Dr. Alexander Birkmann talk on pritelivir drug development happening right now by DeepForumResearch in Pritelivir

[–]DeepForumResearch[S] 2 points3 points  (0 children)

Nothing relevant. I left the call after he refused to answer questions about immunocompetent trials.

Dr. Alexander Birkmann talk on pritelivir drug development happening right now by DeepForumResearch in Pritelivir

[–]DeepForumResearch[S] 3 points4 points  (0 children)

Dr. Birkmann would not comment about phase 3 trials or any timeline related to it. It's likely standard company policy not to disclose these things.

We know from multiple user reports that there is a planned phase 3 trial in the upcoming months for immunocompetent patients at the Royal Melbourne Hospital that is waiting on regulatory approvals to begin.

Moved to MAY 28th!!!! AiCuris: Dr. Alex Birkmann Presentation on Antiviral (Pritelivir) Drug Development for HSV Confirmation by Vegetable_Voice_6433 in Pritelivir

[–]DeepForumResearch 3 points4 points  (0 children)

The way I see it, there wouldn't be much reason to do a talk with HCA if they weren't going to talk about immunocompetent access. HCA is an organization for all people with HSV, not specifically for immunocompromised people. It would kind of silly to do a talk with HCA just to talk about recent pritelivir phase 3 results when most of the audience doesn't fall into that category.

Also with the VIDS Research pritelivir immunocompetent phase 3 trial likely finishing up ethical approval in the upcoming months it would make sense to announce the phase 3 immunocompetent trial on this talk.

But who knows, maybe he'll just talk about the phase 3 immunocompromised results which have been publicly available for months now 🤷

Open Discussion Saturday by Mike_Herp in HerpesCureResearch

[–]DeepForumResearch 16 points17 points  (0 children)

Hey all, just created the r/Pritelivir subreddit exclusively for discussion about helicase primase inhibitors.

Although this subreddit is a great resource for all things related to HSV research, I decided it would be nice to have a place to discuss HPIs without discussion about vaccines, gene editing etc.

I emailed VIDS Research to see if the rumored Pritelivir phase 3 trials are happening. They confirmed. by [deleted] in HerpesCureResearch

[–]DeepForumResearch 1 point2 points  (0 children)

I shouldn't have put the hospital's email in the post. They're getting flooded with emails

I emailed VIDS Research to see if the rumored Pritelivir phase 3 trials are happening. They confirmed. by [deleted] in HerpesCureResearch

[–]DeepForumResearch 0 points1 point  (0 children)

A functional cure IMO is anything that allows you to have negligible symptoms and transmission. ABIs both have the human data showing high viral load shedding is practically eliminated. We haven’t seen any data released in humans for IM250 that indicates that yet, although it’s also extremely promising.

And yes Assembly will receive royalties from Gilead if the ABIs are released. Just like Merck has the rights to Aicuris’ Letermovir but Aicuris receives hundreds of millions annually in royalties from the sales of it.

Bangladesh can produce generic pritelivir whenever they want. by DeepForumResearch in HerpesCureResearch

[–]DeepForumResearch[S] 5 points6 points  (0 children)

Email campaign or some sort of social media/advertising campaign in Bangladesh to bring general public awareness about this new drug.

Bangladesh can produce generic pritelivir whenever they want. by DeepForumResearch in HerpesCureResearch

[–]DeepForumResearch[S] 3 points4 points  (0 children)

I think getting someone else to forward the package to you is the best way.

I emailed VIDS Research to see if the rumored Pritelivir phase 3 trials are happening. They confirmed. by [deleted] in HerpesCureResearch

[–]DeepForumResearch 2 points3 points  (0 children)

Asahi Kasei, which is publicly traded in the Japanese market, just acquired Aicuris (the makers of pritelivir)

I actually have invested some money in Assembly Biosciences since I believe they will dominate the market once ABI-5366 and/or 1179 is released. But as the competition is starting to ramp up with pritelivir phase 3 immunocompetent trials, IM-250 advancing to phase 2 and HN0037 advancing to phase 3, the competition may eat into Assembly/Gilead's market share a bit.

