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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.)
TLPH. Hi Dew ...understand that this is a layman's read . My wife who rounds dialysis clinics is loath to discuss her work / patients unless she initiates the conversation / vent.
The issue is primarily in the ICU dialysis setting . Heparin and Citrate have relatively long half lives and recirculate from the dialysis lines back into the patient . These patients in the ICU often have bleeding issues and may be intolerant to Heparin and Citrate.
Nafamostat has a very short half life so far less of it gets recirculated back into the patient. .
In non ICU dialysis its use may be for those intolerant to heparin and citrate .
My quick layman take
Believe its FDA designated as Breakthough and they agreed to device track for approval based on extensive history in Korea and Japan
Kiwi
Questions about TLPH:
Is nafamostat intended only for ICU dialysis, or for dialysis in general?
How is nafamostat superior to other anticoagulants used in dialysis?
Why is the FDA treating TLPH's nafamostat as a device rather than a drug?
TIA
TLPH. Listened to their 3/4 CC . The drug they are trialling has been used for decades in Japan and Korea ( so good safety profile ) but FDA requires a short trial in US before approving here .
Renal KOL's are very interested in getting this drug / treatment approved because of the problems they face using heparin and citrate in ICU dialysis .
Sites have been slow to be approved due to administrative back log at the academic hospitals that will run this short trial ....but some should be up and running 4/1 onwards .
Short trial ...patients are only on drug for max 72 hrs , DMS safety signal at 32 patients , results expected Q3
Nantahala has provided recent financing and now has a seat on the BOD.
COH to early 2025
Interesting spec
Small position
Kiwi
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.
Its a Mark Twain quote and you can google it:
"Figures don't lie, but liars figure." Through this early quote, Mark Twain ruminates about deceptions run rampant; numbers used by phony wizards as illusions of truth, while feeding people's hunger for answers prescribing the calming paregoric of snaky prevarications
Liars game? Could you expand on this? Thank you! Randy
The clinical study of 391 subjects found that patients taking Altimmune’s Pemvidutide loss an average of 16% of weight after 48 weeks. Of that weight, 75% of it derived from a loss of fat, while only 25% came from a loss of lean mass. This ratio is comparable to weight loss achieved with diet and exercise.
For comparison, a clinical trial of the active ingredient in Wegovy and Ozempic looked at a subgroup of 140 patients to see its effects on lean muscle mass. Participants in this group lost an average of about 15 pounds of lean muscle (40%) and 23 pounds of fat (60%) over 28 weeks.
Re $BTTX: By restructured I mean a new loan for the company.......has nothing to do with shareholders.......
Z
I guess I have spellcheck spellcheck more often.
VKTX—So how does that [infographic on the advantages/disadvantages of peptide drugs] translate to VK2735 in your opinion?
XLO—I'm still bidding 1.20's in afterhours as I'm 100% certain GILD knows more than I do concerning this specific matter.
BTTX—Debt can be restructured…
And everybody involved believes in the AspireRX product…
XLO 1.25 - (clarification) 8K released afterhours:
Item 8.01. Other Events.
As previously disclosed, in connection with Xilio Development, Inc., a wholly-owned subsidiary of Xilio Therapeutics, Inc. (the “Company”), entering into an exclusive license agreement with Gilead Sciences, Inc. (“Gilead”), on March 27, 2024, the Company entered into a stock purchase agreement with Gilead pursuant to which the Company agreed to, among other things, initially issue and sell 6,860,223 shares (the “Gilead Shares”) of its common stock, $0.0001 par value per share (the “Common Stock”), to Gilead in a private placement at a purchase price of $1.97 per share, for an aggregate purchase price of approximately $13.5 million (the “Initial Gilead Private Placement”). The Initial Gilead Private Placement closed on March 28, 2024.
