Most of us can claim a scar or two on our bodies. But when scarring develops inside the body, it’s known as a fibrotic disorder. A freshly launched Houston company, Oorja Bio Inc., is working on a treatment that can help to repair cells and reduce the damage wrought by the growth of fibrotic tissue in patients.
Late last month, Oorja Bio hit the scene with a pair of big announcements. Not only has the company raised a $30 million Series A thanks to founding investor California-based Westlake BioPartners, but it has also already paved the way for a Phase 2 study to take place this year.
Oorja Bio received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA), allowing the company to test its treatment in patients with idiopathic pulmonary fibrosis (IPF), a scarring of the lung tissue. IPF affects more than 150,000 adults in the United States and can result in a range of symptoms from shortness of breath to organ failure and death as it progresses.
Oorja Bio’s lead drug candidate, ORJ-001, was shown in a Phase 1 in-human trial to demonstrate “therapeutically relevant exposure and favorable tolerability” in 64 healthy adult volunteers in whom it was administered daily or weekly, according to a news release. Pre-clinical studies of ORJ-001 showed durable target tissue engagement and biomarker activity in bleomycin-induced lung fibrosis.
Administered subcutaneously, ORJ-001 is intended to improve and even restore function in cells that can reduce the signaling that causes IPF. It stops advancement of IPF and also allows for tissue repair. Currently available treatments for the disease can slow the development of IPF down, but do not address the declining lung function that’s inherent in its progression.
“The clinical and preclinical results from our studies to date give us confidence that ORJ-001 represents a novel treatment approach with the potential to repair and reverse fibrosis and modify disease progression in IPF,” Dr. Janethe Pena, CMO of Oorja Bio, said in the release.
“Our team is energized to deliver on our goal of redefining the future of fibrotic diseases, beginning with ORJ-001,” CEO and founder Sujay Kango added. “As we advance ORJ-001 in the clinic, we are embracing the paradigm shift in our biological understanding of IPF pathology that aligns with the central role of the alveolar epithelium. ORJ-001 was designed with this biology in mind and may provide, for the first time, a therapeutic intervention that repairs and reverses fibrosis and promotes disease modification.”
Most patients live only three to five years following their IPF diagnosis. Soon, ORJ-001 and Oorja Bio could give them a fighting chance.
