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How many drugs get thru phase 1 with that type of data and never get approved or take a few years at minimum to get approved. There is still a fairly high degree of risk.
If Luly can provide some color on what the approval process is it would be great.
I will probably miss out on a lot of ENTA gains or maybe never have a chance to get in because I’m waiting for some patient results that show the drug works.
Thanks dew. Seen that info on twitter and didn’t check into much because I’m in Belize diving.
Wishing ENTA well. I will probably miss out on a lot of ENTA gains or maybe never have a chance to get in because I’m waiting for some patient results that show the drug works.
It would be nice to see this drug work. While I’m here I found out my daughter who has trisomy 21, OCD and Autism got Covid. She has been vaccinated and boosted but she is also in the high risk group. Kept her away from Covid for 2 years literally the dayI leave she tested positive. Trying to get Pax for her.
R
I hope you are right. You sure nailed the other call; up $5.50 last Friday and up $4.50 today. 10 bucks in two days and 7 more days to go till earnings.
Biden is still positive for covid.
The rebound may be getting more attention than it would have a month or two earlier.
It may create a sense of urgency in tracking what the ideal dosing period is.
I hate to say.... or I have to say carefully---- It is good that they will have another decent or better antiviral to test against the Paxlovid benchmark. They are bound to learn a lot.
If Luly can provide some color on what the approval process is it would be great.
By no means do they seem to have this pandemic under control.
ENTA is up over $3 today. I figured the rise over the release of the safety data on friday would continue this week. The questions remaining in my mind are how many days in a row will the stock price rise, and will it get to the mid $60s or, dare I say it, get back to $70 before the earnings report is released?
Shionogi’s S-217622 has some issues:
#msg-168536263 teratogenicity
#msg-169462279 efficacy not proven
More info on S-217622 than you probably wanted to know:
https://www.biorxiv.org/content/10.1101/2022.01.26.477782v1.full
Conclusions
• Data presented in Ph1 first-in-human study indicate that S-217622 was well tolerated in healthy individuals, and the pharmacokinetics evaluations highlighted the potential for once-daily administration
• In Ph2a, treatment with 5-day oral administration of S-217622 demonstrated a rapid clearance of SARS-CoV-2 and was well tolerated in patients with mild-to- moderate or asymptomatic infection
• The results support further clinical development of S-217622 through large-scale clinical studies for the treatment of mild-to-moderate or asymptomatic SARS- CoV-2 infection
https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2022/ECCMID%20Ph1_2a%20presentation%20final2.1.pdf
What if Enanta did a 6 day versus 5 day (or 5 and 6 day cohorts) and there were no rebounds, even in a larger pool?
So both Fauci and now Biden have rebounded. I agree that it may not be a serious problem, but it may pose an opportunity.
Getting to your second point- an approved drug that doesn't use Ritonavir may be more likely to be approved immediately by a doctor or pharmacist- thereby treating more immediately, having lower viral loads, less secondary immune/inflammation reactions, a quicker and more complete recovery. That may be more true for the older or more immune compromised or those with other co-morbidities. That's where we are really seeing the serious health consequences.
In short- there looks like there is a lot of need and potential upside to EDP-235.
I don't think the viral rebound phenomenon is that common or too much of a problem. EDP-235 may have even less of a problem with rebound given its high potency and long half-life.
The biggest advantage for EDP-235 is indeed that it doesn't use ritonavir, and that advantage will be greatest in older patients since they are at higher risk for Covid and more likely to be taking other drugs.
Covid isn't going anywhere.
It also seems that problems with viral rebound are happening (Paxlovid -too weak or too short a duration??)
Recent virus strains are evading vaccines.
Many doctors are hesitating to prescribe due to the complicated nature of drug interactions w/ Ritonavir.
The last thing on the sheet I really liked?
"Select third mechanism for HBV combination regimen with EDP-514" (in 2022)
I believe that Enanta has reinforced confidence in their capabilities with antivirals.
If they can come up with a third compound for HBV......
[Slide #31]: "Select third mechanism for HBV combination regimen with EDP-514" (in 2022)…
Yesterday was a great day for Enanta.
I'm sure that the Earnings call will shed more light on the covid development plan.
Covid isn't going anywhere. Covid is evading vaccines, and other troubling issues like reinfection, long covid and additive damages from reinfections suggests we need a better antiviral.
It also seems that problems with viral rebound are happening (Paxlovid -too weak or too short a duration??)
Recent virus strains are evading vaccines.
Many doctors are hesitating to prescribe due to the complicated nature of drug interactions w/ Ritonavir.
So the emergency isn't really quite over- infections are once again rising.
There is a need for a faster pathway to approval for EDP- 235
The last thing on the sheet I really liked?
"Select third mechanism for HBV combination regimen with EDP-514" (in 2022)
I believe that Enanta has reinforced confidence in their capabilities with antivirals.
If they can come up with a third compound for HBV......
