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Danrh

Thanks for the links . It's interesting that both the FDA and the EMA are quite happy to model a phase 3 trial on the basis of the efficacy of XF-73 vs current standard of care and the presentation from Prof Wilcox strongly confirmed the medical communities belief that S.aureus can be eradicated, if the pathogens can be successfully treated pre op and as we all know XF-73 is vastly superior in this respect to Mupirocin.

It's worthwhile to re visit the EMA advice for the modelling of the phase 3 trial:

· A simple, microbiological primary endpoint is acceptable for European approval of the XF-73 nasal gel. It will measure the percentage of patients demonstrating decolonisation to a level of eradication. This is consistent with the primary endpoint used in the very successful Phase 2b clinical study that reported outstanding results in 2021.

· Agreement that the patient population to enroll in the Phase 3 trials will be those who are nasal carriers of S. aureus (approximately a third of all patients) undergoing surgeries that put them at risk of a post-surgical S. aureus or MRSA infection. This is consistent with the patient population enrolled in the successful Phase 2b.

· It has been agreed that in Europe XF-73 Nasal gel would be compared to a "standard of care" mupirocin treatment in the Phase 3 programme; mupirocin is the old dermal antibiotic widely used across the world for nasal decolonisation.

· Agreement with the proposed XF-73 Nasal gel product pack approach for Phase 3 and its commercial suitability for the European market.

Incidentally in the clinical trial data that you linked, I noted that number 7 in the "Outcome Measures" also showed 0 for the Measure type - Number/unit of measure events. Yet my understanding that XF-73 passed this control with flying colours ?

Without wishing to sound patronising, that's the sort of debate one likes to see on a bb. Your views are not de ramping in my view, but just providing food for thought. I like to uncover every stone to see what's lurking underneath.

My understanding is that there has been a major study in the US involving some 300,000 patients, evaluating the efficacy of Mupirocin against the antiseptic iodofor in the elimination of Staphylococcus aureus in the nasal cavity prior to surgery. It is recognised that S.aureus is the primary infection causing pathogen in surgery. The main conclusion of the study was that Mupirocin was superior in reducing S.aureus nasal cultures vs iodofor.

We should all be aware of the performance of XF-73 vs Mupirocin, with a 99.9% reduction of nasal colonisation of S.aureus in a clinical setting with additional important benefits over the current standard of care as shown at 1hr 33mins 22secs in this presentation :

https://www.youtube.com/watch?v=c7CQ6qPXvBI

I fully understand the need for a larger cohort to be studied in a phase 3 trial and the parameters of this trial have been agreed in consultation with the FDA. So, I fail to see where your claim " that clinical proof of concept is still to be demonstrated for XF-73." comes into play. Mupirocin is the current standard of care and XF-73 has been shown to be the superior product. Perhaps you could enlarge upon your thoughts on this point.

As an important aside, lets keep the board civil. Insults say more about the person using them than the poster to whom they are directed.

But surely Van 2000 the appeal of XF-73 to large pharma is that should it fulfil its potential, and thus far the portents are excellent, then it would become the standard of care for operations worldwide. I don't know how many millions of procedures are carried out each and every year but surely this would make XF-73 attractive to any global pharma. Little but often, so to speak.

On your second point it is clear that Destiny fell short on the business side of things. Mid year steps were taken to address this problem, with the appointment of Susan Koppy, the re appointment of Sir Nigel Rudd and the replacement of the ex CEO with Chris Tovey. I've every confidence in the new team and it was the reason I bought in.

I have any problem with the Company diversifying and the purchase of M3 gave us another string to our bow. It's planned to move into phase 3 trials next year and I'd rather have it in the portfolio, than not.

I personally do not believe anyone will put in an offer for Destiny before the results of the XF-73 phase 3 trials are known, but never say never.

After all AstraZenica recently acquired Icosavac for up to $1.1 billion, based upon the successful phase 2 trial results of their IVX -A12 vaccine.

It's phase 3 ready so in many ways, not dissimilar to our own situation .

Given the above and the strength of our science, my only surprise is that Destiny appears to be still under the radar of many investors.

Admirable though it is, I don't know how the Royal Navy got involved :) hic !

And in the admiral spirit of not persuading people to blindly follow those that are over bullish on these boards (not just here) perhaps you could help them by explaining the risks as you see them for Destiny.

Who knows, it might even be the catalyst for a sensible debate. Cards on the table time :)

There was a trading update last year on 22nd December and the share price went up over 50%.

Does lightning really strike twice :)

Different vehicles.

Whilst considering downsides, I don't believe we should lose sight of the drag on the current share price as a result of a constant seller, operating since around July of this year.

Speculative I know, but I believe it's the Wade Furniture Group who have been off loading their 1,250,000 shares. I regard them as a distressed friendly seller, if it is them, and certainly explains the orderly nature of proceedings.

