ID Trial & Pipeline News: Week of May 10, 2020

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of May 10, 2020.

FDA Approves Umbilical Cord Stem Cell Trial for Severe COVID-19 Care

The US Food and Drug Administration (FDA) has approved the start of a phase 1/2a trial assessing the use of umbilical cord mesenchymal stem cells for treating patients with severe coronavirus 2019 (COVID-19).

The 60-patient study from cell-based therapeutics company RESTEM will be the first of its kind in the US.

The cells used in RESTEM therapy candidates are grown from umbilical cord tissue through a proprietary process that replicates millions of doses in rapid succession. The Systemic Umbilical Cord Cells to Ease Severe Syndrome with COVID-19 (SUCCESS) trial will identify hospitalized patients with confirmed COVID-19 and acute respiratory distress syndrome (ARDS) who could be best benefit from the therapy.

The randomized, blinded, placebo-controlled study will look at whether umbilical cord lining stem cell therapy may be a safe and effective treatment for patients hospitalized with severe cases of COVID-19.

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FDA Grants Coronavirus mRNA Vaccine Fast Track Designation

Moderna’s coronavirus disease 2019 (COVID-19) vaccine candidate mRNA-1273 has been granted Fast Track designation by the US Food and Drug Administration (FDA), according to a company press release.

The investigational mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the coronavirus’ Spike protein.

A fast track designation expedites review for treatments which fill an unmet medical need. The designation encourages communication between drug developers and the FDA. Moderna previously received Fast Track designation for an investigational Zika vaccine.

“Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” Tal Zaks, MD, PhD, Chief Medical Officer at Moderna, said in the press release.

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COVID-19 Treatment Candidate ABX464 Shows Promise In Vitro

Clinical-stage biotechnology company Abivax SA announced preliminary results of its drug candidate ABX464 against SARS-CoV-2 in a press release today. In an in vitro reconstituted human respiratory epithelium model, the investigational drug inhibited replication of the novel coronavirus.

While the results are a very early indicator, findings support further exploration of the candidate.

Antiviral testing was conducted at the International Research Center specialized in infectiology at Claude-Bernard-Lyon-1 University, VirPath laboratory.

“Although in vitro results cannot predict clinical benefits in patients, this antiviral effect against SARS-CoV-2 with ABX464 obtained in our laboratory is very promising, in addition to the known anti-inflammatory properties. ABX464’s antiviral effect and protection of tissue integrity are significant as they are based on a physiologic in vitro reconstituted human pulmonary epithelium model and not on the more basic monkey kidney Vero E6 cells model,” said Manuel Rosa-Calatrava, PhD, VirPath Co-director at the International Center for Infectiology Research in Lyon, France, in the press release.

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FDA Provides Guidances to Streamline COVID-19 Trial Applications

The US Food and Drug Administration (FDA) has provided new guidance with recommendations for developers and investigators working to provide preventive and therapeutic agents during the coronavirus 2019 (COVID-19) pandemic.

The guidance, shared on May 12, provide a streamlined process for new drug and biologic product application submissions, as well as recommendations for clinical trial design that emphasize safety and efficacy for treating COVID-19.

The first guidance, titled “COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products,” outlines the process established for developers to sooner receive the FDA’s feedback on supporting data for INDs.

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