Transcription of The Stock Network Interview with Patrys (ASX:PAB), CEO Dr Samantha South
Lel Smits: Patrys is advancing its lead drug candidate, RLS2202, towards its first clinical trial in humans. During the June quarter, Patrys appointed a specialist clinical trial site and contract research organisation, progressed its trial protocol and submitted its ethics application. The company is now targeting first participant dosing in the third quarter of this year, subject to the required approvals.
I’m joined today by Patrys CEO, Dr Samantha South, to discuss RLS2202, the company’s path into the clinic and what investors can expect next. Sam, welcome to the Stock Network.
Samantha South: Thank you so much.
Lel Smits: Now, you’ve made several very important steps towards starting the Phase 1a trial. What does the company need to complete now before the first participant can be dosed?
Samantha South: Yeah, so I was just hoping that I could make mention of the fact that this, although this is the first time that an IV formulation of catiopine has ever been administered to humans, it’s not the first time that a human has been exposed to catiopine. So this study is definitely intended to assess whether there are any additional safety concerns with the injectable formulation of catiopine and establish the IV doses that we’re going to take forward for efficacy assessment.
But to do this, we do need to perform several de-risking steps before we can start. We’re still pending ethics approval. So as part of a standard ethics approval process, Patrys has been asked to provide some additional information.
This is quite normal, quite standard. And especially for early-phase clinical trials, the way that Patrys is completing. And so we’ll update the market on the outcome of the ethics approval as soon as we possibly can.
Once the ethics approval is obtained, we can then submit to the TGA for trial approval, which is a notification process with the TGA. And then we can finalise our site and start recruiting participants. So we’re very excited about that.
Lel Smits: So for investors who may not be familiar with RLS2202, what problem is Patrys trying to solve? And also, what do you think could make this injectable treatment different to what else is out there?
Samantha South: The delirium affects up to 80% of ICU patients. It costs the Australian healthcare system about $9 billion and the US healthcare system about $164 billion annually. This occurs through increased ICU stays, hospital stays, more mechanical ventilation time and higher complication rates.
And it can also lead to a long-term cognitive decline. So it improves the opportunity for you to actually end up with dementia. So despite this huge burden, there’s very little treatment options for delirium.
And clinicians usually rely on off-label oral catiopine or other antipsychotics or sedatives. However, many of these patients are intubated or otherwise unable to swallow pills. And oral dosing, especially of catiopine, can be slow.
It’s unpredictable. And it’s often really impractical because basically it’s really hard to provide oral dosing to patients in the hospital setting. And especially when you might need rapid symptom control.
For example, if you have agitated delirium. So what we’ve done is we’ve taken the fact that oral catiopine is actually working and the clinicians really like it, but we’ve reformulated it into an intravenous version of catiopine. And RLS2202 is the formulation that we’ve designed.
It was really hard to actually come up with because solubility of catiopine is not very good. And so we’ve formed it into an injectable form that’s specifically used for acute care. And this can provide faster, more predictable onset than oral dosing, a practical option for patients who just can’t swallow.
And it potentially can shorten ICU stays and improve the safety for both patients and staff. Because it’s a reformulation and not a new molecule, it’s been developed using the FDA’s 505B2 pathway or the EMA’s hybrid pathway, which means that we can leverage all of catiopine’s existing data from the oral drug. And then use that for, it means that we don’t need to use, perform a whole new preclinical or clinical package.
We can leverage all the data that we already have. And this is a strategy that’s been supported in million-dollar acquisitions from similar hospital reformulation products, including a formant, which was a product for a paracetamol, taking oral paracetamol and turning it into IV formulation.
Lel Smits: Excellent. And Sam, with the trial infrastructure now in place and also funding secured, what do you think those key milestones are that investors should be watching?
Samantha South: Yeah. So Patrys’s near-term focus is absolutely on getting RLS2202 into humans. So our key milestones definitely include securing the ethics and the governance approvals with the sites and completing our TGA notification under the CTN scheme in Australia.
We can then complete recruitment for the phase 1A bridging study volunteer. And we actually have two different cohorts as part of our study. So we’ll complete cohort one and we can set up cohort two.
And then we can finalise the GMP manufacturing at Biocena for cohort two. FDA regulatory engagement early is really key for us. So we’re definitely targeting finishing the phase 1A participant dosing by the end of this year, and then being ready to submit our FDA pre-IND submission in early 2027, and making sure that the regulatory bodies are absolutely on board with what we’re planning to do for the rest of our clinical development.
Lel Smits: Sam, thank you for the update from Patrys.
Samantha South: Thank you. Thank you for your time.
Ends