SAN DIEGO – Biosplice Therapeutics is poised to receive regulatory approval for the lead drug candidate in its pipeline in 2026 following the submission of a New Drug Application to the U.S. Food and Drug Administration.
Biosplice has studied lorecivivint, a knee joint injection for the treatment of osteoarthritis, across 11 clinical trials, including a two-year Phase 3 study that found non-placebo patients had less pain after six months of treatment and improved pain and knee function after 12 months.
If approved, according to Biosplice CEO Erich Horsley, lorecivivint would be the first novel drug approved for the treatment of osteoarthritis since 1998.
“That’s an incredibly long time for long-suffering patients to go without any innovation,” Horsley said, adding, “it’s a very difficult area to develop in.”
Osteoarthritis is the most common form of arthritis and primary affects joints in the hands, knees, hips and spine as cartilage between bones wears away, causing bones to rub against each other. Some 25 million people in the U.S. suffer from knee osteoarthritis in particular.
Orthopedists measure the loss of cartilage, the width of cartilage within affected joints and progression of osteoarthritis via X-ray, according to Horsley.
“These measurements are done with a central radiologist, so it’s a very objective measure,” he said. “You can’t fake joint space width, and there’s a little noise in the X-ray, which is why you need a robust number of patients.”
The first year of the study compared osteoarthritis patients’ response to lorecivivint relative to a control group that received a placebo, which showed a standard decrease in cartilage between the femur and tibia.
After the first year, the placebo group was then shifted into the patient population and received lorcivivint for the study’s second year. Those patients demonstrated a reversal of their first-year arthritis progression and an increase of space between the bones in their knee joint.
“The placebo patients, their pain dropped as well as you might expect,” Horsley said. “So it was a very robust but very difficult (trial) design, it took us years to put this in place.”
$15B Global Opportunity
The development path for lorecivivint has been arduous, as Biosplice first synthesized and identified the compound in 2011. The drug, which is administered via injection once or twice per year, inhibits two enzymes that play significant roles in inflammation and the breakdown of cartilage.
Biosplice expects the FDA to accept its NDA submission for review by March, according to Horsley. The agency’s review could then take between six and 10 months depending on how the application is prioritized.
If approved, lorecivivint could ultimately become a $15 billion drug globally, as nearly 700 million people worldwide suffer from osteoarthritis, and a significant majority suffer from knee osteoarthritis.
Biosplice is considering multiple options for the drug’s potential commercialization, including establishing a partnership with a larger pharmaceutical company as it already has in Korea and China. However, the company may raise a crossover funding round later this year and commercialize lorecivivint domestically on its own.
“I’m a private equity guy by background, I’ve built a lot of companies,” Horsley said. “So I’m not afraid of building a commercial presence and it would be really fun to do this, so we’re kind of parallel pathing it.”
For many osteoarthritis patients, the typical prescribed treatment is the use of nonsteroidal anti-inflammatory drugs like ibuprofen and celecoxib, known commercially as Celebrex, but those are often only temporary solutions, Horsley argued.
Patients with advanced osteoarthritis can also have their knee joints replaced, but those replacements often only last 15-20 years and doctors typically wait until patients are older than 65 as a result.
However, 54% of all osteoarthritis patients are diagnosed when they are younger than 65, according to Horsley, who was diagnosed in his 40s.
“There hasn’t ever been a drug that has shown significant improvement in joint structure over a two-year period like we have,” he said. “It’s incredibly unique and was really hard to get that data, took a long time and a lot of capital.
“But the opportunity for patients is what we’re really focused on, and as an OA patient myself, I just can’t tell you how excited I am to bring this to market,” he said.
Biosplice Therapeutics
FOUNDED: 2008 as Samumed, rebranded as Biosplice in 2021
CEO: Erich Horsley
HEADQUARTERS: San Diego
BUSINESS: Clinical-stage small-molecule-based drug developer.
EMPLOYEES: Around 20
WEBSITE: biosplice.com
CONTACT: [email protected]
Eli is an award-winning reporter primarily covering the tech and life sciences industries. He previously worked as the San Diego City Hall reporter for the regional wire City News Service. He has also covered public health, transportation and state and local politics in the San Francisco Bay Area for Local News Matters, the nonprofit arm of the regional wire Bay City News Service, where he also oversaw the development and daily content management of the outlet’s public health and COVID-19 news and resource webpage. He is also a contributing writer covering Minor League Baseball for the analysis and commentary website Baseball Prospectus. Eli is a graduate of San Francisco State University and a native of Northern California.
