Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Thank you, Randy.
From the company - direct -
Enanta Pharmaceuticals Announces Positive Topline Results for EDP-323 in a Phase 2a Human Challenge Study of Healthy Adults Infected With Respiratory Syncytial Virus (RSV)
Sep 26, 2024
Treatment With Once-Daily EDP-323 Met Primary and Secondary Endpoints, Achieving Highly Statistically Significant Reductions in Both Viral Load and Clinical Symptoms Compared to Placebo
Favorable Safety and Tolerability Observed
Conference Call and Webcast to Discuss Data at 8:30 a.m. ET Today
WATERTOWN, Mass.--(BUSINESS WIRE)--Sep. 26, 2024-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating best-in-class small molecule drugs for virology and immunology indications, today announced positive topline results from a Phase 2a human challenge study of EDP-323 in healthy adults infected with respiratory syncytial virus (RSV). These data demonstrated that EDP-323 was generally safe and well-tolerated and achieved an 85-87% reduction in viral load area under the curve (AUC) by qRT-PCR (p<0.0001), a 97-98% reduction in infectious viral load AUC by viral culture (p<0.0001), and a 66-78% reduction of total clinical symptoms score AUC (p<0.0001) compared to placebo. EDP-323, which received Fast Track designation from the U.S. Food and Drug Administration (FDA), is a novel L-protein inhibitor in development as a once-daily oral treatment for RSV.
“We are excited about these impressive data that demonstrate a rapid and sustained reduction in viral load. These results are among the strongest ever reported in an RSV challenge study, raising the high bar set by zelicapavir. The significant antiviral activity and symptom alleviation observed in this study highlight EDP-323’s potential as a safe, highly effective, direct-acting antiviral for the treatment of RSV,” said Scott T. Rottinghaus, M.D., Chief Medical Officer of Enanta Pharmaceuticals.
“These EDP-323 results represent a meaningful advancement toward achieving our longstanding goal of developing new medicines to treat respiratory infections such as RSV, as there remains a substantial need for safe and effective oral treatments. Enanta has the leading portfolio of potent RSV replication inhibitors, with EDP-323, our L-protein inhibitor, and zelicapavir, our N-protein inhibitor, both in Phase 2 development. These distinct mechanisms have the potential to be developed as once-daily single agents or in combination for specific patient populations,” added Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals.
EDP-323 Phase 2a Challenge Study Topline Results
This Phase 2a study was a randomized, double-blind, placebo-controlled, human challenge study of 142 healthy adult participants inoculated with RSV. Randomized participants (n=141) received either a once-daily (QD) 600 mg dose of EDP-323 for five days [high dose, n=47], a single 600 mg loading dose on day one followed by a 200 mg once-daily (QD) dose of EDP-323 for four days [low dose, n=47], or placebo for five days [n=47]. The intent-to-treat-infected population (ITT-I) was defined as all randomized participants receiving challenge virus and at least one dose of study drug with confirmed RSV infection.
EDP-323 demonstrated a rapid and sustained antiviral effect. A highly statistically significant reduction (p<0.0001) was observed for the primary efficacy endpoint of AUC for viral load as measured by qRT-PCR in the ITT-I population for each of the EDP-323 dosing groups as compared with placebo. Specifically, EDP-323 lowered viral load AUC by 85% in the high dose arm and 87% in the low dose arm compared to placebo. There was no statistically significant difference between the two EDP-323 dosing groups.
A highly statistically significant reduction (p<0.0001) was observed for the secondary efficacy endpoint of AUC for infectious viral load as measured by quantitative culture in the ITT-I population for each of the EDP-323 dosing groups, with a reduction in viral culture AUC by 98% in the high dose arm and 97% in the low dose arm compared to placebo. There was no statistically significant difference between the two EDP-323 dosing groups.
For the secondary efficacy endpoint of AUC for total symptom score, a highly statistically significant reduction (p<0.0001) was observed in the ITT-I population for each of the EDP-323 dosing groups, with a symptom reduction of 66% in the high dose arm and 78% in the low dose arm compared to placebo. There was no statistically significant difference between the two EDP-323 dosing groups.
