Algernon Pharmaceuticals Inc (AGNPF)

[Money $hot]

A blockbuster cocktail? Gilead slides Novo Nordisk’s semaglutide into new NASH triple therapy

In case you didn’t get the memo, Gilead is betting that a cocktail approach will win them a coveted place in the NASH showdown...

As rivals — including Intercept, Genfit, Madrigal and NGM Bio, which is partnered with Merck — crowd in, Gilead has been picking up early-stage assets in pursuit of a sustaining franchise. In fact, cilofexor came from the buyout of Phenex Pharma and you might remember firsocostat as GS-0976, which Gilead paid Nimbus $600 million for.

https://endpts.com/a-blockbuster-cocktail-gilead-slides-novo-nordisks-semaglutide-into-new-nash-triple-therapy/

Can adding Novo's GLP-1 to Gilead's NASH combo help hit fatty liver disease? New trial aims to find out

A number of single agents against NASH, said by the more bullish analysts to be a $40 billion-a-year market at peak, have suffered setbacks in the clinic from a number of biopharmas, including Intercept Pharmaceuticals, Gilead itself, GenFit and others. Gilead will hope combinations can be a new way forward and help clear more fat from the liver to reduce the risk of further damage.

https://www.fiercebiotech.com/biotech/can-adding-novo-s-glp-1-to-gilead-s-nash-combo-help-hit-fatty-liver-disease-a-new-trial

Here's my takeaway from the above articles. Big Pharma is also turning to combination drugs to treat NAFLD/NASH Disease. This opens up a huge opportunity for Algernon Pharmaceuticals to secure a partnership with it's Lead Compound NP-135. Gilead's triple drug combination suggests there's an unlimited number of deals that could be had with big pharma. Big Pharma is beginning to place their bets all over the board. Gilead paid 600 million for firsocostat (GS-0976) @ Phase II. Firsocostat has since been added to Gileads combination drug Phase II clinical trial. Meaning, firsocostat has never been in a Phase III clinical trial, standalone or in combination. Info regarding Gileads "Cocktail" Phase II clinical trial:

Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (ATLAS)

Study Design
Study Type : Interventional (Clinical Trial)
Actual Enrollment : 395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

https://clinicaltrials.gov/ct2/show/NCT03449446

Algernon Pharmaceuticals Lead Compound showed 84.4% reduction of fibrosis in liver disease (NASH), and 52.1% reduction of fibrosis in chronic kidney disease (CKD). I have yey to find any comparative data that comes even close to Algernon's preclinical findings. Given that big pharma is looking to treat NAFLD/NASH with combination drug therapy, Algernon's Lead Compound NP-135 would pair up nicely with any drug targeting Fatty Liver. Algernon Pharmaceuticals appears to have the Liver Fibrosis side of the equation on solid footing in preparation for Phase II clinical trial.

Big Pharma/NAFLD~NASH/Combination Therapy



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