JanOne Inc., a company specializing in development of treatments for conditions causing severe pain, has confirmed stability of its JAN101 developmental batch run.
Working with bottling and labeling partner Eurofins CDMO, the company is poised to initiate GMP production of the drug to support Phase IIb trials of peripheral artery disease (PAD); it also plans to have required clinical batches of properly bottled and labeled product to support clinical research for use of the drug as a potential COVID-19 treatment for vascular complications, pending IND approval.
Eurofins CDMO, which provides pharmaceutical development services to clients around the globe, plans to work with JanOne through its Canadian facility, Alphora Research Inc. The company reportedly will collaborate with the JanOne clinical teams and manufacturing partner to ensure the integrity of all active and placebo bottles of JAN101.
The trial calls for precise randomized packaging and labeling, so that patients and caregivers are unaware of whether they are receiving the placebo or active formulation. In addition, the trial requires accurate participant tracking and clinical data collection.
Business development executive for Eurofins CDMO/Alphora Research Inc. Stefan Soderman said, "We are very pleased to support JanOne's project to treat vascular conditions. We are looking forward to a long-term relationship with the company."
The company expects that the IND for JAN101 as a COVID-19 vascular complication treatment will be submitted to the US Food and Drug Administration (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 reportedly is on track for its PAD Phase 2b clinical trials expected to begin in early 2021.
Earlier this year, Eurofins Discovery, the company’s drug discovery services provider section, announced a partnership with Chinese contract research organization (CRO) PharmaResources on a platform designed to speed clinical development of small-molecule drugs.