JanOne Inc. (NASDAQ: JAN) stock gained by 7.54% at last close whereas the JAN stock price declines by 5.26% in the after-hours trading session. JanOne is dedicated to the research and development of therapies for illnesses that cause excruciating pain. JanOne seeks to decrease the need for opioid prescriptions to manage disease-related pain, which can lead to opioid misuse, by addressing pain at its source.
JAN stock’ Current Update
Looking at recent interactions with the US Food and Drug Administration for its forthcoming clinical trial of main drug candidate JAN101 as a therapy for Peripheral Artery Disease, JanOne stated that it is changing its development approach. JanOne had previously submitted results from the product’s Phase 1 and Phase 2a trials, which showed better vascular function and pain reduction and were incorporated into the Phase 2b procedures and main and secondary objectives. The FDA examined the data and presented JanOne with suggestions and remarks regarding the proposed clinical study.
Tony Giordano, Chief Scientific Officer of JanOne stated,
The FDA’s comprehensive evaluation of their pre-Phase 2b briefing materials has made them extremely delighted. They’re currently working with their collaborators to include all of the FDA’s suggestions and comments into their Phase 2b protocol and supporting documentation, which they believe will result in a significantly better trial. Their goal is to get a medication to market as quickly as feasible so that they may begin treating patients with PAD and offer them with a therapeutic benefit that is unavailable for now.
Moreover,
JAN101 is a slow-release version of the FDA-approved chemical therapeutic sodium nitrite that is taken twice a day orally. The use of sodium nitrite for the control and diagnosis of PAD is supported by results from JAN101’s Phase 2a clinical studies. Some patients reported a considerable reduction in PAD-related pain, which was an unanticipated result of the Company’s prior research. JanOne developed clinical procedures for PAD and PAD-associated pain for Phase 2b studies as a result of this.
