Evgen Pharma Share Discussion Threads

[moneymunch] 24/3/2021 08:10

On and UP!!! Gla :-)

[bumpa33] 24/3/2021 08:06

V Good article that. And it appears to be doing the trick first thing, bids of 250k in two places, nothing on offer for now...

they need to keep this PR up, it’s a decent start though.

[moneymunch] 24/3/2021 06:46

Yep, it's the Procative Investors article already in the header. Gl ;-)

[muddy_40] 23/3/2021 20:32

I see also a bit of traction starting on twitter with the articles. Hopefully can make a difference

[on target] 23/3/2021 20:28

Cheers muddy, that is a better article :)

[muddy_40] 23/3/2021 19:30

Pushing the boat out now with publicity. Now the Daily mail. Hopefully bring interest. Good article..I like below bit

What comes through clearly from the foregoing – and a point spotted by the new investors joining the Evgen register – is the company is not some binary life-sciences one-trick pony.

Each area or drug indication for SFX-01 represents a value inflexion point that could deliver significant upfront and milestone payments as well as royalties on sales of a commercial product.

Analysts and investors refer to a company in this position as having multiple shots on goal – the idea being the more shots a life sciences business has the more likely it is to score a drug success.

[on target] 23/3/2021 12:00

Thanks for posting muddy. I wonder when that interview actually took place though as some of the info is not the latest, e.g. patient numbers, interim analysis, new CBO announced yesterday etc. It could easily have been written a month ago.

[muddy_40] 23/3/2021 11:35

Good interview with Huw

[ptolemy] 22/3/2021 11:59

OK thanks - I'll go and do more research..

[moneymunch] 22/3/2021 11:58

There's a 28 day assessment on each patient following the 14 days of dosing, that's why the DSMB were able to assess the first 60 patients recruited to the trial, and prelimanary efficacy data will be available for the first 100 during Q2...Gl ;-)

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

[on target] 22/3/2021 11:54

>If the trial last 28 days/per person it must be over for the first 100 recruits?

Yes, hence why they can do a preliminary assessment.

The STAR-COVID trial is for treatment of ARDS (Acute respiratory distress syndrome), either caused by COVID-19 or other causes.

[ptolemy] 22/3/2021 11:50

On Target,

I thought Sulforaphane is for treatment of chronic illness? (I've been taking it for nearly 10-years.) If the trial last 28 days/per person it must be over for the first 100 recruits?

[moneymunch] 22/3/2021 11:48

Ptolemy, Prof Chalmers will announce preliminary efficacy data from SFX-01's Covid/Ards patient trials, as highlighted by ontarget....Q2 is early as next month and positive data confirming or suggesting efficacy will be a game changer imho. We're now at a point where multiple news is expected from across the pipeline, hence my view that “newsflow is likely to come thick and fast from now on in” , starting with todays news of the appointment of a Chief Buisness Officer, and much more to expected in the coming days and weeks. Gl ;-)

[on target] 22/3/2021 11:23

"THEN at least a year of dosing" - no, dosing takes place over a 14 day period followed by another 14 days of assessment.

[on target] 22/3/2021 11:21

On the STAR trial see this RNS ptolemy:


"Following this positive step, the next event in the trial involves an assessment of safety and futility by the DMC of unblinded data on the first 100 patients treated. In addition to the DMC safety and futility assessment, Dundee University has decided to review the top-level unblinded data in a preliminary assessment of possible efficacy. This may lead to adjustments to the design of the trial for remaining patients, including in-patient numbers, and possibly early termination for either safety, futility or alternatively, strong efficacy. It is expected that this initial data will be available during Q2 of the calendar year 2021. "

So as well as the DMC safety and futility assessment we will be getting a preliminary assessment of efficacy.

[ptolemy] 22/3/2021 11:16

Moneymunch / Anyone

“newsflow is likely to come thick and fast from now on in”

May I ask what’s behind this view?

What EVG have said is:
“initial data will be available during the second quarter of calendar 2021”. That’s initial data for safety only. That’s like saying ‘the trial has shown water is safe to drink’

They’ve also said, “Completion of recruitment to the STAR trial is anticipated at the end of 2021 /Q1 2022, assuming there are no substantial changes in the total patients to be recruited.”

So, 9 more months of recruitment, THEN at least a year of dosing. Randomised controlled trials take a long time. In the interim we can't expect positive news (that can only come at the end of the trial). So, by default any interim news must be neutral/negative.

Any views why these ideas are wrong is welcomed.

[clocktower] 22/3/2021 09:26

A positive start is always a good omen early in Spring.

[bumpa33] 22/3/2021 08:12

(Stay) classy amaretto 🤦🏼‍♂️

[bumpa33] 22/3/2021 07:44

grovel harder.

[raldo] 22/3/2021 07:42

Morning all, sorry for thick question but how does the Guild coin work please? I asked Nobby for a coin a while back... do I need to do anything?! TIA.

[amaretto1] 22/3/2021 07:23

She's not being taken on for nothing ... that's for sure !