A biopharma company founded by a University of Cincinnati scientist has cleared a major hurdle with the Food and Drug Administration as it looks to launch a study for one of its lead products.
Amplicore, a Mason-based biopharma startup developing drugs for musculoskeletal disorders, said July 14 the FDA cleared its investigational new drug, or IND, application for AM3101, a novel injectable treatment for acute meniscal tears.
The move means Amplicore can start recruitment for its first clinical study. It also marks the company's transition from an early-stage to clinical-stage company, a significant step in terms of drug development success and fundraising efforts.
Dr. James Lin, Amplicore’s CEO and founder, called the news a critical development for “all patients suffering from musculoskeletal conditions."
The clinical study, a phase 1/2B, is being sponsored by the U.S. Department of Defense in concert with the University of Cincinnati. The company was one of the first startups to come out of UC's Venture Lab.
Amplicore received a $2 million grant from the DOD in 2019 to help fund the clinical trial.
"Despite their commonality, service men and women have limited treatment options for acute meniscal tears,” Lin said in a release. “While suturing is the most frequent approach, the failure rate for surgery is quite high due to the limited reparative capacity of much of the tissue. Our research has found that our active pharmaceutical ingredient provides pain relief and promotes regeneration of the meniscus, as well as several other structurally related joint tissues."
Amplicore will recruit 74 patients initially for the study with plans to expand that number, Tyler Vandivort, the company’s director of regulatory affairs and operations, told me. UC will be the main clinic site, along with Walter Reed National Military Medical Center in Bethesda, Md. The company could recruit patients as early as the end of the third quarter, pending institutional review board approvals.
Lin founded Amplicore in 2018 based on technology he developed in laboratories at UC, and the company initially took residence in UC’s Venture Lab, a pre-accelerator housed at the 1819 Innovation Hub. Lin is still affiliated with UC, and the company moved to Mason’s Tech Elevator in early 2020. It has a team of eight.
Moving a drug to clinical stage substantially increases the likelihood it will ultimately make it to market. It’s also key for companies developing other products in their pipeline, and increases investor interest.
In addition to AM3101, Amplicore’s pipeline also includes AM1101, which is being developed for osteoarthritis, and AM2101, which has an indication to treat degenerative disc disease.
The drugs Amplicore is developing, called novel injectable therapeutics, are different, Lin said, because they are minimally invasive and have the potential to facilitate healing or to slow degenerative progression. Current therapies for conditions like osteoarthritis, cartilage damage, disc disease and acute meniscus tear are largely palliative, or offer only short-term relief.
So far, the company has raised $6 million in funding, including a $4 million seed round in March 2021 led by Photon Fund and other West Coast- and Asian-based firms.
Lin confirmed earlier this year the company was looking to add a $30 million Series A to facilitate growth.
Steve Schrader, who most recently served as CFO at Sharonville-based Workhorse (Nasdaq: WKHS), a headline-making manufacturer of last-mile electric vehicles and drones, will assist with those financial planning and fundraising efforts. Amplicore also announced his addition to its advisory board last week.
Schrader also has held CFO positions in a variety of other industries, including Fuyao Glass America, an international auto glass company; Linwood-based Oncology Hematology Care, a private health care company; and Duke Energy, a Fortune 500 public utility.
In his career, Schrader has increased revenue and raised more than $1.3 billion in capital for companies and has also taken two firms from startup to manufacturing stage.
“Amplicore is a leader. I am excited to join during this pivotal time as they work to close their Series A, and I look forward to being a part of their future success,” Schrader said in the release.
