- Paradigm Biopharmaceuticals (PAR) has presented the market with an end of year update
- The company will meet with the U.S. FDA in February and provide feedback on its phase 3 clinical program
- Paradigm has also added people to its team to prepare for the big year ahead
- The company expects to update the market on its SAS program for osteoarthritis program in the second quarter of 2020
- Paradigm is down 8.63 per cent on the market today and is trading at $2.86 per share
Paradigm Biopharmaceuticals (PAR) has presented the market with an end of year update.
Osteoarthritis (OA) is the most common joint disorder in the United States.
Symptomatic knee OA occurs in 10 per cent of men and 13 per cent of women aged 60 years or older. This number is expected to increase due to the global aging population and the obesity epidemic.
Last month, the company met with Therapeutic Goods Administration (TGA) to present the provisional approval of Zilosul, for the treatment of knee OA.
At this meeting, TGA provided valuable guidance and based on this information Paradigm is proceeding with the provisional determination assessment process.
Zilosul is an injectable PPS not currently registered in Australia. However, th injectable is available in four of the seven top global pharmaceutical companies.
The company will meet with the U.S. FDA in February 2020 for a pre-investigational new drug application (IND). The application is for its OA program which treats knee pain in patients with subchondral Bone Marrow Lesions (BMLs).
This meeting will also provide feedback on Paradigm’s phase 3 clinical program to support regulatory approval.
Paradigm is preparing for a scientific advice application to discuss its knee OA development program in the first quarter of 2020.
This will provide clarification on the clinical trial running to support regulatory approvals for Europe.
The company is also preparing for a combined U.S., FDA, and EMA joint parallel advice application to discuss the MPS phase 2/3 clinical trial for the start of next year.
Paradigm has also had a few key appointments to the team.
Donna Skerrett has joined the group as its Cheif Medical Officer based in New York. She has extensive experience with U.S. FDA IND’s.
Next year, Mitch Marrow and Simon White will join its investor relations team in U.S. and Australia. Both have extensive experience in the financial industry and are high-profile retired sports stars.
The company expects to update the market on its SAS program for the 400 knee OA patients in the second quarter of 2020.
Paradigm will also start the expanded access program on ten knee OA with BML patients, in the new year.
Paradigm is down 8.63 per cent on the market today and is trading at $2.86 per share at 12:24 pm AEDT.