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Remdesivir heads for FDA review as Gilead continues to build manufacturing pipeline 

Plus data from Omeros, PTC and a call to make mAbs accessible

Aug 11, 2020 | 2:38 AM GMT

As Gilead continues to expand its manufacturing capabilities for Veklury, the company has moved a step closer to gaining full approval of the therapy in the U.S. for COVID-19. The company announced its NDA submission for the antiviral on a day that saw shares of Omeros rise 51% on the heels of positive COVID-19-associated acute respiratory distress syndrome data and IAVI and Wellcome issue a call to improve global access to mAbs for COVID-19 and more.    

Veklury remdesivir has been available in the U.S. under an EUA since May 1 for patients hospitalized with severe COVID-19; a week later Japan’s  Ministry of Health, Labour and Welfare approved the Gilead Sciences Inc. (NASDAQ:GILD) drug via an exceptional approval pathway due to the pandemic. The European Commission approved the therapy on July 3.

Gilead’s submission to FDA completes a rolling NDA that began on April 8 and is supported by data from three randomized controlled trials: a pair of open-label studies run by Gilead and the placebo-controlled ACTT study conducted by the National Institute of Allergy and Infectious Diseases (NIAID), which enrolled 1,062 patients (see “Remdesivir’s Challenge”).

Last week, the company annnounced that Pfizer Inc. (NYSE:PFE) will manufacture doses of Veklury at its Kansas facility. Financial terms and dose capacity were not disclosed. The deal came shortly after 34 U.S. attorneys general  urged FDA and NIH to license remdesivir to a third party to increase production of the antiviral and lower its $520-per-vial price tag (see “Gilead Disputes Need for March-in Rights”).

Narsoplimab helps six recover from ARDS 

 Omeros Corp. (NASDAQ:OMER) rose $7.19  to $21.32 Monday after the company reported that treatment with narsoplimab in patients with COVID-19-associated acute respiratory distress syndrome (ARDS) requiring mechanical ventilation resulted in recovery of the six patients tested.

In the single-arm study,  COVID-19 patients with ARDS requiring continuous positive airway pressure (four patients) or intubation (two patients) received the mAb against MASP2 under a compassionate use program at Papa Giovanni XXIII Hospital in Bergamo, Italy.

Dosing occurred twice weekly for two to four weeks and all narsoplimab-treated patients recovered. Median follow-up was 27 days from treatment to discharge, with a range of 16-90 days.

Reported in Immunobiology, narsoplimab reduced circulating endothelial cell counts and serum levels of IL-6, IL-8, CRP and LDH, indicating the therapy may reduce endothelial cell damage, inflammation and thrombosis.

The therapy was well tolerated, with no adverse drug reactions reported.

There are several limitations to the small study. For example, five of six patients took a steroid in addition to narsoplimab; the RECOVERY trial showed that dexamethasone alone reduced deaths by 35% in ventilated patients and by 20% in patients on oxygen support (see “U.K. Approves Steroid”).

After market close, Omeros proposed to raise $125 million through a follow-on and $200 million through the sale of convertible senior notes due in 2026.

PTC’s DHODH inhibitor

In a bioRxiv preprint, PTC299 inhibited SARS-CoV-2 replication in vitro. Developed by PTC Therapeutics Inc. (NASDAQ:PTCT), PTC299 is DHODH inhibitor in a Phase II/III trial to treat patients hospitalized with COVID-19.

The researchers found that PTC299 also suppresses the production of inflammatory cytokines such as IL-6, IL-17A, IL-17F and VEGF in co-cell culture systems modeling general disease states such as chronic T cell activation.

A call to action for accessible mAbs

The International AIDS Vaccine Initiative (IAVI) and Wellcome Trust issued a global call to action to make mAbs for COVID-19 and other diseases more accessible, especially to people living in low- and middle-income countries.

The plan aims to increase awareness of the benefit of mAbs, develop regulatory pathways to increase their availability, implement new technologies to lower development costs and create new business models to enable innovative market approaches in low- and middle-income countries.

The organizations plan to hold a series of meetings over the next year to flesh out an actionable road map for biopharmaceutical companies,  global health agencies, academic institutions, philanthropic organizations and governments.

CRP - C-reactive protein

DHODH - Dihydroorotate dehydrogenase

IL-6 - Interleukin-6

IL-8 (CXCL8) - Interleukin-8

IL-17A - Interleukin-17A

IL-17F - Interleukin-17F

LDH - Lactate dehydrogenase

MASP2 -Mannan binding lectin serine peptidase 2

VEGF - Vascular endothelial growth factor

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