Doron Therapeutics raises $11M to advance osteoarthritis biologic into Phase 3 trials
With an aggregate of $11 million raised in an initial Series A funding round, Doron Therapeutics is advancing its lead biologic drug, MOTYS, into Phase 3 clinical studies for symptomatic knee osteoarthritis. The funding signals a fresh chapter for the clinical-stage biotech company, which focuses on degenerative musculoskeletal conditions.
SPRIM Global Investments (SGI), a prominent health sciences investment firm, is leading the funding round. SPRIM specializes in helping companies that are beyond proof of concept and need confirmatory clinical evidence, such as Phase 2 or early Phase 3 trials, by blending loan and equity components for funding.
"We are grateful to our Series A investors and their confidence in our initiative," said Alessandra Pavesio, CEO and co-founder of Doron. “This is an exciting time for Doron. We believe MOTYS will allow patients to have reduced pain and regain function, allowing them to get back to healthy and active lives."
As part of the funding, Doron Therapeutics welcomed two new board members. Karen Zaderej, former CEO and chairman of Axogen Inc., brings expertise from leading Axogen's transformation into a public company and advancing Avance Nerve Graft through Biologics License Application submission. Joining her is Tassos Konstantinou, managing director at SPRIM, whose extensive background in life science venture capital and global business development adds a diverse and strategic perspective to the board.
New hope for osteoarthritis
Osteoarthritis is on the rise, driven by an aging population and other factors, yet treatment options remain limited. For many, the only option left is a total knee replacement.
MOTYS is a placental tissue-derived therapy that enables a unique multimodal approach to treating osteoarthritis by managing inflammation, delaying degenerative processes and supporting tissue regeneration. Placental tissue — donated by mothers after planned, healthy C-section births — contains a mix of healing and protective molecules that help reduce inflammation, slow joint damage and support tissue repair. Because this tissue naturally avoids triggering an immune response, it is also very safe.
The Phase 1 and 2 MOTYS studies, involving over 350 patients, have demonstrated the treatment's durability, safety and effectiveness. A single intra-articular injection of MOTYS can provide lasting benefits for 9 to 12 months.
From vision to venture
The development of MOTYS began at Durham-based Bioventus, where Pavesio, then chief science officer, along with colleagues Sarah Caley, now head of business development and strategy at Doron, and M.K. Kottke, now head of regulatory and CMC, spearheaded a strategic program to explore the potential of placental-derived tissues. Initiated in 2019, the program advanced rapidly, reaching Phase 2 studies by 2022, thanks to a focused team, strong expertise and significant funding.
However, organizational changes at Bioventus led to a decision to divest from the program. Recognizing the program’s potential, Pavesio and her team negotiated an exclusive worldwide license for the technology.
“We were passionate about this program, and the thought of it ending was out of the question,” said Caley. “Spinning it out as a new company gave us control and the chance to work with Alessandra and build a female-led team. The past 18 months have been tough raising capital for nearly everyone but supporting each other and remaining positive has been key to our progress.”
Forging strength from struggles
As a women-founded and women-led company, Doron Therapeutics has faced significant funding challenges.
“We were successful because we have tremendous passion and grit,” said Pavesio. “It takes much more than knowledge to be successful at this. It takes a lot of drive and resilience. This initial funding means we can restart operations after almost two years of uncertainty.”
The company has already begun manufacturing engineering runs for the drug and is engaging with the FDA for its end-of-Phase 2 meeting. “We're firing on all cylinders to get back on track with the program,” Pavesio added.
Drawing on local resources
Pavesio says that being based in North Carolina has allowed the team to take advantage of the state’s vibrant research and clinical community. For preclinical research, they collaborated with leading experts at the University of North Carolina at Chapel Hill and Duke University researchers for the Phase 1 study.
“The North Carolina Biotechnology Center has also been an incredible resource for us,” she said. “Their librarian services are exceptional, particularly in providing access to (certain research tools)... Kathy Meserve (senior director of investments, NCBiotech) and the team have also been instrumental in connecting us to key biotech meetings and partners, which have been excellent opportunities for networking and growth.”
Doron Therapeutics has also benefited from CRO services from Premier Research in Morrisville and formed a partnership with Novex Innovations, a CDMO in Winston-Salem, to manufacture the proprietary product.
Although the Phase 2 study was conducted internationally to reduce costs and expedite progress, the company plans to bring Phase 3 trials back to the U.S., including some NC sites while incorporating international locations to meet investment requirements. The first patients for the Phase 3 studies will be dosed in mid-2025.