EDP-323 demonstrated favorable pharmacokinetics, supportive of once-daily dosing. Mean trough plasma concentrations were maintained at 16-fold above the protein-adjusted EC90 with the low dose, and 35-fold above the protein-adjusted EC90 with the high dose, for both RSV A and B strains.
Overall, EDP-323 demonstrated a favorable safety profile over a 5-day dosing period and through 28 days of follow-up. Adverse events were similar between EDP-323 dosing groups and placebo. There were no serious adverse events, no severe adverse events, and no adverse events leading to treatment discontinuation or study withdrawal.
Full data from the study will be presented at a future medical conference or in a peer-reviewed publication.
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at 8:30 a.m. ET. The live webcast can be accessed at "Events & Presentations" in the investors section of Enanta’s website. To participate by phone, please register for the call here. It is recommended that participants register a minimum of 15 minutes before the call. Once registered, participants will receive an email with the dial-in information. The archived webcast will be available on Enanta’s website for approximately 30 days following the event.
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-positive-topline-results-edp
The price trend has not been friendly lately. Anyone adding here? 🚀
Both CLDX and ENTA are seeking an immunological solution for Chronic Spontaneous Urticaria, to my understanding.
Thanks, somehow I thought ENTA's new candidate is targeting the same condition?
looks like CLDX recovered quite a bit - ended up down 12%
I have to think the cc and subsequent conversations with management allayed some investor concerns
I doubt that CLDX's data had a material affect on ENTA's share price today.
So I guess ENTA was up and down because the result was good enough (71% of patients (150 mg Q4W) achieved complete response at Week 52) but also not good enough in a sense (8-13% AE vs 4%) vs the baseline?
CLDX—(-20%)—reports phase-2 CSU data_for barzolvolimab—25%_dropout_rate_and hair-color changes_in_6_patients:
https://finance.yahoo.com/news/celldex-therapeutics-presents-landmark-52-144500144.html
CC slides (slide #6 contains AE info):
https://ir.celldex.com/static-files/104cb8ec-550b-42d3-aef6-3c9d9c9d9fdb
In most cases where a court issues a judgment of patent infringement, the royalty on past sales applies to future sales, until patent expiration.
The drawback would be increased spend because it wouldn't be instead of the 938 phase 3 assuming good data but in addition otherwise you delay bringing any drug to market
Reviral essentially just had challenge data when they were bought and the peds phase 2 was terminated shortly thereafter. I do think PFE could be a potential partner Reviral had an N inhibitor preclinical similar to 938 that was then shelved
also from RBC (last report before they discountined coverage)
Potential upside for shares could come from a patent infringement suit with PFE, though this
will take some time and battling PFE’s legal team will likely continue to be difficult. Recall
that ENTA had sued PFE, claiming that Paxlovid had infringed upon ENTA’s ’953 patent, with an
argument that our KOL thought had some merit. However, so far, the Court has ruled in favor of
PFE in the Markman hearing and compelled ENTA to supplement its infringement theory, both
of which we believed to be potential setbacks for ENTA. The latest timeline indicates that fact
discovery will close on November 17, 2023, expert depositions will be completed by April 22,
2024, and the trial is expected to get under way by mid-2024 (with a May 10, 2024 deadline
for Daubert motions). We believe that given the current COVID-19 dynamics, any potential outyear Paxlovid royalty value from a lawsuit victory would also be somewhat diminished; while we
believe a win for ENTA would be worth as much as $7/share and maintains upside optionality
for shares in the face of ENTA’s internal pipeline challenges, it will likely take some time to play
out, and given initial developments, we see it as relatively low likelihood.
From my July 27, 2024 post -
FWIW -
It still is a big IF that ENTA wins summary judgment against PFIZER. Even a mediated settlement is quite positive.
