Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) has announced that it has submitted a Clinical Trial Application to the National Agency of Medicines and Medical devices of Romania for the commencement of phase 1a/b trans sodium crocetinate (TSC) study in the treatment of COVID-19.
Using TSC to treat low oxygen levels in COVID-19 patients
TSC is the company’s proprietary oxygenation-enhancing treatment candidate for treating hospitalized COVID-19 patients showing severe respiratory signs as well as low levels of oxygen. COVID-19 causes damage to the lungs, so patients will experience low oxygen levels that require mechanical ventilation. When this is ineffective, multiple organ failure results which is the main cause of death in patients with COVID-19.
The company plans to commence the 24 patient phase 1a part of the clinical study at the end of the second quarter of 2020. However, this is subject to NAMMD authorizing the CTA and National ethics committee’s approval under the accelerated 7-working-day approval process. The full phase 1a/b study will enroll around 224 patients and will be conducted over 12 months. The first data readout of the first 24 patients will be released in Q3 2020 with a preliminary data readout of 50 patients following in Q4 2020.
ARENSIA To Facilitate the study in Europe
ARENSIA Exploratory Medicine GmbH will facilitate the study in Europe which will be carried at the Romanian National Institute of Infectious Diseases (NIID) in Bucharest. Professor Adrian Streinu-Cercel, the Managing Director of the institute and a leading infectious disease researcher, will be the investigator in the study. The phase 1a will be a dose-finding, pharmacodynamics/pharmacokinetic lead study evaluating TSC in 24 non ventilated hospitalized COVID-19 patients with reported oxygen deficiency.
Once complete and a data readout of the phase 1a is available, the company will initiate the 1b phase adaptive design study that will enroll 200 patients. The phase 1b study will be a double-blind placebo-controlled randomized study with the enrollment of patients and observation that is expected to be complete by Q1 2021 and data readout available by Q2 2021.