Algernon Pharmaceuticals updates on progress of Phase 2b final data from coronavirus trial
Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF) (FRA:AGW), the drug repurposing company, updated on the progress of releasing its final data set from the Phase 2b part of its Phase 2b/3 trial to assess Ifenprodil as a potential coronavirus (COVID-19) treatment.
“The company reports that due to a fire at the Romanian Hospital site, there was a delay in completing the site audit as planned,” Algernon said in a statement on Wednesday.
READ: Algernon Pharmaceuticals mulls lung scarring as additional endpoint for Phase 2b/3 coronavirus trial of Ifenprodil
“However the company is pleased to report that the source data audit from all sites and for all patients is now complete. The database will be locked for analysis on March 5th and the company will update the market on the final data release shortly thereafter,” it added.
In addition, the company confirmed that a “significant number of patients in the study did receive some form of an imaging scan as part of their release protocol from the hospital”.
“While Algernon believes the data may be helpful in establishing Ifenprodil’s possible role in reducing post-COVID infection lung scarring, in order to ensure the final data process is not delayed further, the data will be reviewed as supplemental, at a later date,” it said.
Earlier this year, Algernon said that if the final set of data was positive, it would look to get emergency use authorization (EUA) from the US FDA.
A Phase 3 trial would be required regardless of whether or not it receives an EUA.
Algernon reckons Ifenprodil may reduce the infiltration of neutrophils and T-cells into the lungs, where they can release glutamate and cytokines respectively.
The latter can result in the problematic so-called cytokine storm that contributes to the loss of lung function and ultimately death as has been reported in coronavirus infected patients.
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Story by ProactiveInvestors
Source: http://www.proactiveinvestors.com/companies/news/941571/algernon-pharmaceuticals-updates-on-progress-of-phase-2b-final-data-from-coronavirus-trial-941571.html
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