Positive Phase 2B Clinical Trial Results For iPPS Boost Paradigm’s Shares

  • Dec 18, 2018 AEDT
  • Team Kalkine
Positive Phase 2B Clinical Trial Results For iPPS Boost Paradigm’s Shares

The Australian biopharmaceutical company, Paradigm Biopharmaceuticals’ (ASX: PAR) shares went up by 12.5 percent today (i.e., 18 December 2018) after the company announced positive results from its phase 2B clinical trial of injectable pentosan polysulfate sodium (iPPS) in Knee Osteoarthritis pain.

Osteoarthritis is currently a leading cause of disability for people greater than 65 years of age, and it is the last frontier of blockbuster diseases with no treatment.  Paradigm’s 2B clinical trial was conducted across six sites in Australia with the aim of evaluating the effects of iPPS on knee pain in subjects with knee osteoarthritis and subchondral bone marrow edema lesions (BMELs).

As per the results, the Clinical trial has met the primary endpoint with a change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) from baseline at Day 53. The outcomes of the trials have confirmed that iPPS (ZILUSOL®) is having the potential of being a safe and effective treatment of knee osteoarthritis pain.  The company reported that 46.2 percent of subjects receiving iPPS demonstrated more than 50 percent reduction in pain from baseline as compared to 22.5 percent of subjects receiving Placebo under KOOS pain subscale in the NRS Pain = 4-6 strata. The key outcome from the trial is that clinically meaningful and statistically significant results between Placebo and iPPS were demonstrated across the total subject population and highly clinically meaningful and highly statistically significant results were demonstrated in the NRS pain = 4-6 stratum.

According to Paradigm’s CEO, Mr.  Paul Rennie, to achieve clinically meaningful and statistically significant results between Placebo and iPPS, is truly an outstandingly positive trial outcome.

As a result of Paradigm's Phase 2b results, the company is planning to file a New Drug Application (NDA) with USA FDA for a pivotal Phase 3 in Calendar year 2019. It is expected that the outstanding Phase 2b results will reach the higher effect and statistical significance in larger Phase 3 clinical trial.

Now after the release of positive results from phase 2B clinical trial, the company is well positioned to execute many valuable milestones throughout 2019 which include the filing of Investigational New Drug (IND) application for Phase 3 trial in OA/BMEL with the possibility of being granted “fast track status” for the Phase 3 trial. The company is also planning to release Ross River Phase 2a trial results in the first quarter of the calendar year 2019. Further, there is a possibility of earning revenue in 2019 through receiving ‘Provisional Approval’ from TGA to sell Zilosul (iPPS).

In the last six months, the share price of the company increased by 78.38 percent as on 13 December 2018. PAR’s shares traded at $1.485 with a market capitalization of circa $184.55 million as on 18 December 2018 (AEST 2:43 PM).


Disclaimer

This website is a service of Kalkine Media Pty. Ltd. A.C.N. 629 651 672. The website has been prepared for informational purposes only and is not intended to be used as a complete source of information on any particular company. Kalkine Media does not in any way endorse or recommend individuals, products or services that may be discussed on this site. Our publications are NOT a solicitation or recommendation to buy, sell or hold. We are neither licensed nor qualified to provide investment advice.

 

All pictures are copyright to their respective owner(s).Kalkinemedia.com does not claim ownership of any of the pictures displayed on this website unless stated otherwise. Some of the images used on this website are taken from the web and are believed to be in public domain. We have used reasonable efforts to accredit the source (public domain/CC0 status) to where it was found and indicated it below the image.

 

There is no investor left unperturbed with the ongoing trade conflicts between US-China and the devastating bushfire in Australia.

Are you wondering if the year 2020 might not have taken the right start? Dividend stocks could be the answer to that question.

As interest rates in Australia are already at record low levels, find out which dividend stocks are viewed as the most attractive investment opportunity in the current scenario in our report.

CLICK HERE FOR YOUR FREE REPORT!
   
x
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it. OK