As of March 25, 2024, the Company had 27,613,263 shares of Common Stock outstanding. Following the issuance of the Gilead Shares upon the closing of the Initial Gilead Private Placement on March 28, 2024, the Company had 34,473,486 shares of Common Stock outstanding.
https://www.sec.gov/edgar/browse/?CIK=1840233&owner=exclude
I'm still bidding 1.20's in afterhours as I'm 100% certain GILD knows more than I do concerning this specific matter.
Debt can be restructured.........And everybody involved believes in the AspireRX product.........fwiw
Z
Jbog- I agree the pricing should and will drop. How much will depend on how many people actually take the drug. What is the key here and I hate to sound like a broken record but the answer is tolerability.
Goldman Sachs projects that between 10 million and 70 million Americans will be taking weight loss drugs by 2028. You might think Goldman is of base with such a wide variation but they are not in my opinion as it depends on tolerability and price. (Note- nearly 40% of the US population is obese so 70M is less than half and that's not counting people who are just overweight)
The total market could remain $100B (or you pick the number) and once you know how many people are on the drug, you then know the approximate pricing. (At one time Lipitor was the biggest selling drug of all time and it didn’t have that high of a retail price.
Lots of variability here but I think enough competition and manufacturing capacity will eventually exist so that the manufacturers and the insurers come together and come to a figure like you suggest. (I think your $200 to $300 is likely once an exceptionally tolerable drug like VK2735 is on the market for a few years
PS- In your post I think you meant ludicrous not lubricous. Check out the definition of lubricous at Dictionary.com https://www.dictionary.com/browse/lubricious or better yet just google it. LOL
BTTX…has dropped 92% from $1+ price only 8 months ago…
Thanks I’ll check out the study. The typical confounders in observational cohort trials like this are really controlled for here so it sounds like this could be pretty compelling data
RE the study published June 2023 about Wales data set - from https://finance.yahoo.com/news/vaccine-may-help-protect-against-161500715.html
>>>>>>>>>>>>
The study took advantage of something that happened in Britain in 2013, when the country’s National Health Service rolled out shingles vaccines for everyone born on or after Sept. 1, 1933, but completely excluded those born before that date. Pascal Geldsetzer, a professor of medicine at Stanford and one of the study’s authors, says this created a real-world experiment similar to the kind you get in a lab, where people of similar age—in some cases just a few days or weeks apart—were randomly assigned into two groups.
“We are able to get credibly a causal effect because we are able to exploit this really unique way that the shingles vaccine was rolled out in Britain in the National Health Service,” he tells MarketWatch. “It allows us to compare people who differ by just a week or two in their age. I think it’s a really neat, clean way to mimic what we would do in a clinical trial.”
Incidentally, these U.K. numbers might significantly understate any impact of shingles vaccines on future dementia, although we cannot know for sure. In most cases, those who got a vaccine only got one, rather than successive boosters. The follow-ups were only within seven years. And the study looked only at those who were given the vaccine in their 70s or older.
>>>>>>>>>>>
$BTTX - Super Bounce? - Easter Special
Has dropped 92% from $1+ price only 8 months ago
Mufaso,
With the lubricous pricing that Novo started with I also thought there will be the $1000 drug, maybe a $700 and maybe a $200 Drug. I've always claimed that the measuring stick of how much you can lose in xx weeks is absurd. Just put the people on a trendline as comfortably as possible.
ENTA is quietly +70% since the post I’m replying to from six months ago.
Moral: A dirt-cheap valuation can be a strong catalyst in its own right.
Please elaborate. TIA
The XLO deal is tantamount to a call option for GILD.
Jbog- ALT pemvidutide has the cardio benefit of not increasing heart rate and if you add low muscle vs fat loss to the mix, it does seem like it could make some real noise on making it to market. Add that they think it is effective in NASH and .... The main thing is they need to prove tolerability through their titration plans.
The muscle vs fat argument so far has been a "liars figure and figures lie game so far." I'm not saying Alt is making anything up just that a more scientific data based approach is needed before a judgment can be made.
