The trial of knee osteoarthritis participants Phase 2b clinical trials has been fully recruited, it is expected to report results before the end of this year.
Mr. Paradigms CEO Paul Rennie said that rapid recruitment showed a strong demand for new treatment “breakthrough” treatment of knee osteoarthritis pain.
Rennie says: “The clinical and paradigm regulatory teams, as well as all the clinical trial recruitment and treatment centers have done an extraordinary job to complete the recruitment of this phase 2 clinical trial in just over seven months.”
“The additional emphasis on outstanding work is the second phase of the Paradigm 2a clinical trial (Rose River Virus) that is also nearing completion.”
Positive reports from patients stimulate the progress of treatment
Mr. Rennie said Anglicans of amylase sulfate injection of poly (IPPS) could become the treatment of osteoarthritis, “breakthrough”, because current therapies do not provide enough pain relief or to provide any protection for the degradation of the structure of the joint, and also with The important side is related to the effect.
He said that the media treated patients under the TGA Special Access Program has been a strong report, to promote the recruitment of the test, doctors and the public treatment of patients’ referral.
The main results of the test are knee pain evaluation of IPPS impact of knee osteoarthritis cartilage and bone lesions (BMLS) patient evaluation Knee injury and osteoarthritis Score results (the KOOS) pain subscribe.Secondary outcomes included changes in the KOOS joint symptom score in the knee joint and changes in MRI in the BML volume.
The FDA can quickly track this treatment
Osteoarthritis is a significant medical needs not met in the disease, the market size of $ 5 billion per year, low cost, generic treatment accounted for most of the total.
If an effective new treatment for patent commercialization, especially when IPPs that opiates or steroids, can significantly increase the size of the market, so it is not addictive.
Mr. Rennie said that as the attention of the opioid epidemic, Paradigms believes that it is likely that IPPs will quickly specify the US Food and Drug Administration (FDA).
Osteoarthritis (OA) is the most common form of joint disease worldwide and affects 13% of the world’s population.
In the United States, the financial burden of OA is estimated at $ 81 billion in medical costs and total costs amount to $ 128 billion, due to some 21 million people suffering from restrictions related to OA, and 36 million of outpatient consultations and 750,000 hospitalizations every year. Year.
3 million people in Australia
In Australia, OA affects approximately 3 million people, which represents approximately 15% of the population. OA is the leading cause of pain and disability in Australian elderly and the third leading cause of loss of life due to disability.
Australia each year about 19,000 cases of hip replacement and 25,000 cases of knee arthroscopy for the treatment of osteoarthritis, direct medical costs were more than $ 475 million and $ 500 million.
As the population ages and the obesity epidemic increases, the global prevalence of carbon monoxide will also increase with global growth. OA most commonly affects large joints that support weight, affecting 37% of the knee joints in more than 60% of adults.
Pain is the main symptom of patients with OA, and 17% of American adults aged 45 and older report that pain is a major clinical problem.
Test in six locations in Australia
Phase 2b trial will be double-blind, placebo-controlled, and at six locations in Queensland, Victoria, South Australia and Western Australia.
So far, according to the special TGA admission programs, pain 75 patients reported an average duration reduced by 50%, so far a total of more than 370 patients with OA were treated.
Paradigm is expected to report the results of the Phase 2b Critical Phase clinical trial at the end of the fourth quarter of the calendar year.