The enrolment of several subjects in the Hepion Pharmaceuticals Inc (NASDAQ:HEPA) Phase 1b multiple ascending dose (“MAD”) study focusing on CRV431 was a step towards the right direction. This company is pleased to pronounce the completion of the study’s CRV431 dosing among all the subjects involved.
The purpose of conducting the open-label MAD study
It was important to assess aspects such as the pharmacokinetics, tolerability, and the safety of CRV431. That was the reason the company decided to conduct the open-label MAD study, in which case the product was administered orally to the volunteers who, according to sources, were in a healthy condition.
The administration was done once daily, ongoing for 28 days. The doses under examination, in this case, were 75 mg, 150 mg, 225 mg, 300 mg, and 375 mg.
Discoveries in line with the trials
Hepion’s Senior Vice-President in Clinical Pharmacology, called Patrick Mayo, disclosed that CRV431 could tolerate all the dosing levels. The official says that they are hoping to obtain the final data from the study anytime soon.
Hepion’s Consultant Medical Director called Dr. Stephen Harrison says that the company’s ongoing Phase 2a NASH trial has a very strong basis. According to the official, it is linked to the tolerability of the study’s CRV431 that was witnessed in Phase 1 MAD study. He also discloses that the Phase 2a trial patients are receiving 75 mg CRV431 or placebo every day, which will be going on for the next 28 days. The administration is going to be an oral one, according to him.
This official clings on to their Phase 1 MAD study outcomes and the non-clinical programs, outlining that they inspire great confidence. Harrison says that it is a good thing that they are still operating within the sort of dosing range that remains well-tolerated.
Hepion’s CEO, Dr. Robert Foster, is pleased that the company came up with a strategic decision targeted towards initiating the company’s Phase 2a ‘AMBITION’ trial. This one will be moving parallel to the company’s Phase 1b trial, which, according to him, helped save a great deal of time and resources.