The ID Pipeline: FDA Activity from the Week of March 24, 2019

Here is a look at infectious disease related US Food and Drug Administration (FDA) news from the week of March 24, 2019.

Vela Diagnostics Submits HIV Genotyping Assay for FDA Approval

On Tuesday, March 26, 2019, Vela Diagnostic announced the submission of the Sentosa SQ HIV Genotyping Assay to the FDA.

The assay is a next generation sequencing genotyping and drug resistance mutation (DRM) detection test that is being developed to play a role in monitoring and treating HIV-1 infection.

The test uses plasma from HIV patients to detect resistance in the protease, reverse transcriptase, and integrase regions of the pol gene.

The assay uses a workflow that permits automated RNA extraction along with “library construction, template preparation, sequencing, data analysis, and automated reporting,” the company announced. Following extraction, the system generates a report based on the detected mutations and provides information on drug resistance.

According to the company, the assay is highly sensitive and can provide results with reduced turnaround time compared to alternatives.

“Resistance of HIV to antiretroviral drugs as a result of DRMs is the most common cause of therapeutic failure in people infected with HIV…However, almost all molecular diagnostics tests for HIV [drug resistance] are currently unavailable in the in vitro diagnostics market. The submission of the Sentosa SQ HIV Genotyping Assay to the FDA by Vela Diagnostics is a step forward in bringing molecular diagnostics for HIVDR to patients,” the company statement concludes.

The full press release is available here.

FDA Grants Fast Track Designation to SPR994 FOR cUTI and Acute Pyelonephritis

On Friday, March 29, 2019, Spero Therapeutics announced that the FDA granted Fast Track Designation status to SPR994, a candidate being developed to treat complicated urinary tract infections (cUTI) and acute pyelonephritis. The candidate is an oral formulation of a carbapenem antibiotic tebipenem.

The candidate will be evaluated in a phase 3 clinical trial ADAPT-PO, which will compare SPR994 with the current standard-of-care ertapenem. Initial activities for the trial have begun and the company reports that trial sites supporting study enrollment will open in late March.

Under the Fast Track Program, SPR994 is eligible for Accelerated Approval and Priority Review should eligible criteria be met. The candidate previously received Quality Infectious Disease Product designation and will receive FDA priority review of the first marketing application or efficacy supplement.

Pharmacokinetic data from the lead-in cohort from ADAPT-PO is expected in the second half of 2019.

The full press release is available here.