Forum Topics RCE RCE Phase II ABSSSI trial dosing c

Pinned straw:

Added 11 months ago

RCE announced today that their Phase II trial in Australia of R327G for ABSSSI (topical skin and wound infections) had completed dosing with results due in Q1 CY25. Noting no Serious Adverse Events and positive outcomes pre official results. 

The market was expecting this information in December, so there may have been a delay, but Phase III trials of R327G are expected to start in H1 CY25 (assuming Data Safety Monitoring Board results for Phase II are ok, which we have been lead to believe is expected).

The Phase III trial of R327G in Indonesia was mentioned but a LinkedIn post shared by James Graham is more informative as it shows solid government support in Australia and Indonesia which is critical:

https://www.linkedin.com/posts/ajparker1_so-much-of-the-co-operation-between-australia-activity-7283491545801007105-5mnW?utm_source=share&utm_medium=member_desktop

Disc: I own RL+SM

lastever
Added 11 months ago

@Tom73 Thanks for posting about Recce. The results so far seem promising. I've been hearing about a lack of effective new anti-microbials since forever. The Reece results on the skin treatment seem consistently good, and if sepsis also follows then surely this will take off.

It seems taking the Indonesia route for a phase 3 threw a few investors, but it makes sense - it's no doubt less expensive and Indonesia really wants both an effective treatment for diabetic ulcers and to build up it's medical trial expertise. And if Recce treat 200 people there successfully plus whatever they do in Australia they'll have the funds for the US.

Like I said I'm no expert, but since the foot ulcer treatment appears to have positive results for pretty much everyone (who have been struggling with all other treatments), it seems logical that this will continue in phase 3.

My main question is what is happening with those people who see only partial foot ulcer recovery. What complications are causing that? Obviously all other treatments were failing, so partial is good. But if it's those appear to be about the most chronically ill, and people treated early with Recce mostly see a full recovery, then that would be very positive for the treatment.

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Tom73
Added 11 months ago

Cheers @lastever , results have looked good, efficacy results have been on small samples so far but the Gel (R327G) for topical application looks very promising and the unusual approach to do Phase 3 and commercialise in Indonesia at the same time as TGA Phase 3 for FDA (which will take twice as long) is a sign of their confidence. It may also accelerate the interest of a major pharma company if they can show in market effectiveness. We should get some initial results around mid-way through Phase 3 that I hope will provided more clarity on degree of effectiveness and any issues impacting efficacy.

It may also help support interest in the intravenous application (R327) which is further behind in the clinic. A pharma deal to help fund clinical trials and commercialise has to be high up on their wish list, I can't see them taking any of their products to market - case in point is the partnership in Indonesia with PT Etana Biotechnologies to run the trials and I expect there are some commericalisation elements.

As you point out antibiotic resistance is a major issue from a health perspective. However it is also a problem with the business model for companies developing antibiotics/anti-infectives, because it's just not worth the cost to research and develop new antibiotics due to the short time in market they can be used before becoming ineffective. This is probably why Recce has had trouble getting interest from major pharma companies because the whole antibiotic area of medicine has been such a business disaster that no one is interested.

The game changer for R327 is that it appears to overcome resistance and that in-vitro (lab) testing shows that it doesn't build up over time, so if it is approved then it will have a long life in market and due to it's designations it has extended patents so will be covered for longer than most drugs.

So if it works and is approved, it will be a revolutionary health outcome and extraordinary commercial success. Something I am backing with our families hard earned cash.

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