JanOne Prepares for GMP Production

JanOne Inc., a company focused on developing treatments for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, has confirmed stability of its developmental batch run of JAN101. Working closely with selected bottling and labeling partner, Eurofins CDMO, the company is currently on track to initiate GMP production of JAN101 to support planned Phase 2b trials to treat peripheral artery disease (PAD). Required clinical batches of properly bottled and labeled product will also be available to support immediate start of clinical research to use JAN101 as a potential treatment for Covid-19 vascular complications should JanOne gain FDA IND approval. The company is currently finalizing its Covid-19 vascular treatment investigational new drug application (IND) for submission to the FDA.

Eurofins CDMO is a provider of pharmaceutical development services. Its Canadian facility, Alphora Research Inc., will work with the JanOne clinical teams and manufacturing partner to ensure the integrity of all active and placebo bottles of JAN101. Precise randomized packaging and labeling is required so patients and caregivers are unaware of whether they are receiving the placebo or active formulation but also for accurate participant tracking and clinical data collection.

"We are very pleased to support JanOne's project to treat vascular conditions,” said Stefan Soderman, business development executive, Eurofins CDMO (Alphora Research Inc.). “We are looking forward to a long-term relationship with the company."

It is expected that the IND for JAN101 as a Covid-19 vascular complication treatment will be submitted to the FDA in the coming weeks. Bottling and labeling of clinical trial batches are expected to begin in early October led by Eurofins CDMO. The company remains on track for its PAD Phase 2b clinical trials expected to begin in early 2021.