Good news for Paradigm after its PPS/Zilosul product was successfully given Fast Track status by the FDA. This should help reduce the development timeline and ensure they can tick off FDA concerns as they go rather than waiting until it's too late/more expensive to do so.

[I hold a small parcel as a speccie/benefit to society play]

KEY HIGHLIGHTS

• Paradigm’s IND application to commence its phase 3 pivotal clinical trial investigating Pentosan Polysulphate Sodium (PPS) for the treatment of pain associated with knee osteoarthritis (the Trial) has been cleared by the US FDA.
• The US central ethics committee has already approved the Trial.
• Australian ethics approval for the Trial was previously announced on 24 September 2021.
• Approximately 65 sites have been identified throughout the US and Australia. Contracting with many of those sites has been completed. The first 4 sites in Australia have initiated screening participants. Screening at the US sites is expected to begin prior to the end of CY2021.
• The Company is now in a position to accelerate recruitment by adding approximately 10 sites in the United Kingdom (UK) and Europe, with site initiation and subject screening expected to commence in 1H CY 2022.

***

After a few false starts this is finally the news Paradigm was hoping for in 2021 (now to make sure it works). I'm generally not an investor in binary outcomes but Paradigm is a bit different. Firstly, they're using a treatment that has been widely cleared for use on humans for decades and their bet is on the injectable delivery of it (which opens up a whole lot of new applications - not least arthritis). Secondly injectable PPS has been used on animals for decades. You hear stories (and when they're on HC you generally apply a 90% discount rate) but I've seen it used on the Fonz (my dog) with remarkable results. Too good in some respects as after a year's treatment he hasn't needed another dose for about 5 years - not ideal from an investment perspective. On HC (discount 90%) people relate stories of having used some on themselves and the complete change in lifestyle that resulted. Here on SM, Chagsy told the story of one of his patients having access to it for his horse, using it on himself and getting similar results (not advised Chagsy was quick to point out). It's only a small part of my portfolio here and IRL but it's nice to be on a story like this once in a while.

The Fonz is pleased...

Paradigm Biopharmaceuticals Ltd (ASX: PAR) (Paradigm or the Company), wishes to inform the market it has received a written response from the US FDA in relation to its Investigation New Drug (IND) submission for pentosan polysulfate sodium (PPS) to treat pain in subjects with knee Osteoarthritis.

In response to the FDA's one request, Paradigm will make an amendment to Its protocol. Response received from the US FDA. The one outstanding question regarding adrenal gland function related to a preclinical finding in the adrenal gland of rats only and was not seen in the adrenal gland of dogs. Adrenal gland malfunction has not previously been seen by Paradigm or bene pharmaChem in their ongoing pharmacovigilance. This one preclinical finding has been the focus of the ongoing US FDA review.

Paradigm, working with external endocrinologists, presented changes to the clinical trial protocol, which included a comprehensive adrenal screening protocol and clinical monitoring as part of its mitigation plan. In the written communication, the FDA requested modifications to Paradigm’s adrenal screening and mitigation plan. Paradigm plans to amend its clinical trial protocol, including all the FDA’s requests, and respond to the FDA within the next week.

Paradigm assumes the FDA may again take 30 days to respond. Mr Paul Rennie, Paradigm Chief Executive Officer: “Although we understand the agency's obligations for thorough reviews which commenced in March of this year, I am confident that the FDA and Paradigm have now attained a pathway to commence our phase 3 clinical trial in the US”.

***

Another month and another month's delay.  At least the FDA didn't take the full 30 days to respond this time.  Hopefully this is it though and we'll get approval to proceed in October.  [Drums fingers on desk].

[Held]

Paradigm Biopharmaceuticals Ltd (ASX: PAR) (Paradigm or the Company), a clinical stage biopharmaceutical company focussed on repurposing existing molecules for new indications with unmet medical needs, is pleased to announce it has received Australian ethics approval for its pivotal Phase 3 clinical trial, PARA_OA_002, to evaluate the treatment effects of pentosan polysulfate sodium (PPS) against placebo on participants with Knee Osteoarthritis Pain.

***

Expect a pop in PAR today but this is really just an appertizer and no one awards Michelin stars on those.  We shouldn't have to wait long for the meat and three veg though, with FDA's response to their proposed Phase 3 clincial trial expected within a week (most likely right at the end of Sep).  It's been a slightly tortuous approval process over the past six months with the FDA seeking clarification on a number of undisclosed items multiple times.  Although way out of my wheelhouse I'm one of those investors that became interested in this company after seeing the transformative effect Cartrofen had on their pets and took a modest position partly based on their share registry and views of some that I follow.

[Relatively modest holding in SM and RL]