ENTA’s updated corporate slide set—(including new EDP-235 info):
https://ir.enanta.com/static-files/fb5db89a-b15b-4820-9e77-b8c5b087f869
Slides 17-21 pertain to EDP-235. Slide 20 shows comparative potency vs other agents.
Agreed. EDP-235 is plainly more potent than Paxlovid. And without the manifold drug-drug interactions consequent to ritonavir, EDP-235 should be considerably safer than Paxlovid too.
The clean safety profile of EDP-235 is the biggest news in today's dataset. That's because the MoA of EDP-235 is well understood, so efficacy at the doses selected for phase-2 is almost a fait accompli.
ENTA’s PR on EDP-235 phase-1/1b data:
EDP-235 exposure increased approximately proportionally with increasing single and multiple doses, with a consistent half-life ranging from 13 to 22 hours, resulting in a PK profile suitable for once-daily dosing. Exposure was enhanced with food administration of a standard meal. EDP-235 once-daily taken with food, resulted in mean trough plasma levels at steady state that were higher than the plasma protein adjusted EC90 of EDP-235 in Vero cells as follows:
200mg: 3-fold for Alpha and 6-fold for Delta variant
400mg: 6-fold for Alpha and 12-fold for Delta variant
Considering a preclinical lung to plasma ratio of 4:1, lung levels are predicted to be as follows:
200mg: 12-fold for Alpha and 24-fold for Delta variant
400mg: 24-fold for Alpha and 48-fold for Delta variant
ENTA’s PR on EDP-235 phase-1/1b data:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-positive-data-phase-1-clinical
Based on these positive safety and PK results, ENTA is advancing the 200mg qD and 400mg qD doses (without ritonavir boosting) to phase-2, which is expected to start in 4Q22.
Yes, as far as I know.
Are we due for a PR today or tomorrow on EDP235?
All of those reasons plus the scary stuff people some people are writing about Omicron BA.5.
ENTA broke $51 this morning. The stock price dropped to just under $39 in mid June. This rebound could be a delayed response to the the law suit for patent infringement against PFE, anticipation of the phase I safety data for their Covid-19 protease inhibitor EDP-235, a general rebound after a long decline or all three. We should soon know about the phase I data as ENTA is expected to release that data this month.
The Canada approval is for the pediatric market (age 3-11).
The Canada approval is for the pediatric market (age 3-11). Mavyret was already approved in Canada for adults and adolescents.
It may be as simple as Enanta was the first to patent. The Pfizer PI entered trials spring of 2021.
I just saw that Canada approved the use of Maviret and stated that ~250,000 patients are in this category. I wonder if Canada is just late to the party or whether they are early so a new substantial patient population may soon be realized in many countries.
https://finance.yahoo.com/news/maviret-glecaprevir-pibrentasvir-approved-health-120000965.html
Wow!
Thanks for providing the link as it gets into the specifics of the suit.
Even so it is difficult for me to clearly see what the courts will decide.
One must assume that Pfizer must have some sort of IP and response.
I am reminded of Gilead being sued for Sovaldi.
This is going to be a nail biter.
I hope that it has a Hollywood ending for Enanta investors.
It may be as simple as Enanta was the first to patent. The Pfizer PI entered trials spring of 2021.
(ENTA)—PFE’s guidance for 2022 Paxlovid sales is $22B, of which a substantial portion is from the US market.
If ENTA’s patent suit resulted in even a low-single-digit royalty on US sales of Paxlovid, it would amount to a very sizable payday relative to ENTA’s existing enterprise value.
Addendum—ENTA is not seeking an injunction against Paxlovid, which would be morally deplorable. Rather, ENTA is seeking monetary compensation for the alleged patent infringement.
ENTA sues PFE for patent infringement wrt Paxlovid:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-files-patent-infringement-suit-against
Enanta Pharmaceuticals…announced today that it has filed suit in United States District Court for the District of Massachusetts against Pfizer, Inc. seeking damages for infringement of U.S. Patent No. 11,358,953 (the ’953 Patent) in the manufacture, use and sale of Pfizer’s COVID-19 antiviral, Paxlovid (nirmatrelvir tablets; ritonavir tablets). The United States Patent and Trademark Office awarded the patent to Enanta earlier this month based on Enanta’s July 2020 patent application describing coronavirus protease inhibitors invented by Enanta scientists.
ENTA’s CEO exercised and held $140K of stock from an expiring option:
https://pro.edgar-online.com/displayfilinginfo.aspx?source=external&tabindex=2&FilingID=15902360&Type=HTML&Text=
Exercising and holding—paying the withholding tax with cash rather than forfeited shares—is mathematically equivalent to an open-market purchase.
EDP-235 data release will occur in July (not June).
This is a positive change, IMO—please see #msg-169100861.
ENTA has committed to releasing some or all of the EDP-235 phase-1 data during the current calendar quarter (i.e. by Jun 30). On the recent CC, Jay Luly was asked whether the initial data release would include all of the dosing cohorts or just some of them, and he said that the decision hadn’t yet been made.
