The ID Pipeline: FDA Activity From the Week of July 28, 2019

August 3, 2019

Here is a look at infectious disease-related US Food and Drug Administration news from the week of July 28, 2019.

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of July 28, 2019.

LexaGene Receives FDA, CDC Approval to Test Samples for Superbugs

On Tuesday, July 30, 2019, the FDA and US Centers for Disease Control and Prevention (CDC)'s Antibiotic Resistance (AR) Isolate Bank recognized LexaGene Holdings, Inc. as an institution approved to receive samples for AR testing.

The approval gives LexaGene access to a huge repository of fully characterized pathogens to test for antibiotic resistance and advance its diagnostic tools.

“LexaGene now has a formal relationship with the CDC and FDA, 2 agencies that view antimicrobial resistance to be the biggest health threat of our time," Jack Regan, PhD, BS, LexaGene’s CEO and founder, said in a press release. "We will leverage this relationship to improve the performance of our technology. Antibiotic resistant pathogens are predicted to kill 10 million people by 20501. To avoid this dreadful prediction, we need better diagnostics to improve our antibiotic stewardship and to lower the potential for contagion transmission.”

Read the full press release here.

Positive Topline Results From Phase 2 STRIVE Trial of Cidara's Rezafungin

On Monday, July 29, 2019, Cidara Therapeutics, Inc. announced positive topline results for Part B of the global phase 2 STRIVE trial evaluating rezafungin.

Rezafungin, the company's novel echinocandin antifungal, met all of the objectives for safety, effiacacy, and tolerability in patients with candidemia and/or invasive candidiasis.

“We extend our sincere thanks to the STRIVE participants, investigators and their site staff for their dedication to this trial. Rezafungin has the potential to be the first safe and effective once-weekly, first-line treatment option for patients with difficult-to-treat and deadly invasive Candida infections, and we believe this trial moves us one step closer to market,” Jeffrey Stein, PhD, president and chief executive officer of Cidara, said in a press release. “Additionally, the combined STRIVE A and B results are aligned with our expectations for the ongoing ReSTORE Phase 3 trial, from which the data, if positive, will be used to support our NDA.”

Cidara reported positive topline results from Part A of the STRIVE trial in March 2018. The objective of STRIVE B was to show comparability in efficacy and safety of rezafungin dosed once-weekly versus caspofungin dosed once-daily.

Read the full press release here.

In Effort to Streamline Lyme Diagnosis, FDA Clears New Indications for 4 Existing Tests

On Monday, July 29, 2019, the FDA cleared new indications for 4 existing Lyme disease tests to aid in diagnosis and streamline a new testing paradigm.

Currently, testing for Lyme involves a 2-step process with an enzyme immunoassay followed by a Western Blot protein test. The new testing paradigm would simplify the process into 2 enzyme immunoassays run concurrently or sequentially.

“Lyme disease can have a devastating impact on patients. With today’s action, clinicians have a new option to test for Lyme that is easier to interpret by a clinical laboratory due to the streamlined method of conducting the test. These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a press release.

The FDA has now cleared the following tests for marketing: ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgM Test System, and the ZEUS ELISA Borrelia burgdorferi IgG Test System.

Read the full press release here.