The US Food and Drug Administration (FDA) has extended the clinical hold on Ortho Regenerative Technologies’ investigational new drug (IND) application to commence a Phase I/II clinical trial of ORTHO-R in rotator cuff tear repair.
A Chitosan-Platelet-Rich Plasma (PRP) hybrid drug/biologic implant combination product, ORTHO-R is formulated and made to enhance the healing rates of occupational and sports-related damages to tendons, meniscus and ligaments.
It is used as an adjunct to standard of care surgical procedures in rotator cuff tear repair.
During a routine surgery, ORTHO-R can be directly delivered into the injury site by a surgeon without increasing operative procedure time and additional intervention.
In the initial clinical hold letter issued in June 2021, the FDA sought additional Chemistry, Manufacturing, and Control (CMC) related data.
The FDA has now accepted the three most complex supplemental data on characterisation at point of care and CMC, submitted by the company in response to the initial letter.
But the agency has sought additional clarifications on two advanced approaches of impurity characterisation, including further planned testing method.
Ortho Regenerative Technologies president and CEO Claude LeDuc said: “We are pleased to see that the FDA has accepted the recently submitted sterility and endotoxin level testing on the autologous PRP/ORTHO-R preparation workflow, as well as the identification of the drug substance following reconstitution in water, rather than in PRP.
“We are already working with our CMC experts, on the new CMC clarifications requested by the FDA. They relate to advanced methods of characterisation used in the CMC processes, to assess impurities.”
Clinical aspects to initiate the trial are all good, the company added.
The prospective, randomised, controlled and blinded Phase I/II trial intends to assess the safety and efficacy of ORTHO-R along with standard of care (SoC) surgery compared with SoC alone in rotator cuff tear repair.
It will enrol a total of 78 subjects at ten clinical centres in the US in the coming months.