Evgen Pharma Share Discussion Threads

[peanut100] 05/1/2021 10:05

What I like is no cash required until near year end if they can announce some sort of milestone payment before then none will be required so no dilution for holders. Cash runway extends into Q4 2021. Evgen has sufficient cash to complete CMCand additional toxicology studies for SFX-01, providing a runway into at least late Q42021 and for the company to deliver on a value-enhancing milestones.

[moneymunch] 05/1/2021 07:04

PAT is flying , MTFB next ....who was slagging me off??? Gla ;-)

[amaretto1] 04/1/2021 16:53

I've been adding today ...Only 50 k In 3 lots

[on target] 04/1/2021 12:35

Very limited time given to speak, so perhaps just picked the one that was most advanced to mention.

[timbo003] 04/1/2021 11:46

You can hear last night's 5 live interview(s) here



Starts at around 15:00

[on target] 04/1/2021 11:19

Wonder why he didn't mention SFX01/sulforaphane?
Does he need a kick up the backside or what??

[nobbygnome] 04/1/2021 10:55

I have bought more this morning. I just can't understand why the herd haven't caught up with the ridiculous undervaluation here.

I actually heard the interview on 5Live last night and he didn't mention sulforaphane. The only mention was the Brensocatib trial which he said would be out in February.

[moneymunch] 04/1/2021 09:13

The extremely powerful steroid Dexamethasone, which has been shown to reduce deaths , which many hoped would be an effective treatment for Covid-19 could actually be detrimental according to The Lancet. Gla ;-)

.........

Their pertinent analysis is based on the background of the RECOVERY trial, which concluded that therapy with dexamethasone at a dose of 6 mg once daily for up to 10 days decreased 28-day mortality in patients with COVID-19 on respiratory support.

Patients not requiring oxygen showed no benefit but had a possibility of harm with corticosteroid therapy.

One crucial feature of corticosteroid therapy is its duration, particularly in patients with COVID-19 with sustained persistence of ground-glass opacities. Currently, an extended course of corticosteroids beyond 10 days is considered only in select cases of severe COVID-19.

One rationale for prolonged treatment is the prevention of post-disease fibrosis in patients with COVID-19 for whom risk factors for pulmonary fibrosis might be established.


However, in COVID-19, such a long-lasting course of corticosteroids can inadvertently lead to poor treatment outcomes.

...........

There is no evidence supporting long-term use of steroids in patients with COVID-19 to prevent potential adverse sequelae such as pulmonary fibrosis.

On the contrary, such an extended course of steroids could be detrimental.


htTps ://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30530-0/fulltext

[moneymunch] 04/1/2021 09:01

James D Chalmers
@ProfJDChalmers
·
5m

There is a common misconception that the roll out of vaccines means treatments for #COVID are no longer needed. This is wrong. #COVID is now an endemic human infection and cases will continue even once vaccines fully rolled out(which will take time) Need vaccines AND treatments

James D Chalmers
@ProfJDChalmers
·
5m

Thanks to @bbcfivelive for giving me the opportunity last night to talk about #COVID19 and the ongoing need for research into treatments. Dexamethasone still the only medication shown to reduce deaths. Urgent need to find treatments including for long-covid. @NIHRresearch

[moneymunch] 03/1/2021 17:53

No shortage of patients for SFX-01's patient trials, one would assume. Gla ;-)

James D Chalmers

@ProfJDChalmers

·

1h

Taking account of approx 5 days incubation period from infection and 7-10 days to develop pulmonary complications, the effects of Christmas mixing may be felt towards the end of the coming week in hospitals across Scotland. I hope i am wrong but it feels like a storm is coming

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James D Chalmers

@ProfJDChalmers

·

1h

2000 cases per day now in Scotland despite lockdown measures since boxing day. We know that this translates into a spike in hospital/ICU admissions in 7-10 days. COVID is a biphasic illness: mild symptoms initially, then lung involvement 7-10 days later in those at high risk.

[moneymunch] 31/12/2020 08:59

Yep, the ending wasn't too great Bumpa, but we're more than familiar with boom and bust cycles where every recession generally provides endless opportunities before the subsequent boom that normally follows, and so let's hope we can put this pandemic behind us with the planned mass vaccination and testing, so that any serious global downturn will be short lived and we can all look forward to better times ahead and get back to the way we want to live our lives.....Gl ;-)

ps A very Happy and Prosperous New Year to all and fingers crossed that Evgen delivers BIG this coming year........Every chance and more imho!!! ;-)))

[sideshowbull] 30/12/2020 19:40

Think it needs to be "rip roaring 2021"

BWTDIK

[bumpa33] 30/12/2020 19:30

I like your roaring twenties analogy mm. Let’s hope they’re right. Albeit without the ending.

