleta) for the treatment of community-acquired bacterial pneumonia (CABP) after results from 2 phase 3 studies showed the novel pleuromutilin antibiotic to be non-inferior to existing treatment options.

“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” said Ed Cox, MD, MPH, director of FDA’s Office of Antimicrobial Products in a statement issued by the FDA. “For managing this serious disease, it is important for physicians and patients to have treatment options. This approval reinforces our ongoing commitment to address treatment of infectious diseases by facilitating the development of new antibiotics.”

In total, the efficacy of lefamulin was evaluated in 1289 patients with CABP. In the LEAP 1 trial, IV to oral lefamulin was found to be non-inferior to IV to oral moxifloxacin with or without linezolid. In LEAP 2, lefamulin again successfully met the FDA primary endpoint of non-inferiority compared with moxifloxacin for early clinical response, which was evaluated in the intent-to-treat patient population 72 to 120 hours after treatment was initiated.

The full story is available here.

Moderna Inc. Granted Fast Track Designation for Investigational Zika Vaccine

On Monday, August 19, 2019, the FDA granted Fast Track Designation to Moderna, Inc. for its investigational Zika vaccine (mRNA-1893) currently being evaluated in a Phase 1 study for the prevention of Zika virus infection in healthy adults.

mRNA-1893 is designed to mimic the cell's natural response to infection and induce the secretion of virus-like particles. A current Phase 1 randomized, observer-blind, placebo-controlled, dose-ranging study is evaluating the candidate for safety, tolerability, and immunogenicity in healthy flavivirus seropositive and seronegative adults ages 18 to 49 years.

“Protecting against Zika virus transmission, particularly in women during pregnancy, continues to be an area of high unmet need. Fast Track designation supports our belief in the clinical potential of mRNA-1893 and the importance of developing an effective vaccine that can be rapidly developed and deployed,” Tal Zaks, MD, PhD, chief medical officer at Moderna, said in a press release. “Our Zika program is part of Moderna’s broader commitment to improving global public health through developing mRNA vaccines to prevent the spread of infectious diseases.”

The full press release is available here.