Back in June of 2022, RBC Capital Markets analyst Brian Abrahams states -
"A typical royalty rate might be in the 6% range, which on sales of Paxlovid's magnitude, could be more than $1 billion annually in its peak years and may speak to why it might be worth Enanta's time and expenses to pursue this," he said in a report to clients.
https://www.investors.com/news/technology/enta-stock-launches-as-enanta-causes-a-kerfuffle-for-pfizer-paxlovid/
What would be the drawback of pushing for a combo trial? How likely the combo would be worse than single trial given the 938 and 323 have different mechanics?
Also how is the current status of ENTA RSV programme compared to ReVirals a year or two ago?
I think back then ENTA didn’t have the infants data?
You think PFE would be interested to partner with Enta on RSV for competitive reason?
Ok but I would think there isn’t that much to say until 938 data are out. If the 938 data are robust there may not be much of a need to progress 323 although the company has alluded to possible combination for the rare difficult / severe case. The other relevant data to know before making a decision on 323 is the challenge study results from Shionogi which is also not due until Q4. If the company is compelled to move both drugs forward (for competitive reasons as much as anything) I hope they partner the assets.
In the 3% royalty scenario, would the 3% be applied to future sales as well?
Re: Paxlovid settlement estimate
Let's estimate what ENTA would be due from PFE if ENTA prevailed in a trial. Including PFE's guidance for 2024, PFE will have sold about $12B of Paxlovid in the US market from product inception (Dec 2021) to 12/31/24. Let's apply a 3% royalty rate, which is pretty conservative for a patent-infringement case. Then the cumulative royalties due to ENTA would be (0.03)($12B) = $360M, plus interest.
(If the court found PFE to be guilty of willfull infringement, it could award ENTA treble damages, or about $1B plus interest. However, few patent-infringement suits result in treble damages, so this outcome is a longshot.)
If a win at trial would result in an award to ENTA of $360M plus interest, a settlement of $150M to ENTA (the estimate you cited from a sell-side analyst) seems like a lower bound. A settlement of $200-250M is more likely, IMO.
alert, you ask questions which are impossible to answer. Suggest you wait till after the chickens are hatched, before counting ‘em. Best wishes.
Paxlovid patent lawsuit
Any estimate on what a settlement would look like if it happens?
iIRC, rbc estimates about 5 bucks per share or about 150mm, is that low?
I dunno… as dewophile messaged earlier, a disappointing 323 trial may actually cause the stock to move higher, given a possible reduction in p3 trial costs going forward
Hope they can conclude this chapter sooner rather than later, especially if it’s a moon shoot, they are spending quite a bit of SG&A on this.
I guess can be very rewarding if they do see a good chance on getting a settlement or favourable ruling on this.
Market cap is 230mm, a 200mm settlement payment will double the shares
And I think we can potentially see a much larger sum, only PFE and ENTA know better
I would think a positive challenge study results would at least help convince the market that the RSV pipeline is not a negative asset.
ENTA committed to having a CC for the EDP-323 "challenge" study results. This info is in the 8/5/24 PR announcing the FY3Q24 results (#msg-174869263).
I have no clue if there will be a call along with the challenge study results, but I do want to remind you that several drugs have had positive challenge study results and failed real world trials, so again I just don't think the Q3 release is market moving
There are motions in front of the judge to dismiss the case or settle the matter without trial, but if the case proceeds to trial enanta has said the timing should be around year end
When will we get an update on the patent case?
Is it going to full trial soon? Or it will be ruled without trial?
I guess both sides will appeal unless they have a settlement
Ie this will drag on for a while, correct?
We were told end of 3rd quarter, so on or before 30 September. Since they are going to have a call, I expect to hear an announcement of the call this week. ENTA, it’s time to go UP!
So we have 4 business days left in Sept... do you guys think we will see the data by end of Sept or will be slip to early Oct?
Volume heavy again. Seems some funds liquidating recently after the run up
Hopefully done soon
I bought all I wanted higher
Sigh
New QT study posted for zelicapavir (938)
https://clinicaltrials.gov/study/NCT06601192?term=Edp-938&page=1&rank=2
It looks like a brokered trade to move volume without unduly affecting share price
Company update soon… The company will provide its next update with the release of the EDP-323 challenge study results, expected in late third quarter of 2024.
