Pluri Inc. announced that a €7.5 million non-dilutive grant from the European Union's Horizon Europe program has been awarded to PROTO (Advanced PeRsOnalized Therapies for Osteoarthritis), an international collaboration led by Charité, Berlin Institute of Health Center for Regenerative Therapies. The goal of the PROTO project is to utilize Pluri's PLX-PAD cells in a Phase I/IIa study for the treatment of mild to moderate knee osteoarthritis (OA). The project is currently under grant agreement preparation number 101095635.

Final approval of the grant is subject to completion of the consortium and Horizon Europe grant agreements. The funds from the grant are expected to be allocated between Pluri and other members of the consortium in accordance with budget and work packages which will be determined by the consortium. The Phase I/IIa study will be carried out by Charité, Pluri and other members of the international consortium under the leadership of Professor Tobias Winkler, Principal Investigator (PI) at the Berlin Institute of Health Center for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery.

Professor Winkler was also the lead PI in the Phase II and Phase III muscle regeneration studies using Pluri's PLX-PAD cells. OA is one of the most common chronic articular diseases, with a global prevalence of 16% in the adult population. OA is the third most rapidly growing disease associated with disability2, showing an increase of 30% over the past decade, currently affecting more than 500 million people worldwide and about 50 million in Europe.

Globally, symptomatic OA affects 10% of men and 18% of women over 60 years of age, with knee being most the commonly affected joint4. OA also represents a huge healthcare burden with U.S. indirect costs amounting to 1% of the gross national product. There is currently no effective disease-modifying treatment for OA, only symptomatic treatment at a late stage.

OA increases the risks of joint inflammation, pain, stiffness, swelling, disability, morbidity and mortality, and it reduces quality of life and work performance. OA might lead to reduced mobility and chronic disability and is associated with cardiovascular and metabolic co-morbidities. PLX-PAD is an innovative anti-inflammatory allogeneic placental cell therapy product candidate to treat patients with mild to moderate knee OA as a direct approach to reduce inflammation and cartilage degeneration.