Genflow Biosciences Share Discussion Threads

[moneymunch] 06/4/2024 18:37

Great find Northeast and exciting news for Genflow. Gl :-)


First in human proof-of-concept Phase I/ II Trial in NASH

NASH or Non-Alcoholic Steatohepatitis is a liver disease with a significant unmet medical need. Effecting an estimated 35 million people worldwide, it is the most chronic liver condition in the West and patient numbers are growing rapidly. It is the leading cause of liver transplants due to the lack of approved therapies with the market for NASH therapy expected to reach $27.2B by 2029.

Recent pre-clinical programs have highlighted the adipogenic, anti-fibrotic, and anti-tumoral effects of GF-1002 positioning it as a promising treatment candidate for NASH.

By targeting NASH, Genflow Biosciences stands to benefit from a clear regulatory pathway that could lead to accelerated development and the potential for conditional fast-track approval.

[northeast14] 06/4/2024 09:18

The European Medicines Agency (EMA) said in a new reflection paper that it will consider granting conditional marketing approval to sponsors developing treatments for non-alcoholic steatohepatitis (NASH) based on the use of intermediate endpoints to address a high unmet need for these products.

The paper addresses non-cirrhotic NASH, fibrosis stage 2 and 3, and cirrhotic NASH (fibrosis stage 4).

EMA said the paper outlines a “preliminary” development strategy for these products, as their experience in this space is still evolving.

EMA said that NASH “is considered the progressive, necro-inflammatory phenotype of non-alcoholic fatty liver disease (NAFLD), which itself is the most prevalent chronic liver disease worldwide with an estimated prevalence in the Western world of around 25%, and it is estimated that about 20-50% of these suffer from NASH.”

Despite the prevalence of the disease, there are no approved treatments for NASH in the EU. In the US, the Food and Drug Administration (FDA) on 14 March approved Madrigal Pharmaceuticals Rezdiffra (resmetirom) for treating adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis).

EMA said that “due to the unmet medical need in the field, a strategy to obtain an early, conditional approval (conditional marketing authorisation; CMA) of new compounds based on these intermediate endpoints could be considered.”

This strategy will only be acceptable if an unmet need is still present, a positive benefit-risk ratio can be concluded, and the applicant can provide comprehensive data post-marketing.

For non-cirrhotic NASH, fibrosis stage 2 and 3, acceptable intermediate endpoints would be:

The resolution of NASH – with the presence of any grade of steatosis, and no ballooning, only minimal (grade 1) lobular inflammation and no worsening of the stage of fibrosis.


The improvement of fibrosis by at least 1 stage without any worsening of NASH, and no worsening of ballooning and lobular inflammation, and no more than 1 grade increase in steatosis.

For cirrhotic NASH, fibrosis stage 4, or compensated cirrhosis, the reversal of cirrhosis can be considered an intermediate endpoint. “The endpoint would need to exclude the occurrence of any decompensation event, an increase in MELD [Model for End-Stage Liver Disease] as well as a deterioration (or re-occurrence) of features of NASH activity (inflammation, ballooning, and fat) at the same time (Improvement of cirrhosis by at least one fibrosis grade without occurrence of a decompensation event and without deterioration of MELD and NAS-score).


The paper will go into effect on 1 October 2024.

[cyberbub] 04/4/2024 15:23

This is slightly disappointing, as we'd been led to believe that the company was fully funded for 2 years. To be honest I thought they might need a top up at some point, but thought it would be at a higher price later in the year, to minimise dilution. Still it seems that they've tried to keep the amount raised as small as possible at these levels. Let's hope any further raises are at significantly higher prices following news, by which I mean double figures!! :-)

[moneymunch] 04/4/2024 12:46

It's all good, and now look forward to a run of positive newsflow. Gla :-)

[northeast14] 04/4/2024 07:49

I want to know how much Premier Milton bought. Could be 1 share for all we know

[babbler] 04/4/2024 07:38

Placing done. 1.25p with 2p warrants. Onwards....

[moneymunch] 03/4/2024 13:06

Yep, an absolute steel at current share price and Genflow are still set for a great year ahead imho Gla holders:-)

[andymunchkin] 03/4/2024 11:23

dUmp phAse

[moneymunch] 02/4/2024 08:01

Genflow Biosciences (LON:GENF) (OTCQB:GENFF)

1,558 followers
7h

The first #NASH treatment is FDA approved! Despite its growing rates, the disease went largely understudied for decades - until now. Genflow Biosciences (LON:GENF) (OTCQB:GENFF) and its peers are developing life saving medicine to change the lives of millions.

