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Relief Therapeutics seeks US emergency approval for COVID-19 drug

If granted, EUA would give approval for use in severely ill patients with no other treatment options

Relief Therapeutics and its development partner NeuroRx have announced the submission of their potential COVID-19 med to the US Food and Drug Administration (FDA), seeking an emergency use authorisation (EUA).

The companies are requesting an approval for RLF-100 (aviptadil) as a treatment for COVID-19 patients who are receiving intensive care and who have exhausted all approved treatments.

The EUA submission is based on a 51-person study that compared RLF-100 to those receiving maximal standard-of-care treatment in the same intensive care unit by the same medical staff.

According to Relief Therapeutics, patients treated with RLF-100 demonstrated a three-fold advantage in survival, as well as recovery from respiratory failure and other clinical improvement parameters.

In other initial findings, patients treated with Relief Therapeutics and NeuroRx’s experimental drug were found to have a rapid clearing of classic pneumonitis findings on x-ray, as well as an improvement in blood oxygen and a 50% or greater average decrease in laboratory markers associated with COVID-19 inflammation.

“The EUA application covers the same type of patients whom FDA has already allowed to receive treatment under the Expanded Access protocol authorised by the Agency in July,” said Jonathan Javitt, chairman and chief executive officer of NeuroRx.

“Tragically, we have found that many patients who might benefit from the Expanded Access protocol are hospitalised in centres that do not allow patients access to investigational drugs,” he added.

RLF-100 is a formulation of vasoactive intestinal polypeptide (VIP), which is known to be highly concentrated in the lungs and thought to inhibit a number of inflammatory cytokines.

VIP has been shown in over 100 peer-reviewed studies to have significant anti-inflammatory activity in animal models of respiratory distress, acute lung injury and inflammation.

COVID-related death is often linked to an over-active inflammatory response, known as cytokine storm, which causes the body’s reaction to the infection to go into overdrive. This hyper inflammation can seriously harm and cause death in patients with COVID-19.

“We continue to work tirelessly with our partner NeuroRx to bring this potentially life-saving drug to patients afflicted with severe complications of COVID-19 infection as quickly as possible. The pursuit of EUA status is a crucial component of this effort,” said Raghuram Selvaraju, chairman of the board of Relief Therapeutics.

Article by
Lucy Parsons

23rd September 2020

From: Regulatory

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