- Algernon Pharmaceuticals (AGN) to file end-of-Phase 2 meeting request with U.S. FDA for a possible Ifenprodil Phase 3 COVID-19 trial
- Algernon has now completed its initial review of the data from the study and will be seeking guidance from the FDA
- Algernon is preparing a briefing package that includes a summary of study data and a protocol synopsis
- Algernon is a drug re-purposing company that investigates well-tolerated and already approved drugs
- Algernon Pharmaceuticals Inc. (AGN) is down 2.56 per cent and is trading at C$0.19 at 10:55 am ET
Algernon Pharmaceuticals Inc. (AGN) is planning discussions with the U.S. Food and Drug Administration regarding an Ifenprodil Phase 3 COVID-19 trial.
Algernon will be filing an End-of-Phase 2 meeting request based on completing Phase 2b part of its Phase 2b/3 COVID-19 trial of NP-120 (Ifenprodil).
Algernon has now completed its initial review of the full data set from the study and will be seeking guidance from the FDA on moving forward with a potential Phase 3 study.
The purpose of an EOP2 meeting is to facilitate interaction between the FDA and sponsors who seek guidance related to clinical trial design, to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan.
This evaluation includes protocols and endpoints for adequacy, and to identify the information necessary to support a marketing application.
As part of the EOP2 meeting request, Algernon is preparing a briefing package that includes a summary of study data and a protocol synopsis for a potential Phase 3 trial.
The EOP2 meeting is an essential part of the process to help Algernon and determine the next steps forward.
The EOP2 meeting will focus on the data from three key endpoints from the study, including all-cause mortality, oxygenation (SpO2) and time in ICU, from the 20mg Ifenprodil treatment arm.
Algernon has been reviewing the data from the 40mg Ifenprodil treatment arm of the study.
While the full data set review confirmed no significant changes were observed compared to the study’s untreated arm, the data showed a negative dose-effect trend with some clinical outcomes.
As a complex receptor, NMDA’s relationship with drugs that stimulate or inhibit it is not completely understood.
In some cases of being inhibited or antagonized, the receptor, instead of shutting down, appears to protest over-inhibition, possibly leading to patients’ adverse responses.
This has been identified in studies of Memantine and Ketamine, also NMDA receptor antagonists.
This may represent a class effect observed at doses higher than those at which a more customary dose-response relationship is shown, and as such, may inform observations on the 40mg dose data.
There was very little historical data to guide dosing for this study of Ifenprodil in COVID-19 patients, and Algernon chose to include a high dose 40mg treatment arm in the study, given Ifenprodil’s considerable safety record.
“When we consider the totality of the study’s data set, we are very confident that the next appropriate step is a formal EOP2 meeting with the FDA to discuss the results and explore the potential of a Phase 3 trial,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals.
“We look forward to feedback from the FDA so that we can determine our next steps,” added Moreau.
Algernon advises that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 at this time.
Algernon is a drug re-purposing company that investigates well-tolerated, already approved drugs, including naturally occurring compounds for new disease applications, moving them efficiently and safely into new human trials, developing new formulations seeking new regulatory approvals in global markets.
Algernon Pharmaceuticals Inc. (AGN) is down 2.56 per cent and is trading at C$0.19 at 10:55 am ET.