Read more:

[steg] 28/3/2024 17:49

Don’t think the game plan is to take it private but you are right about the uk market, watch this space for action stateside, think the next 3 to 6 months will shape the future for us, the USA would value us more favourably but we are close to invisible for the time being. If we get a big US inst in that would pave the way, I do think because of all the excitement around Nash we will start to get traction especially if the 2025 Nash trials are in the USA, big news could come at any time. Easier said than done but patience is key, watch this space as the story starts to unfold

[cyberbub] 28/3/2024 17:23

Er ...just checked the shareholder register again, which has now been updated for Jonathan Swann so must be up to date... and Jarvis Nominees, who were shown as a 13% holding on 19th March, has vanished?? Are they the big seller?

[cyberbub] 28/3/2024 17:04

Hopefully :-)My main worry here is whether the large holders might despair at the pathetic valuation on the AIM cesspit, and decide to take the company private as a concert party. We need to see Mr Market start to give it a proper valuation, to avoid this. Hopefully this will happen once the big seller is out soon...

[moneymunch] 28/3/2024 15:38

Hopefully great timing cyberbub. Gl :-)

[cyberbub] 28/3/2024 13:49

I have bought in. I have no objection to insti money coming in, it will give confidence and help to reduce the large holders' influence as well. However it will have to be at much higher prices than 1.5p, I trust the management are clear on that!

[moneymunch] 28/3/2024 13:12

Cheers steg, we know Eric is very keen to get institutional investors on board, and so hopefully all in the pipeline along with more positive news on proceedings. The current rockbottom low will soon be a distant memory with any luck, and I had a few first thing this morning in anticipation. Gl :-)

[steg] 28/3/2024 12:56

Great research money paves the way for institutional investment, I would say game on 👍

[moneymunch] 28/3/2024 12:48

Genflow and exosome-focused biotech EXO Biologics are embarking on a three-year scientific program focusing on mRNA delivery. Supported by a grant of €1.55 million, the initiative will explore an approach using exosomes to encapsulate and transport Genflow’s SIRT6 gene therapy.

[moneymunch] 28/3/2024 12:38

27-MAR-2024

Liver fibrosis, non-parenchymal cells, and the promise of exosome therapy

Peer-Reviewed Publication

FIRST HOSPITAL OF JILIN UNIVERSITY

[moneymunch] 28/3/2024 12:32

Healthy Returns: The first drug for a common, deadly liver disease is here – and more are coming

PUBLISHED TUE, MAR 19 2024



In a landmark decision on Thursday, the Food and Drug Administration approved Madrigal Pharmaceuticals' drug "Rezdiffra," to be used along with diet and exercise. The company expects the medicine to be available next month with a hefty price tag of $47,400 per year before insurance and other rebates.

The agency's approval is also a big deal because it means Madrigal has succeeded in an area where several other drugmakers have failed – or are still trying to crack.

That gives Madrigal an edge in a market that could be huge: The MASH industry could be worth nearly $26 billion by 2032 across the U.S., France, Germany, Italy, Spain, the U.K. and Japan, according to an estimate from data analytics firm GlobalData.

Madrigal's drug is setting the bar for efficacy and safety for MASH treatment, while also opening the door for medicines still in development.

There's one important detail in the approval that could bode well for the entire MASH space: The FDA isn't requiring patients to get a liver biopsy to determine their eligibility for Madrigal's drug.

That refers to a procedure in which a doctor removes a small piece of liver tissue from a patient so they can examine it under a microscope for signs of damage or disease.

"The absence of liver biopsy requirement in Rezdiffra's label should buoy biotech stocks" of companies developing MASH treatments and "potentially accelerate and broaden patient access," William Blair analyst Andy Hsieh wrote in a note on Friday.

[steg] 28/3/2024 12:06

Classic transferring of weak share holders to the better informed going on, not convinced we will see these lows again, 2024 will provide big news in the UK and I suspect in the US followed by NASH in human trials in 2025, as they say you got to be in it to win it. Latest tr1 is just the start and the free float is getting tighter gla

[moneymunch] 28/3/2024 11:11

March 2024 Company Presentation

[northeast14] 27/3/2024 16:43

Not that I’m aware of

[cyberbub] 27/3/2024 12:15

Is rezdiffra a SIRT6 drug also?