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As a concern for ENTA shareholders, this is way down on the list. The subject has been discussed several times on ENTA's CCs.
Thanks. How concerning is the possibility of protease mutations that would diminish EDP-235 efficacy?
Impact of SARS-CoV-2 3CL Protease Mutations on Nirmatrelvir Inhibitory Efficiency. Computational Insights into Potential Resistance Mechanisms
ENTA has undoubtedly run the tests you are referring to, but this doesn’t warrant a press release or a new version of the corporate slide set. The additional info should be in the next version of the slide set, which will presumably be released in time for the JPM conference in January.
BQ.1.1 has been around since Sept and the slide deck was posted on Nov 21 and now we're almost into 2023 with no update. Why is it taking so long for ENTA to run a test and update their slide deck or make an announcement?
It shouldn’t be a problem insofar as the main protease (what EDP-235 inhibits) is highly conserved across SARS-CoV-2 variants.
Since Omicron variant BQ.1.1 is resistant to all treatments and is now >57% of all cases in the U.S. and there's no assay listed on slide 19 for BQ.1.1 is that something to be concerned about?
New COVID Subvariant Resistant to All Therapeutic Antibodies
Omicron variant BQ.1.1 found to be resistant to all monoclonal antibody treatments
I am getting whiplash watching ENTA's day to day fluctuations. For some reason the upswings feel a lot better than the downswings. :)
Jay Luly exercised and held $620K of stock today:
https://www.sec.gov/Archives/edgar/data/1177648/000106299322024173/xslF345X03/form4.xml
The options in question did not expire until Dec 2023. Moreover, Luly paid the tax due from the exercised shares in cash rather than in forfeited shares, which makes the exercise-and-hold action mathematically equivalent to an open-market purchase in terms of bullishness.
Note: This exercise-and-hold action was not triggered by Luly’s 10b5-1 plan.
Much of what I am looking at is in the red today.
Further, some Enta (-6.3%) similar small caps are down; AGIO -5.5%. PRDS -13.8%, and ABUS -10.7%. A sea of red.
It seems to me that this December selling is quite common for Enanta. I've also seen large gains also in the New Years period.
FWIW I at one time held MDGL but got impatient and years earlier sold the few shares I had; It was a win in a way cause they were no longer a distraction. The Enanta covid program OTOH has a relatively near time frame readout that very well could distinguish itself from other antivirals.
Low volume trading but a big drop in ENTA today on no news. It must be tax loss selling. With the news that China is easing up on their zero Covid policy and that Covid infections are rising dramatically, China would represent a great market opportunity for EDP-235, well if it ever gets approved.
More_on_the_same_story—Paxlovid sales in China:
https://finance.yahoo.com/news/3-china-meheco-distribute-pfizers-180624462.html
Pavlovid sales are ramping up in China:
https://finance.yahoo.com/news/1-china-health-app-starts-093451036.html
Ascletis Pharma (OTCPK:ASCLF) said China's National Medical Products Administration (NMPA) approved its investigational new drug (IND) application to start a trial of oral drug ASC11 for COVID-19.
The goal of the phase 1 trial, which is expected to be completed within Q1 2023, is to identify a safe and efficacious dose for the pivotal phase 2/3 in patients with COVID-19.
In addition, the phase 1 study will determine if ASC11 needs to be boosted by ritonavir or not.
The Chinese company said that in antiviral cellular assays with infectious SARS-CoV-2, ASC11 showed much higher potency against the virus than other 3CLpro inhibitors including nirmatrelvir, Shionogi's (OTCPK:SGIOF) (OTCPK:SGIOY) oral drug S-217622, Pardes Biosciences' (PRDS) oral therapy PBI-0451, and Enanta Pharmaceuticals' (ENTA) oral medicine EDP-235.
Pfizer's (PFE) Paxlovid consists of (nirmatrelvir and ritonavir).
"The IND approvals of ASC11 from both China NMPA and U.S. FDA mark a great recognition to our in-house R&D capabilities," said Ascletis Founder, Chairman and CEO Jinzi Wu.
Ascletis added that ASC11 has potent antiviral activity against several Omicron variants such as BA.1 and BA.5. In the animal model with infectious SARS-CoV-2, ASC11 also showed potent antiviral activity, according to the company.
PFE enlists Clear Creek Bio (private) to develop an oral inhibitor of the SARS-CoV-2 papain-like protease (which is distinct from the SARS-CoV-2 “main” protease that is targeted by Paxlovid):
https://finance.yahoo.com/news/pfizer-clear-creek-bio-collaborate-114500791.html
This collaboration is a tacit admission by PFE that Paxlovid is far from an ideal answer to the question of how endemic COVID should be treated.
Financial terms were not disclosed.
Makes sense , thanks Dew. It’s not a trading vehicle for me.
The selloff during the past three months was triggered, in part, by Biden saying (prematurely) that the pandemic was over.
