Ananda Pharma Plc (AQSE:ANA) finance director Jeremy Sturgess-Smith talked with Proactive about the company's progress with MRX1, a promising treatment for chemotherapy-induced peripheral neuropathy (CIPN) and endometriosis pain. Ananda has completed the final GMP-certified batch needed for regulatory approval, marking a significant milestone in its clinical journey.
Sturgess-Smith explained, "What we've done is we've now completed all the preparatory work before we can manufacture MRX1 to deliver to patients," emphasizing the upcoming trials in Edinburgh and Australia. The trials include CIPN and endometriosis studies at Edinburgh University, as well as a phase one pharmacokinetic (PK) study in Australia.
The next steps involve ethics submissions and discussions with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to ensure compliance with regulatory standards. Approval from independent ethics panels will ensure the clinical trials meet ethical standards, while stability data from these trials will support potential licensing with global regulators, including the FDA in the US and the EMA in Europe.
Proactive: Jeremy, very good to speak with you today. So you've announced a key milestone in the development of MRX1. You've completed the final batch needed for regulatory approval. So take us through that.
Jeremy Sturgess-Smith: Yes, thanks, Stephen. Good to be here. So this is a really key step for Ananda. Basically, what we've done is we've now completed all the preparatory work before we can manufacture MRX1 to deliver to patients, up in Edinburgh for our chemotherapy-induced peripheral neuropathy trial and our endometriosis trial, and also ship some down to Australia for our phase one pharmacokinetic study.
Proactive: Maybe take a step back and tell us what MRX1 is targeted at?
Jeremy Sturgess-Smith: Sure. So we've got, as I said, the two trials in Edinburgh, one focused on chemotherapy-induced peripheral neuropathy, CIPN for short. It's a very prevalent condition amongst those currently undergoing and having just undergone chemotherapy. Effectively, chemotherapy is a toxin, and when it enters the bloodstream, it can harm the nerves. The nerve pain is called chemotherapy-induced peripheral neuropathy.
It tends to be in the hands and feet and can be related to extreme pins and needles, burning sensations in the hands and feet. Up to 60% of CIPN patients will suffer from this up to three months following any chemotherapy treatment. Also, in partnership with Edinburgh University, we're running a trial into pain associated with endometriosis. Endometriosis is a condition where the lining of the womb grows outside of the womb in lesions and is extremely painful.
There's not really any current treatment plans for it. It is a condition as well that we believe is suffered by up to 10% of women globally. Also with MRX1, we're running what's called a pharmacokinetic study in Australia. A PK study is basically where we dose healthy volunteers with MRX1, and we track over a period of time how MRX1 enters the body, how it interacts with the body, and at what rate it leaves the body, so that we can understand what the dosing regimen should be when we go on to dosing patients.
Proactive: So now that you have that final batch, you're going to the MHRA before you go ahead with those trials. Is that correct, Jeremy?
Jeremy Sturgess-Smith: Yeah, that is correct. So next steps from here before we can pull the trigger, as it were, on the GMP-certified batch to be sent to the trials is run through ethics submissions, which are approvals run by independent panels to ensure that what we are planning to do is ethically acceptable. Those boards tend to be made up of independent health researchers, and we will also be in conversation with the MHRA to ensure that they are comfortable and they are happy that what we are doing meets the aims that they would like to see out in the study.
Proactive: And do you meet all the required standards for other healthcare regulators outside of the UK at this point?
Jeremy Sturgess-Smith: Yes. So the data that we will receive from the stability work that this technical batch will undergo will also be really critical following our clinical trials, for use in the approval process to gain a license to actually have this drug prescribed, both here in the UK with the MHRA, over in the US with the FDA, in Europe via the EMA, and globally as well. It will, of course, be used in Australia as well.
Proactive: So the next steps from here then, Jeremy?
Jeremy Sturgess-Smith: Go and have these conversations we need to have, make sure that the trial protocol is as tight as humanly possible. And then go and work with our manufacturing partners to deliver batches of drug into these clinical trials.
Proactive: Jeremy, I hope you'll keep us posted on any progress with that. Thank you very much for the updates.