I'm monitoring ALT but as of yet have not taken the plunge.(want to see proof of good tolerability). There will be multiple winners in obesity and there are multiple addressable segments in the category.
XLO - what's your opinion of this new GILD collaboration...any meat on the bone there? XLO still qualifies as a near-cash play. I might re-enter on any dip to 1.20's at the close in anticipation of a likely gap up in Monday's premarket.
Mufaso,
I'm taking everyone with a grain of salt until this gets sorted out.
Today Riley came out with this:
Altimmune has 'ideal lifestyle anti-obesity drug,' says B. Riley
B. Riley says Altimmune's Q4 earnings were headlined by two additional Phase II MOMENTUM obesity study findings, in follow-up to previously reported positive top-line data.
The new body composition sub-study data noted better quality of weight loss attained relative to more advanced weight loss drugs as only 25.5% of total weight loss was attributed to lean mass, which is comparable to normal diet-driven weight loss, the analyst tells investors in a research note.
In addition, new liver fat reduction data showed up to 79% subjects attained liver fat normalization, which reaffirms the "material de-risking" of the company's ongoing Phase II IMPACT 24-week liver biopsy metabolic dysfunction-associated steatohepatitis study readout anticipated in Q1 of 2025, says the firm. Riley believes the 25% lean mass reduction makes pemvidutide an "ideal lifestyle anti-obesity drug." It reiterates a Buy rating on Altimmune with a $20 price target.
Read more at:
https://thefly.com/n.php?id=3889181
VKTX Analyst praise has been strong but I thought this comment was especially noteworthy:
If approved, VK2735 would almost certainly become a blockbuster. William Blair analyst Andy Hsieh projects the drug could reach peak annual sales of around $14.4 billion in the U.S. with another $7.2 billion in sales in Europe.
RZLT. DME P2 results in Q2
https://www.rezolutebio.com/for-patients/living-with-dme/
Kiwi
Ps. I've been selling some on the way up so I don't do a face plant on this if P2 fails
“poorgradstudent” is on Twitter under his real name, but he hardly ever tweets:
XLO—(+130%)—inks GILD collaboration—$43.5M up-front cash (including a $13.5M equity purchase):
https://www.businesswire.com/news/home/20240328734624/en
The GSK data set is pretty close to getting a randomized trial the way NHS in the UK implemented Shingrix vaccine eligibility. The difference in long term follow-up data is pretty stark.
“poorgradstudent” is on Twitter under his real name, but he hardly ever tweets:
https://twitter.com/Ogut_Ozgur
Indeed he did: #msg-111031090.
tHANKS 1.97 NOW
Message in reply to:
FDA—(belatedly)—approves AKBA’s Vafseo—(vadadustat)—for_dialysis_patients—stock declines:
https://finance.yahoo.com/news/akebia-receives-fda-approval-vafseo-002600187.html
Speaking of Martin Shkreli he had a cameo on this board right when his news started swirling IIRC
Speaking of Martin Shkreli he had a cameo on this board right when his news started swirling IIRC
FDA—(belatedly)—approves AKBA’s Vafseo—(vadadustat)—for_dialysis_patients—stock declines:
https://finance.yahoo.com/news/akebia-receives-fda-approval-vafseo-002600187.html
He’s a serial dealmaker. Patrick somehow managed to avoid being tarnished by his close association with Martin Shkreli.
Patrick Crutcher, who used to be a co-moderator of this message board.
BOLD IPOs 7.19M* shares @$16.00:
https://www.businesswire.com/news/home/20240327704934/en
Boundless Bio is a clinical-stage oncology company dedicated to unlocking a new paradigm in cancer therapeutics to address the significant unmet need of patients with oncogene amplified tumors by targeting extrachromosomal DNA (ecDNA), a root cause of oncogene amplification and observed in more than 14% of cancer patients.