Apropos the safety data set for EDP-235. What is the expectation on the release from a timing perspective? Admittedly I apologize I lost track. Thank you in advance.
Thanks Dew. The second to last slide (#29) lists the key catalysts for 2022. One of them is to select a third mechanism for combination regimen with EDP-514 for HepB treatment. I will feel better when the candidate(s) are announced and into trials.
Follow-up—After all the commotion, ENTA closed down only 4% today. Thus, the EV still has some value baked in for EDP-235, but not a lot.
New corporate slide set (5/18/22):
https://ir.enanta.com/static-files/fb5db89a-b15b-4820-9e77-b8c5b087f869
Only update is the RSVP result.
On the heels of this disappointing RSV trial, ENTA is riskier now
ENTA’s phase-2b trial in RSV misses primary endpoint:
ENTA’s valuation:
https://twitter.com/DewDiligence/status/1527054722707992577
Please see #msg-168831164 and #msg-168831159 for calculations regarding ENTA’s EV.
ENTA’s phase-2b trial in RSV misses primary endpoint:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-topline-data-rsvp-study-edp-938
From the recent price action, it seems that this result may have been leaked.
NIH wants_to_study longer treatment_course for Paxlovid:
NIH wants_to_study longer treatment_course for Paxlovid:
https://finance.yahoo.com/news/u-study-whether-longer-paxlovid-162143570.html
The Paxlovid treatment course under the existing EUA is 5 days. However, this is not because 5 days is necessarily optimal, but rather because 5 days is how long the treatment was in PFE’s phase-3 clinical trial.
@George Rho
Thanks for reading and for your interesting comment.
I appreciate your insights on its COVID therapy. I seldom discuss early stage projects in my articles, no matter how potentially transformative they may be. This goes doubly for early stage COVID therapies. There are just too many molecules with fabulous potential and intriguing clinical breadcrumbs for me to highlight any one. Every time I think something will break free from the pack, I am disappointed. Most recently Omeros' narsoplimab was my fair hair boy.
As for the reason underlying the spike last year, you sound like you have better insights on that than I do; you played it well selling at $90.
Recent ENTA News
I added last week at about $50.00
....after I swore I wouldn't till there was some hard data or positive catalyst. : )
I rather expect at some point another HBV candidate to combine with EDP 514.
Or the announcement of a partner in covid after the drug shows promise.
I added last week at about $50.00
....after I swore I wouldn't till there was some hard data or positive catalyst. : )
I rather expect at some point another HBV candidate to combine with EDP 514.
Or the announcement of a partner in covid after the drug shows promise.
We are half way thru the 2nd quarter so news on Covid and RSV are right around the corner.
Out of Ignorance profile picture
Out of Ignorance
Today, 10:18 AM
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@George Rho
Thanks for reading and for your interesting comment.
I appreciate your insights on its COVID therapy. I seldom discuss early stage projects in my articles, no matter how potentially transformative they may be. This goes doubly for early stage COVID therapies. There are just too many molecules with fabulous potential and intriguing clinical breadcrumbs for me to highlight any one. Every time I think something will break free from the pack, I am disappointed. Most recently Omeros' narsoplimab was my fair hair boy.
As for the reason underlying the spike last year, you sound like you have better insights on that than I do; you played it well selling at $90.
George Rho profile picture
George Rho
Today, 4:21 AM
Comments (1.11K)
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I read your bio with some interest. I, too, like to learn from the responses of readers, although some can be harsh. Indeed, I started to pen an article on Alector recently, mainly to glean what others might see that I was apparently missing. Just briefly, the stock about doubled in price last summer after it inked a significant partnership with Glaxo, but has been on an extended slide ever since, the huge cash horde and pipeline prospects notwithstanding. In any case, laziness set in and I didn’t get far beyond the starting point.
As to your article, it left me feeling that you’d left out way too much, especially for someone who is familiar with the March quarter conference call. Principally, you completely ignore the Covid pill that’s under development. It apparently has the potential to be superior to both Pfizer’s and Merck’s Covid drugs, in terms of efficacy, dosing, and administration. As you undoubtedly know, both are huge sellers, massive enough to move the needle on the bottom line even though both companies have billions of shares outstanding.
To be sure, it’s only in phase 1. But it has received fast track designation. Plus, as evidenced but Pfizer’s and Merck’s, the clinical program shouldn’t take too long since there are many eligible patients out there and the drug is taken for only four or five days. Also important to note is Enanta’s minuscule equity base, at about 20 million shares outstanding. Imagine the impact of a billion dollars in sales on the bottom line.
Another fact you didn’t cover in your article was the reason for the sharp rise in share price last year. For whatever it’s worth, I bought the stock many years ago for the company’s hcv products and sold it last year at $90. I’ve been rebuilding my position over the past several weeks. If I were a betting man, I’d put my money on Enanta partnering with Abbvie for the Covid product, too. Full disclosure, I’m long both and have written articles on each.
A very worthwhile reply to the article is in a first response in the reply section.
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