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(AWP / RB) Relief Therapeutics Pharmaceutical Company (RLF 0.27 -24.65%) and its partner NeuroRx have completed the recruitment of patients for studies with the compound Zyesami for the treatment of respiratory failure in patients with critical illness Covid-19. The emergency approval requested from the FDA in September was rejected.
The reaction on Wednesday was violent on the stock market. The relief shares lost about half of their value at the start of trading. They were able to partially recover from this diver. The papers closed with a loss of 25%.
Relief Therapeutics announced Wednesday that the original number of 165 patients who participated in the study has increased further. The company announced in early December that the target of 165 patients had been reached. More patients will be recruited until the results are announced to have the largest possible database on side effects. Wednesday’s announcement said that recruitment for the study has now been completed.
Results can be a little later
Over the course of the phase 2b / 3 study to date, there have been no serious adverse effects related to the use of Zyesami (formerly RLF 100, Aviptadil). The results of the study will be published in late January or early February. Relief had previously expected in January.
The US regulatory authority FDA has rejected the approval requested in September for the use of the agent in emergency situations, continues Relief Therapeutics. However, he said he would continue to work closely with Relief on product development and will immediately review upcoming randomized trial data.
Until then, Zyesami’s on-hand stocks would continue to be managed under the extended hardship protocol and for individual patient consultations in accordance with right-to-try laws.
Note: An early version of this article stated that it was new that the target number of study participants would increase even further after the target of 165 people had been reached. Relief had announced at the time that it would recruit additional patients for safety data.
