Paradigm Biopharmaceuticals Ltd (ASX:PAR) has executed an agreement with a US-based medical school for use of its injectable Pentosan Polysulfate Sodium (iPPS) in the treatment of mucopolysaccharidoses (MPS).
The exclusive in-licence agreement has been signed with the Icahn School of Medicine at Mount Sinai, New York, and covers use of iPPS for MPS, a group of inherited lysosomal storage disorders.
MPS is a rare inherited disease which causes debilitating joint pain and dysfunction and a key unmet medical need in this class of inherited disease is the lack of treatment.
The agreement includes Phase 2a safety and efficacy data which provides valuable long-term safety data on iPPS, which can be included in US FDA submissions for Paradigm’s OA/BMEL primary indication.
Synergies with OA/BMEL program
Paradigm said the licensing agreement and accompanying data was complementary and synergistic to the company’s OA/BMEL program.
As such, the company said it was a logical and valuable addition to the product pipeline and IP portfolio at this time.
The agreement was executed on attractive commercial terms, providing the company with highly valuable intellectual property (IP).
Based on Paradigm’s review of the human clinical data, the product development for the targeted population of people who have inherited the rare disease could receive ‘fast-track’ approval following a pivotal Phase 2b clinical trial.
The new IP will fall under the same terms of exclusivity and supply that Paradigm enjoys with bene pharmaChem.
This newly in-licensed indication is fully funded for the next 12 months and beyond.
Paradigm’s primary focus remains reading-out of the Phase 2b OA/BMEL clinical trial head-line results, and this is expected in mid to late December 2018.
Leader in medical research
The Icahn School of Medicine at Mount Sinai is a not-for-profit corporation, which is a leader in medical and scientific training and education, biomedical research and patient care.
Mount Sinai Health System is New York City’s largest integrated health delivery system encompassing seven hospital campuses, leading medical school, and vast network of ambulatory practices throughout the greater New York region.
Paradigm is focused on repurposing Pentosan Polysulfate Sodium (PPS), an FDA approved drug that has a long track record of safely treating inflammation.