Biora Therapeutics Inc (NASDAQ: BIOR) has announced topline results from the recently finalized study PM-611: Safety and Functionality Assessment of the Drug Delivery System (DDS) Capsule in humans. The purpose of the study was to determine whether a fed state, as opposed to a fasted one, had an effect on the ingestible devices’ ability to locate themselves autonomously.
Study demonstrated no failure modes in all the 39 studied capsules
The investigation showed that no major adverse effects were experienced throughout the safe ingestion and natural elimination of all capsules. No failure modes were found in any of the 39 studied capsules, which all showed the entrance to the intestine, activation, and release regardless of whether the patient was fasting or eating.
CEO Adi Mohanty said, “To our knowledge, there is no currently available ingestible medical device for delivering drug that is designed to be taken with food. These data suggest that the DDS capsule could be the first ingestible therapeutic delivery device that does not require fasting or other food restriction for use. This could be an important consideration for patients who need frequent administration of dosing in chronic diseases like ulcerative colitis.”
Biora to report perfomanxe of PM-602 medicla devoce in Q3 2022
The company has already successfully finished two human investigations, and in the third quarter of 2022, it anticipates reporting on its third human trial, the PM-602 medical device performance trial in chronic ulcerative colitis patients. This is yet another milestone toward the company’s earlier stated objective of starting a phase 1 study by the end of the year.
Numerous dose incidents were included in the PM-611 trial. According to the study’s protocol, subjects had to take a maximum of 4 capsules, each of which had to be taken after the subject had passed the previous one. Twelve participants consumed a total of 46 pills, with one participant taking only two. Performance was assessed using data retrieved from the 43 capsules that were recovered for the study. Thirty-nine capsules with data were successfully retrieved.