Boundless Bio is developing the first ecDNA-directed therapy (ecDTx), BBI-355, which is an oral inhibitor of checkpoint kinase 1 (CHK1) and is being evaluated in a Phase 1/2 clinical trial in patients with oncogene amplified cancers. Boundless Bio’s second ecDTx, BBI-825, is an oral inhibitor of ribonucleotide reductase (RNR) and recently entered a Phase 1/2 clinical trial in cancer patients with resistance gene amplifications.
UPDATED-List of ORAL Weight loss candidates.
03/27/2024 Changes:
Most Interesting NME's as peptides/large molecules
Owner Drug MOA Comments
VKTX VK2809 GLP1/GIP Had exceptional tolerability in Ph1 while providing 3.3% weight loss vs placebo. Longer/larger trial may show improved benefits due to long half life.
NVO Amycretin GLP1/Amylin Great topline wt. loss in ph1 but... Not progressing until injectable form data out..very limited data released by NVO…small study. This is a combination of GLP1 and amylin a single drug.
Most Interesting NME's small molecules
Owner Drug MOA Comments
LLY Orforglipron GLP1 In ph2 the highest dose of 120mg got 3% weight loss at 4 wks, 8% at 8wks, and 13% at 36 weeks per GSBR comparison presentation
AZN ECC5004 GLP-1 In Phase 1- small molecule GLP1- AZN paid 185mill + up to 1.8B milestones + royalties for compound
PFE PF-06954522 GLP-1 GLP1 for Type 2 Diabetes - just entered Ph1- very little info
Kallyope K757&K833 Hormone new oral nutrient receptor agonists that stimulate the secretion of multiple appetite-suppressing satiety hormones
AMGN Not Named Undisclosed Unknown
GPCR GSBR-1290 GLP1 Structure Therapeutics -In larger ph2 study only showed 4% weight loss at 8weeks and look inferior to LLY's Orforglipron for both weight loss and T2D (Significant weight loss shown in 28day Phase 1 (up to 4.9%) was not borne out in larger ph2 study)
NodThera NT-0796 NLRP3 Not as effective as a GLP1 for weight loss but may be for those who can't tolerate GLP1 or has cardio issues
PFE Not Named "GLP based" Oral in Ph1- mentioned Leerink. M Dolsten said ->The second is another GLP-1 that has some different features also in the clinic and looks encouraging when it comes to PK and dose.
PFE Not Named "Non-GLP1" See #msg-173587109. Also- At Leerink M Dlosten said "But it's one of those mechanisms that being validated by biologicals from companies that are in that space,...the type of mechanism that you hear from Lilly and Novo. ... being the first company to make an oral version of it.
Empros EMP16 "Non GLP1" Avg 8% wt. loss over a year. targeted at maintenance. Uses a combo of two off patent drugs Orlistat and Acarbose.
May surprise
Owner Drug MOA Comments
PFE PF-06882961 GLP1 Danuglipron- Small Molecule- completed ph1 and in ph2b
NOVO Rybelsus GLP1 Semaglutide- approved for Diabetes only but used off label
TERN TERN-601 GLP1 Management discussing this drug in combination- not competitive standalone?
Not going forward
Owner Drug MOA Comments
PFE Lotiglipron GLP1 Discontinued due to elevated liver enzymes
So how does that translate to VK2735 in your opinion?
I think we will simply need to disagree here until such time as more data becomes available.
I used any on purpose here. None of the mono agonist GLP1's have shown any Liver specific special abilities. I don't think any of the GLP1's best in class or not will be especially useful in a combo NASH therapy.
I think we will simply need to disagree here until such time as more data becomes available.
That's a handy chart. I would submit, however, that bioavailability is more relevant than the chart might lead one to believe insofar as it directly or indirectly causes several of the other cited advantages and disadvantages.
Picking any small molecule GLP1 is not likely to be as effective.
one has to wonder why an oral peptide drug for obesity would be a better option than a best-in-class oral small-molecule drug.
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Biotech Values is a forum for discussing
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