Replies to post #251271 on Biotech Values

[DewDiligence]

Aardvark Therapeutics—(private)—has_dual-acting_small-molecule weight-loss drug_in_phase-2:

https://www.ft.com/content/e3c4130d-494d-4f69-b5fe-81833f88caed

Aardvark Therapeutics, a US biotech group developing a weight loss pill, is planning to raise up to $200mn in an initial public offering as early as this summer… Aardvark’s lead drug—ARD-101—has succeeded in suppressing hunger cravings in patients with Prader-Willi syndrome, a rare genetic form of obesity, in early-stage trials. It has shown the same promise among people with general obesity.

…Investors are excited by ARD-101, a so-called TAS2R agonist, because it does not just activate GLP-1, …but it also harnesses CCK. This second hormone could limit widely reported side effects of nausea and wastage of lean muscle mass associated with GLP-1 drugs.

One issue that immediately stands out is how Aardvark can suitably price ARD-101 for both the rare disease, Prader-Willi syndrome and the general weight-loss market.

[DewDiligence]

Housekeeping reminder—A link to the latest version of Mufaso's compilation on oral weight-loss drugs resides in the shaded box at the bottom of the main screen for the Biotech Values message board. (The link is immediately below the one for Biotech Buyouts/Premiums.)

[DewDiligence]

This unorthodox anti-obesity candidate may not warrant inclusion in your table, but here it is anyhow:

https://www.globenewswire.com/news-release/2024/04/25/2869629/0/en/Aphaia-Pharma-Provides-Enrollment-and-Protocol-Update-for-Phase-2-Trial-in-Individuals-with-Obesity.html

https://www.clinicaltrials.gov/study/NCT05385978

Aphaia Pharma is private.

[DewDiligence]

PFE questions:

1. Will PFE report Daniglipron qD data in conjunction with 1Q24 financials tomorrow?

2. If the answer to 1) is yes, what is the probability that the data are good enough to continue development of the compound?

[north40000]

Re “PFE non GLP-1, not named”: Per CNBC-TV this morning, PFE is establishing an online platform from which it intends to sell unidentified medicines directly to public. I have lost 25-30 lbs since I was first prescribed Amarin’s FDA-approved Vascepa in April 2013, off-label, in connection with my Type-1 diabetes. Vascepa is not a GLP-1, and PFE is selling Vascepa to doctors in all provinces of Canada to help patients reduce risk from CVD events. PFE has ample money to pay for media TV ads, much like BMY is now doing for some of its meds: “Check with your doctor to see if XXX is right for you.”

[DewDiligence]

AMGN obesity update: AMG736 terminated; MariTide—>full_speed_ahead:

https://www.fiercebiotech.com/biotech/amgen-axes-obesity-asset-after-ph-1-results-zooms-maritide

AMG736 is (was) an oral non-peptide drug. MariTide (a/k/a AMG133) is an injectable dual-acting agent (#msg-173774152, #msg-173783936, #msg-173784595).

On AMGN’s 1Q24 CC yesterday afternoon, executives said that AMGN conducted an unblinded interim analysis of the MariTide phase-2 in obesity and saw a “highly differentiated” profile relative to both approved and pipeline obesity meds from other companies. They also said the phase-2 has had “no problem with patient dropouts.”

As a result of the above, AMGN plans to start a phase-3 MariTide trial during 2024. The dosing interval will be monthly, or even less often, using a “patient friendly” auto-injection device.

AMGN is +12% today, boosting the stock’s market cap by more than $15B!

[DewDiligence]

TERN-601:

https://finance.yahoo.com/news/terns-pharmaceuticals-reports-first-quarter-120500965.html

• Phase 1 first-in-human clinical trial of Terns’ lead oral GLP-1 receptor agonist in obese and overweight participants is progressing

• The multiple ascending dose (MAD) portion of the study is underway, testing once-daily administration of TERN-601, and is on track to report top-line 28-day weight loss data in the second half of 2024

• Preliminary safety findings from the ongoing, blinded Phase 1 SAD/MAD study have been unremarkable to date with no observations of liver enzyme elevations, drug induced liver injury or discontinuations due to treatment-related adverse events

Why is this compound in your less interesting, “May surprise” grouping? TIA

[DewDiligence]

For your compilation—HRS-7535 and HRS-9531:

https://www.biopharmadive.com/news/hercules-hengrui-glp-1-diabetes-obesity-bain-atlas-rtw/716371/

Four life science investors are pouring $400 million into a new biotechnology startup that’s licensed a portfolio of weight loss medicines from Chinese drugmaker Jiangsu Hengrui Pharmaceuticals…

The newly created company, currently referred to as “Hercules CM NewCo,” is backed by Bain Capital Life Sciences, RTW Investments, Atlas Venture and Lyra Capital…

…Hercules’ most advanced drug, dubbed HRS-7535 , is an oral “incretin” in Phase 2 testing in people with Type 2 diabetes and obesity. Like Novo Nordisk’s fast-selling injectable drug Wegovy and multiple experimental pills in testing at Novo, Eli Lilly and other companies, it stimulates a gut hormone called GLP-1.

A second candidate, HRS-9531 , is in multiple mid-stage studies in diabetes and obesity. That drug acts on the hormones GLP-1 and GIP , the same targets as Eli Lilly’s Zepbound. Other developers, among them Roche and Viking Therapeutics, have similar therapies in testing. Hengrui’s drug is being developed as a weekly injection and as a tablet.

[DewDiligence]

Re: AZD5004 /AZN’s obesity pipeline

See slides 23-24 from today’s Investor Day for monotherapy and combination trials.

https://www.astrazeneca.com/content/dam/az/Investor_Relations/events/ID/BioPharmaceuticals-presentation.pdf

Note: ECC5004 is now called AZD5004.