Day-to-day movements in the share price are almost meaningless (unless you're trading them) because the volume is so low.
Agree . Any particular reason it got sold off lately? Healthcare overall doing ok. Really surprised by the reaction. I am a shareholder of ENTA. I mean 7 percent drop on holiday weekend ? For no reason !!
ENTA's EV at the current share price ($41.58)=~$750M—down sharply from ~$1.4B three months ago.
If there's a better $750M-EV biotech stock out there, I don't know what it is.
ENTA’s fully-diluted share count @9/30/22=25.2M—an increase of 0.5M since 6/30/22 (#msg-169621216).
The 25.2M figure above consists of: 20.8M basic shares on the 9/30/22 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017022025667/enta-20220930.htm#consolidated_balance_sheets ); and 4.4M options and unvested restricted-stock equivalents (whether or not exercisable) (ibid, page F-13).
There will be no phase 3 in high risk pts. Due to the availability of molnupiravir and Paxlovid, it is unethical for a physician to give a placebo to a high risk patient. There is no regulatory framework for this.
Thanks for the reply. There is no phase 3 trial for EDP-235. It is in a standard risk phase 2. This won’t work (again, see real clinical results from the Paxlovid trial) and won’t get to phase 3.
Did I miss anything there?
The Paxlovid standard risk population trial did not meet its endpoint with statistical significance.
Paxlovid does not work in standard risk patients. Check your data. EDP-235 won’t work either.
Deflectors on maximum.
1) you know nothing about making a drug
2) you know nothing about clinical trials
3) long time listener, first time caller
For laughs? Not trying to laugh. Just trying to be objective. And I’m not short anything.
A good example for you is any of the RSV therapeutics- all failed. Great exposures and great potencies - no translation. My point is that just because something is potent and has good PK, that doesn’t mean it will translate into a cure for an acute infection. Remember, this is a phase 2 in standard risk, highly seropositive population with a safety primary endpoint. A very hesitant step, you must agree.
Yes this is a validated MoA. But, they are not showing their full hand. Again- where is the animal efficacy data? They must have it. Everyone else has shown this. If someone was buying, they would have already bought it. Certainly cheap enough here.
What kind of rodent “efficacy” data would you want to see?
This thread is a red herring, IMHO.
Yes, rodent PK has been shown. But why not the efficacy? If I had a dime for every drug that had good absorption and tissue distribution I would be a rich man.
What kind? The same kind Pardes and Shionogi have shown.
Thanks for the thoughtful reply. Indeed HCV had a great outcome. This was realized in a collab with Abbvie, not solo. Completely different game now. Others, including Shionogi and Pardes, have shown rodent efficacy data. Why none from Enanta? Also (as Dew expressed earlier) it is strange that they are running a Phase 2 and not a 2/3 registrational trial. To boot, safety is the primary endpoint! They are setting up for a “positive” P2 result no matter what (standard risk patients), by doing this.
That's trials. : ) Each step you only get a little more clear view of safety, efficacy. If there were animal studies posted you can still correctly assert that it's no proof it will work on people.
Years ago Gilead bought a whole company just to acquire rights to a Hep C drug; a nuke. They hypothesized that another company was having good results in trials using 4 antivirals to treat Hep C. Gilead thought; lets combine the nuke with another competitors drug; an NS5a antiviral - Daclatasvir.
Gilead thought that the nuke and NS5a in combination could work as well as the other HCV pioneering partnership's treatment- Abbott (now Abbvie) and Enanta's. (that was about 2010 or 11)
Gilead paid about 11 billion for the compound and the reaction was similar to yours; it's too much money and it's not proven. I was in that final Phase 3 registration study in 2014 where Gilead was still proving dosing and duration in the middle of the decade. Conventional wisdom was that Gilead had lost it's mind and overpaid........ and was soon proven soundly incorrect.
In the case of Enanta, it was some unknown tiny company, but it did what JNJ, Merck, BMY, Roche, Sherring-Plough, Boehringer Ingelheim, et al couldn't do.
AND Enanta did it twice, in two successful launches of Hep C treatments.
There was a time that conventional wisdom said that a "nuke was necessary" to treat Hep C. And yet this small company in a partnership w/ Abbvie created a pan-genotypic Hep C 2 drug treatment with protease inhibitors they created in each - without the use of a nuke.
How many companies tried to create a Covid antiviral? Who will have the best? That same small company seems to have some of the best data I've seen. Yes, it's still early and things are not yet proven to your satisfaction. We won't have that long to wait for data.
Enanta has demonstrated *proficiency* with protease inhibitors with great success in the past.
ENTA’s updated corporate slide set (11/21/22):
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
They have not released any animal efficacy data (as others have). Go ahead and link to the data since you say they have released it. All we have seen is cellular potency.
“Caveat Emptor”
How do you know it removes coronavirus infection in patients? Cellular potency data?
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