[moneymunch] 30/12/2020 15:57

Let's hope SFX-01's patient recruitment is in full swing. Gla ;-)


James D Chalmers
@ProfJDChalmers
·
1h

From next week the vaccine roll-out will start to help.

But TODAY cases of COVID-19 in Scotlands hospital are still rising and many are becoming seriously ill.

Please, please stay home tomorrow night and have a quiet New Years Eve with your household.

Yours

everyone in the NHS

................

Lesley-Anne Kelly
@L_A_Kelly

· 1h

Another day, another new y-axis...

Over 2000 new cases. ( Scotland )

People in hospital still on the rise.

Positivity rate still too bloody high.

And sadly a death in the 20-24 age range from Boxing Day.

Please stay at home if you can.

[moneymunch] 30/12/2020 10:35

All very likely Bumpa and no doubt very painful and miserable for many this coming year, although a tad too much doom and gloom for my optimistic rose tinted glasses, with a few commentators predicting a similar scenario to the roaring twenties following the aftermath of WW1 and the spanish flu , where pent up demand for all the things you couldn't have or couldn't do, led to a decade of economic growth and widespread prosperity, and so it would be nice to think that when this pandemic is finally behind us, and we're all let off the leash, the World economies will bounce big. Gl ;-)

[moneymunch] 30/12/2020 08:36

James D Chalmers
@ProfJDChalmers
·
12m

There is a serious risk this gets lost in the news about the Oxford/AZ vaccine today but Independent Sage is likely to call for full national lockdown today in view of rising cases and serious pressure on hospitals.

The vaccine is for tomorrow. We need to control the virus today

Quote Tweet
Independent SAGE
@IndependentSage

· 14h

NEW: Independent SAGE has prepared an emergency statement & plan & is hosting a press conference tomorrow, 10am. Please join us. We believe we are at the most critical moment of the crisis so far. Only by acting NOW can we avoid 10s of 1000s of deaths

[bumpa33] 29/12/2020 09:57

As we have seen over the last few weeks, Cv-19 is an extremely fluid situation, in so many ways - as if we didn’t already know. Surely then trying to pin down timings as to patient recruitment, trial updates etc etc is fruitless. Could we be at 100 patients already? Sure. Could we still be some way off? Sure. Will there be early reports? I think so based on other cases, but who knows.

Endless speculation seems pointless, we’ll get news/updates/etc when it’s ready. You either think this is too cheap by any metric, buy in and wait, or you leave it alone.

The bickering is tiring though...

[bocker01] 29/12/2020 09:38

Nice one Nobby!

Well I missed Money's post Timbo so I was not provoked! Timbo, you might be right. The trial may run to June with one site operating. And then run the risk of a severe curtailment of patients. Bit like a centre-forward deliberately missing an open goal. Happens... but not often. Alternatively the timings given so far may turn out, naturally, to be prudent because there was obvious uncertainty about patient availability and up take.

No I am not implying that the company is misleading investors over the timings of the trial. That was unnecessary. As I am sure you are aware, when things change, a company issues revised guidance. It is rather dogmatic to assume that no adaptions to circumstances ever occur. Here we have a change to circumstances though - the second wave. So its a big change. That's important.

Also Timbo you also seem to be assume that it is the company that decides timings as opposed to its partners hence your comment re misleading. You may have seen the agreements between them but I have not so I assume unless informed to the contrary that it is either the partners or a collaborative who decide on the pace with the company supply the treatment. I suspect the partners will be chomping at the bit with the the unpredicted surge in pneumonia cases.

Finally you accept that the means to recruit much faster you just assume that they only use one site for most of the period. So I withdraw my comments about incorrect extrapolation in a pure math sense. It's all to do with whether they just recruit from one of the 10 sites and forget the other 9 for most of the trial. That's simply a guess on your part with no solid basis which may be bizarrely correct but seems to defy logic and common sense to me. Especially in current circs, I think they will be working hard to get this done fast and we will receive updates when it is appropriate.

Just as a passing point, this trial is getting a lot of focus but I am equally or more excited by the 5 or so items in the rest of the pipeline.

