Shionogi, a Japanese pharmaceutical company developing Covid-19 treatment S-217622 jointly with Ildong Pharmaceutical, said the recent controversy over the treatment’s potential harm in an animal study would not affect the drug approval.
Earlier, Japanese news reports said that the company’s investigational Covid-19 treatment caused fetal abnormalities in a study on animals.
On Wednesday, Shionogi issued a note on its website after Japanese media reports said the experimental Covid-19 treatment might disturb fetal development.
Shionogi applied for conditional approval for S-217622 to the Pharmaceuticals and Medical Devices Agency on Feb. 25.
The company said in the statement that it received a request on April 4 from a Japanese wire service agency to confirm information regarding non-clinical data of S-217622 and present the company’s view.
“The information was that fetal skeletal morphological abnormalities were observed in the non-clinical safety study of S-217622. Therefore, on April 6, we responded that such observations occurred and shared our assessment of the meaning of these non-clinical results from a clinical perspective,” Shionogi said.
Shionogi reported the results of the non-clinical study to the Ministry of Health, Labor and Welfare (MHLW) and PMDA in December 2021. The company said that the results were also included in the approval application submitted on Feb. 25.
“The results do not constitute new information arising at this media coverage,” it added.
Shionogi also explained the results of the non-clinical study additionally in the statement.
The non-clinical study was one of the regulatory safety trials. Shionogi said that the results were obtained at doses higher than the clinical dose, exceeding the expected human blood concentration and administration period.
As pregnant, lactating, or potentially pregnant women are usually excluded from clinical trials, the latest study of S-217622 also did so, the company said.
“The results from this non-clinical study were promptly reported to the medical institutions conducting the clinical trial. Clinical subjects were informed of risk-related information, including this result, and then participated in the clinical trial after their informed consent,” Shionogi argued.
The clinical implications of the non-clinical study and whether to administer S-217622 to pregnant women will be judged by the PMDA. According to the company, the comprehensive judgment will be noted in the attached document.
“Based on the above, Shionogi believes that this matter would not affect the decision for approval of S-217622,” Shionogi said.
It emphasized that the company would continue to cooperate with the PMDA’s review and collect further information on safety and efficacy in ongoing trials.
In Korea, Ildong Pharmaceutical is conducting a phase 2/3 study of S-217622 as part of a multinational trial.