Their last accounts for the period ended 2nd October 2022, published in March, were showing a loss of £1.5 million, so they certainly need the cash.

I tend to agree, otherwise if for any other major reason, why stay at the table.

Https://www.investegate.co.uk/announcement/rns/astrazeneca--azn/astrazeneca-to-acquire-icosavax-/7936021

I agree sajy and more particularly to invest circa £2 million into the product and its development.

In the Investor Meets presentation in October, Bill Love said that the funding from NIAID has allowed Destiny to undertake a large clinically enabled study of XF-73 dermal, which is ongoing, and they look forward to presenting the results at the end of this year. The study is being run by NIAID.

He goes on to give an overview of where we are at with XF-73 dermal and its efficacy vs the present standard of care.

From around 1 hr 42 mins 05 secs on the link:

https://www.youtube.com/watch?v=c7CQ6qPXvBI

On the face of it one would think that perhaps 15th December would be the deal or no deal date, being a year from the PSA announcement but even that doesn't hold water as the rns was released on 12th December last year.

The mind boggles.

I agree this mid price nonsense where a sale or buy is determined at which side of the line a trade falls is a farce.

We are in the 21st century after all.

At present buys are 68.395p and sells are around 68p but because of the above, everything is showing as a sell.

The system needs changing but unfortunately it suits the market to continue as is.

Sajy

Hope you don't mind but I thought folk might like a re fresher of those results that you mention.

It's good info for newbies as well:

https://www.destinypharma.com/2023/07/31/publication-of-new-data-for-xf-73/

Well that's very encouraging, particularly as I believe we might receive further news and updates :)

Buena - Cyber

Yes the reference to the paywall was the Telegraph, hence there was no point in posting the link as most will not presumably be subscribers.

And yes, I do appear to have mis read, that it only applies to applications for trials.

The UK Health Secretary has just announced plans to streamline the drug approval process in the UK and I post an excerpt below, with apologies, as it is behind a pay wall, so will not copy and paste with a link:

"Life-saving drug trials will get the green light more quickly under plans to take advantage of Brexit by cutting red tape.

Steve Barclay, the Health Secretary, will on Sunday announce a new fast-track process halving the time it takes for some research to get under way.

Regulators have cleared a backlog of more than 2,000 applications, which built up after a surge of interest in research in the aftermath of the pandemic.

Writing jointly with June Raine, the head of the Medicines and Healthcare products Regulatory Agency (MHRA), Mr Barclay pledged to streamline research processes further as part of the biggest reform of clinical trials for more than 20 years.

The changes have come about because regulators have more freedom to design their own processes, including identifying trials that can be authorised more quickly.

Although applications should be assessed within 30 days, the average wait hit four months earlier this year following a surge of applications. In an average year, the MHRA normally approves around 750 new trials per year. Since July, it has approved 2,200, wiping out a backlog of almost 1,000.

Steve Barclay has pledged to streamline research processes further

Steve Barclay has pledged to streamline research processes further CREDIT: Paul Grover for the Telegraph

On Sunday, Mr Barclay and Ms Raine will set out plans meaning that approval time for low-risk trials will be reduced to 14 days. The changes apply to phase three and four trials, meaning safety risks have already been examined, and in cases where there are no known safety risks."

Bear with me because much of this is above my pay grade but given that XF-73 has an excellent safety profile and accordingly we were able to undertake a phase 2b trial aimed primarily on the efficacy of the treatment, which was passed with flying colours, I wonder if this new development would be of benefit to our phase 3 trial of XF-73.

I hesitate because the trials to date have been regulated by the FDA and I do not know if it's possible, if desirable, to run an alternative trial in parallel under the direction of the MHRA ?

The design of the phase 3 trial has already been approved by the FDA :

https://www.investegate.co.uk/announcement/rns/destiny-pharma--dest/xf-73-nasal-final-phase-3-development-plans/7321095

The phase 2b trial, once recruited, took 3 months for results, with a patient sample of 125. The increased cohort in phase 3 will clearly lengthen the time of the trial but we look to be an excellent fit for these new plans announced today.

I'd be interested in people's views.

Thanks for the clarification, which I believe was necessary as the two companies are operating in completely different fields of medicine.

OBD mainly operating in the area of screening tests for an assortment of conditions, evolving from their 3D genomics expertise.

However, I do note the recent success of their PSE prostate cancer test showing a 94% accuracy against 55% for the standard PSA test and OBD's over 4 fold share price increase on the release of this news, together with the launch of the test.

Thus, it's worth emphasising that XF-73's performance against the current standard of care in our market (Mupirocin) is even more impressive than the figures above, as detailed in the Company's recent Investor meets presentation.

In what way is the OBD platform similar to the Destiny platform.

In my view the XF-73 platform is unique.