[nobbygnome] 29/12/2020 09:25

Just to say I put my money where my mouth is and have bought another 25k this morning!

[moneymunch] 29/12/2020 08:26

Wow....i rest my case. Gl ;-)

[timbo003] 29/12/2020 08:19

Post #6239 addressed to boker deliberately provocative, hence moderated

If it was not intended to be provocative, it would serve its purpose through a private message

[moneymunch] 29/12/2020 07:44

Yes indeed timbo, my mistake, all patients initially have to hospitalised with symptoms of Ards and pneumonia , regardless of testing positive, but unlike your dubious suggestion that the trial will only be conducted at one site or maybe two....ha ha ha ha....is clearly not the case according to the following trial protocol which also confirms 10 trial sites.

Gla Holders....the perfect storm for the surge in Covid numbers combined with the expected surge in winter respiratory illnesses , presents the perfect storm for SFX-01's potential.....early assessment will be made by the DSBM on the first 100 patients recruited and so every chance that number will be recruited very soon, given the current surge in numbers and Prof Chalmers rapid recruitment for his Stop-Covid trial....a positive asseessment and the green light for the trial to continue to Top Line results, expected Q4 2021 will be massive news for Evgen......plenty of UPside in anticipation and plenty of other potential news from the rest of the pipeline which could add significant value..... On and UP!!!! ;-)



Exploratory objectives (All sites)

Biofire analysis of nasal swab or sputum sample

Subanalysis of outcomes according to the causative pathogen

.....

Exploratory objectives (TAYSIDE ONLY)

Analysis of Nrf2 pathway activity in isolated peripheral blood mononuclear cells

Neutrophil functional studies in isolated cells

Measurement of interleukin-6, interleukin-1 beta and TNF-alpha in blood



...............................

........................


Background to the Trial 1

STAR-COVID 19 TRIAL

TRAINING BACKGROUND AND OVERVIEW

Community-acquired pneumonia is a leading cause of morbidity and mortality in the UK

There have been no new therapies for managing pneumonia since advent of antibiotics in 1950s

The global pandemic caused by novel coronavirus SARS-CoV-2, has highlighted the need for new drugs to treat pneumonia

Development of anti-inflammatory therapies that prevent late stage complications is needed

Such therapies are likely to be efficacious for a range of acute respiratory infections, including COVID-19

Patients with pneumonia and suspectedCOVID-19 are eligible for this trial. Patients do not require a positive COVID-19 test to be eligible

....................

Background to the Trial 2


The nuclear factor-erythroid 2 p45-related factor 2 (Nrf2) is part of the human natural defence against inflammatory and oxidative stress such as the inflammation that occurs during a severe viral infection

In animal studies, pharmacological activation of Nrf2 reduces the severity of acute respiratory distress syndrome (ARDS)

SFX-01(stabilised sulforaphane), a drug developed by EvgenPharma, is an activator of Nrf2

SFX-01 has been tested in over 130 subjects in clinical trials and is well tolerated with main side effects being GI related and ameliorated by taking after food

In this study one 300mg capsule of SFX-01 is taken orally per day for 14 days

This is the first study of the effect of SFX-01 in humans with acute respiratory infections at risk of developing ARDS

.......................

The trial will test the following hypothesis:

Treatment with SFX-01 in addition to standard care will be superior to placebo plus
standard care in achieving improved clinical status in patients initially hospitalized with community acquired pneumonia (including patients investigated for suspected COVID19 infection).

.........................

Primary objective:

To evaluate the clinical efficacy of SFX-01 compared to placebo on top of standard care in adult patients initially hospitalized with community acquired pneumonia.Outcome measure:7 point ordinal scale measured on Day 15.

Secondary Objectives:

Evaluate the clinical efficacy of SFX-01 relative to standard care in adult patients hospitalized with suspected COVID-19

Evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm

Outcome measures:

Cumulative incidence of serious Adverse events (SAEs)

Discontinuation or temporary suspension of treatment

..............................

Exploratory objectives (All sites)

Biofire analysis of nasal swab or sputum sample

Subanalysis of outcomes according to the causative pathogen

Exploratory objectives (TAYSIDE ONLY)

Analysis of Nrf2 pathway activity in isolated peripheral blood mononuclear cells

Neutrophil functional studies in isolated cells

Measurement of interleukin-6, interleukin-1 beta and TNF-alpha in blood