NeuroRx Inc, a clinical stage, small molecule pharmaceutical company, and Relief Therapeutics Holdings AG (SIX:RLF, OTC:RLFTF), a Swiss-based publicly-traded drug development company, have received US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to test RLF-100 (aviptadil) for inhaled use in the treatment of patients with moderate and severe COVID-19 in order to prevent progression to respiratory failure, it is reported on Thursday.
The first phase is to start with patients hospitalised for severe COVID-19 who do not yet have respiratory failure. If promising results are revealed then the trial will expand to patients at home with mild and moderate COVID-19 in order to prevent the requirement for hospital admission.
The clinical trial of the product's inhaled formulation is likely to commence on or before 1 September 2020.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval