Proactive Investors - Run By Investors For Investors

Paradigm Biopharmaceuticals signs agreement for use of iPPS in treatment of MPS

An exclusive licence agreement has been executed with the Icahn School of Medicine at Mount Sinai, New York.
Image of human body with pain pressure points
Paradigm’s primary focus is developing injectable Pentosan Polysulfate Sodium (iPPS)

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.

READ: Paradigm Biopharmaceuticals enters agreement to treat US-based sportspeople

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.

READ: Paradigm Biopharmaceuticals boosts financial position with $2.32 million R&D tax rebate

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.

READ: Paradigm Biopharmaceuticals secures $9 million to accelerate phase III

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.

View full PAR profile View Profile

Paradigm Biopharmaceuticals Ltd Timeline

Related Articles

Empty lab
September 19 2018
Management has made some tough decisions, cutting the cost base, since a disappointing first-half performance and expects the benefits to really kick in next year
technician's in a lab clean-room
March 12 2019
The Maryland company is seeing revenue surge through an expansion of contract manufacturing services, particularly in the area of CAR T-cell therapies
genedrive device
July 16 2019
Here we take a closer look at Genedrive PLC (LON:GDR)

© Proactive Investors 2019

Proactive Investors Australia PTY LTD ACN:132787654 ABN:19132787654.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use