Weird indeed. The couple reports I read didnt give much odd for enta to win the case. Why would a law firm make it a showcase?
I guess any exposure is good exposure?
Flo, I too noticed the large Market on Close trade. I do not fully understand the logic on these trades. Perhaps others will opine.
lol, pretty sure we will get there at least one more time.
This management team delivers
Weird to highlight a case that is still pending. You would think they would only bring attention to cases with a favorable outcome.
Huge volume in after-market with one trade (no change) -
TIME. PRICE. #SHARES
16:00:06.............$11.3...................426,561
Foley Hoag Recognized as 2024 Law360 "Regional Powerhouse" in Massachusetts
September 19, 2024
Law360 again recognized Foley Hoag LLP as a “Regional Powerhouse” in Massachusetts. The law firms on Law360’s list of 2024 Regional Powerhouses are driving some of the biggest deals and most high-profile courtroom battles, delivering top-tier regional expertise for clients and making a lasting impact on the law at the state and local level.
The Regional Powerhouses Series honors leading law firms in various states based on their exceptional achievements. In Massachusetts, Law360 recognized only three firms, including Foley Hoag. Law360 noted, “With some of the state's household-name clients under its belt and a former Massachusetts attorney general on its roster, Foley Hoag LLP is one of the state's premier law firms in a number of growing sectors.”
The recognition reflects the complex legal work performed for clients by Foley Hoag across cutting-edge industries, including life sciences, technology, energy and cannabis, and the results achieved. Law360 specifically highlighted the firm’s representations of:
Enanta Pharmaceuticals in a patent litigation involving Pfizer's antiviral COVID treatment Paxlovid.
https://www.foleyhoag.com/news-and-insights/news/2024/september/foley-hoag-recognized-as-2024-law360-regional-powerhouse-in-massachusetts/
The "proof is in the pudding". Let's hope Hoag representation will be positive for ENTA.
Again, representing the Plaintiff, Enanta:
https://foleyhoag.com/people/fiacco-barbara/
🤗 See ya at $18 alert!
I am probably the one who needed more analysis
Either way, it’s cheap enough for me to get in just in case, some settlement , buyout or partnership news hit the wire.
I think my downside is protected nicely by cash and royalty value at this level
alert… ENTA was within pennies of yesterday’s low on 14 Aug and 6 Sep and we didn’t move straight to $18. I agree technical analysis is a tool, but as a predictor it often fails. Perhaps I need more analytical skills 🙃.
The last two times ENTA reached this level, it managed to bounce all the way back to 17 18
Will be interesting to see what happen in new couple months
references for ark bio peds data
(and apologies for typos in the post I am responding to I was mobile and dictating)
phase 2 data set from Ark bio's fusion inhibitor (N=80, 73 completed trial, N=49 for randomized part of trial with 3 dose levels tested so overall N in the go forward dose for phase 3 quite small so data will have a lot of noise):
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10368966/
PR on the phase 3 data with N=300 and change:
https://arkbiosciences.com/en_2022n/112
Thanks dewophile…
Hard to say because there is a paucity of data in this setting amd it’s a small trial that is not powered on synptoms and other clinical endpoints. If they get a log delta and trend on any clinical endpoints that’s good. Less than half a log not good. The ark bio chinese trial had .6 log and got on clonical endponts in phase 3 but only had robust effects in the youngest age groups IIRC. those of the rough benchmarks I have in my head but the arc biodata is a different mechanism of action also and otherwise there’s really nothing else to go on as a frame of reference as far as I know
Understand… What's the definition of ‘meh data’? I can guess but rather hear from u…
Yes, the ‘planning for success’ comment caught my attention also. One can tell Tara is talented in her work and in communicating her thoughts. She has a deliberate speaking style and she chooses words to allow a broad audience to understand her message. Also Cantor’s rep asked excellent questions in a thoughtful manner.
Followers
|
97
|
Posters
|
|
Posts (Today)
|
3
|
Posts (Total)
|
3235
|
Created
|
03/20/13
|
Type
|
Free
|
Moderators DewDiligence |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |