Shinpoong redesigns P1 trial of cardiovascular drug

Shinpoong Pharmaceutical said it was redesigning the phase 1 clinical trial of SP-8356, a treatment for intractable cardiovascular disease, in the U.K.

According to ClinicalTrials.gov, a clinical information site of the U.S. National Institutes of Health (NIH), Shinpoong Pharmaceutical terminated the U.K. phase 1 trial which had aimed to evaluate the safety and pharmacokinetics of SP-8356 on 31 healthy males.

The company had been conducting the study since January 2021.

The study consisted of two parts – a single ascending dose  in Part 1 and multiple ascending dose in Part 2.

During Part 1 of the trial, the company aimed to derive the maximum tolerated dose by increasing the dose until a safety or tolerability problem occurrs.

Regarding the reason for the termination, the company stressed that it only conducted Part 1 of the trial and not Part 2, and due to the low exposures, it could not make definitive safety conclusions for the targeted exposure levels.

“The company has not given up on developing SP-8356, and phase 1 trial is currently progressing after changing the clinical design, which is a common occurrence in phase 1 trials,” a company official said. “However, it is difficult to disclose which part has been changed.”

SP-8356 is a drug with a mechanism to control the signaling pathway of cluster difference 147 (CD147) that induces the activity of Matrix metalloproteinase, a matrix-degrading enzyme that destroys matrix proteins in vascular endothelial cells in stroke and arteriosclerosis.

Shinpoong Pharmaceutical received clinical approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in December 2020. Quotient Sciences, a clinical institution, led the trial.