মার্কিন যুক্তরাষ্ট্র জুড়ে হাঁটু অস্টিওআর্থারাইটিসের ক্লিনিকাল ট্রায়ালের নতুন পর্যায়

Paradigm Biopharmaceuticals is announcing today the official launch of their U.S. clinical trial program with an estimated 56 planned clinical trial locations nationwide for the conduct of the pivotal phase 3 trial to support registration of Pentosan Polysulfate Sodium (PPS) for osteoarthritis (OA) of the knee. 

Established in 2014, Paradigm Biopharmaceuticals has successfully identified, repurposed, and patented PPS, for the management of pain and inflammation, associated with musculoskeletal disorders including osteoarthritis (under the trademark Zilosul®) and the rare disease mucopolysaccharidosis. 

Paradigm is expanding its US operations to support the registration studies for the OA program. Simultaneously Paradigm is announcing activation of the phase 3 clinical trial network for Zilosul® to treat knee osteoarthritis. This is significant as osteoarthritis is the most common cause of disability among adults and affects more than 72 million people across the U.S., Canada, EU-5, and Australia.1,2

The purpose of this study is to measure the change in pain and function with subcutaneous injections of PPS compared with subcutaneous injections of placebo in participants with kOA pain. This is a 2-stage, adaptive, randomised, double-blind, placebo-controlled, multicenter (US/AUS/UK/EU) study that will evaluate the dose and treatment effect of PPS in participants with kOA pain.

Stage 1 comprises a phase 2b dose selection, with participants randomised receiving 1 of 3 PPS dose regimens or placebo for 6 weeks. The primary objective of stage 1 is to select the dose for use in stage 2, the selected dose will be based on an optimal balance of efficacy and safety.

Participants in stage 1 will be randomly allocated to receive:

•             1.5 mg/kg calculated for ideal body weight (IBW) PPS twice weekly

•             2 mg/kg IBW PPS once weekly + placebo once weekly

•             Fixed dose (100/150mg/180mg PPS ≤65/≥65 to ≤90/>90 kg IBW) once weekly + placebo once weekly

•             Placebo twice weekly

In stage 2, participants will be randomised 1:1 to receive the selected PPS dose regimen or placebo for 6 weeks.

The primary endpoint in the pivotal study is a change from baseline at Day 56 in WOMAC® pain with secondary outcomes including change from baseline at multiple time points out to day 168 in WOMAC® Pain and Function, Patient Global Impression of Change and Quality of Life.

“The activation of the phase 3 in knee OA clinical trial in the U.S. represents a significant step in Paradigm’s growth as a global leader in repurposing existing drugs.” Says Interim CEO, Dr. Donna Skerrett. “There is encouraging data indicating that PPS is not only an effective treatment in navigating pain management, but also for diseasing modifying potential, a significant medical breakthrough which does not exist for the treatment for osteoarthritis.”

Adopting an intelligent and agile approach to clinical R&D, Paradigm’s experienced team has built and sustained strong and successful collaborations with leading clinical researchers in the field. By repurposing FDA approved drugs, Paradigm aims to shorten the drug development cycle time for chosen applications and minimize development costs. Paradigm is working in concert with, and has exclusive supply agreements with, the proprietary and only FDA approved manufacturer of PPS, bene pharmaChem.3

Director of Investor Relations, Simon White, highlighted that this “approach to market helps Paradigm scale costs in drug development and apply additional focus and resources on globally harmonizing the drug application, and clinical program which aims to cumulatively expedite Zilosul’s introduction to the U.S. and other global markets.”