The ID Pipeline: FDA Activity From the Week of May 12, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of May 12, 2019.

DEINOVE Announces Phase 2 Trial for DNV3837 Antibiotic Candidate for C Diff

On Thursday, May 16, 2019, French biotechnology company DEINOVE announced the upcoming kickoff of a phase 2 clinical trial evaluating DNV3837, a first-in-class antibiotic candidate for the treatment of Clostridium difficile (C diff).

"This multicentric open-label trial will be conducted both in Germany and the United States. Under the updated protocol, the number of sites, necessary for the implementation of its Phase II, has been reached. The inclusion of the first patient is planned for mid-2019," the company said in a statement. "DNV3837 has demonstrated a promising efficacy profile, and acceptable tolerance in Phase I trials. It has obtained a QIDP designation and a Fast Track status."

The full press release is available here.

Emergent BioSolutions Preparing for Delivery of AV7909 Anthrax Vaccine Candidate into the Strategic National Stockpile

On Wednesday, May 15, 2019, Emergent BioSolutions Inc. announced that the Biomedical Advanced Research and Development Authority (BARDA) will being procuring the AV7909 anthrax vaccine candidate for delivery into the Strategic National Stockpile. The company signed a development and procurement contract with BARDA, valued at $1.5 billion, in September 2016.

Emergent launched a phase 3 trial of AV7909, an anthrax vaccine adsorbed with CPG 7909 adjuvant, in March, and submitted an application to the FDA in December 2018 to use the candidate in the event of a public health emergency involving Bacillus anthracis. The vaccine candidate would function as post-exposure prophylaxis of disease resulting from suspected or confirmed exposure, in addition to a course of antimicrobial therapy.

“Emergent is pleased to respond to BARDA’s procurement of AV7909 for delivery into the Strategic National Stockpile representing the initiation of the planned anthrax vaccine transition from BioThrax to AV7909,” Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions, said in a company release. “As discussed during the Q1 earnings call, the timing of this stage of the transition is consistent with our expectations and supports our financial projections and guidance for 2019.”

The full press release is available here.

CytoDyn Inc. Files Pivotal Trial Protocol for Leronlimab HIV Monotherapy

On Wednesday, May 15, 2019, CytoDyn Inc. filed a pivotal trial protocol with the FDA for leronlimab as monotherapy for patients with HIV. Leronlimab (PRO 140) is a CCR5 antagonist with the potential for multiuple therapeutic indications.

"The latest investigative monotherapy trial for HIV has now produced sufficient data for the Company’s Key Opinion Leaders to design a monotherapy pivotal Phase 3 trial," CytoDyn announced in a press release. "The objective of this trial is to assess the treatment strategy and clinical safety of using leronlimab subcutaneous (SC) 700 mg weekly dose as single-agent induction therapy followed by leronlimab SC 525 or 700 mg as maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection."

A successful trial will form the basis of a future BLA for label expansion if leronlimab receives FDA approval for patients with HIV as a combination therapy with HAART.

“As a longstanding investigator for CytoDyn, I have seen that many of our HIV positive patients express a preference for weekly subcutaneous leronlimab monotherapy and uniformly request extension treatment beyond 48 weeks in order to avoid returning to HAART therapy," Jacob P. Lalezari, MD, director of Quest Clinical Research, said in the company statement. "In the minority of subjects who are non-responders, we are heartened by the fact these folks can return to their original HAART regimen without difficulty.”

The full press release is available here.