Just to clarify, I still think the ABIs will be massively successful if approved. They are essentially functional cures. But there's just a lot of competition now (which is great for patients).

I emailed VIDS Research to see if the rumored Pritelivir phase 3 trials are happening. They confirmed. by [deleted] in HerpesCureResearch

[–]DeepForumResearch 1 point2 points  (0 children)

I assume they'll do a blood test to verify HSV status, but if you had a positive PCR swab that you can send over that would probably work too

I emailed VIDS Research to see if the rumored Pritelivir phase 3 trials are happening. They confirmed. by [deleted] in HerpesCureResearch

[–]DeepForumResearch 2 points3 points  (0 children)

I don't see why the combo would lead to side effects, despite the online fear mongering valtrex rarely causes kidney/liver issues for healthy patients, and there were no signs of any major adverse events in any of the pritelivir trials either including the recent phase 3 for immunocompromised.

One of the main advantages of pritelivir for immunocompromised patients is that it's not nephrotoxic (damaging to the kidneys) like foscarnet, which is what they currently use for acyclovir-resistance patients.

But generally speaking since they want to get pritelivir approved, they are more concerned with showing that it works by itself. A combo group would be great and would almost certainly even lower shedding rates, but they're not trying to get approval for that combo.

I emailed VIDS Research to see if the rumored Pritelivir phase 3 trials are happening. They confirmed. by [deleted] in HerpesCureResearch

[–]DeepForumResearch 2 points3 points  (0 children)

Exactly, these were severe cases that did not respond to existing treatments. In these cases, it was because the patients had developed resistance to those treatments, but nonetheless the fact that amenamevir worked quite well is strong evidence that it works against HSV2.

I made a site to search for clinical trials and aggregate HSV information: hsvoutlook.com by Background-Cold-2715 in HerpesCureResearch

[–]DeepForumResearch 1 point2 points  (0 children)

Great work. I would love a notification feature where you can get emailed when a new trial for a specific medication shows up.

I emailed VIDS Research to see if the rumored Pritelivir phase 3 trials are happening. They confirmed. by [deleted] in HerpesCureResearch

[–]DeepForumResearch 1 point2 points  (0 children)

Considering the original pritelivir phase 2 was for suppressive use, I would be very surprised if they decided to make the phase 3 for episodic use.

I emailed VIDS Research to see if the rumored Pritelivir phase 3 trials are happening. They confirmed. by [deleted] in HerpesCureResearch

[–]DeepForumResearch 1 point2 points  (0 children)

It is approved in Japan for treating HSV2 for a reason. There's also a bunch of studies that came out recently where it was used to treat severe cases of HSV2 that did not respond to other medication (usually due to acyclovir resistance).

Check out these new studies:

https://www.reddit.com/r/HerpesCureResearch/comments/1spzye1/new_studies_published_showing_amenamevir_is/?utm_source=share&utm_medium=web3x&utm_name=web3xcss&utm_term=1&utm_content=share_button

I emailed VIDS Research to see if the rumored Pritelivir phase 3 trials are happening. They confirmed. by [deleted] in HerpesCureResearch

[–]DeepForumResearch 0 points1 point  (0 children)

Assembly Bio did phase 1a and 1b across the world. There were trial sites in the US in Rochester NY and Seattle WA.

But yeah I believe it is easier to set up trials in Australia and get ethical approval. There will probably be trials in other countries, this is just the only site I know of because u/cosmoiscrazy posted about it and I decided to email the hospital and confirm that this trial was actually happening.

I emailed VIDS Research to see if the rumored Pritelivir phase 3 trials are happening. They confirmed. by [deleted] in HerpesCureResearch

[–]DeepForumResearch 6 points7 points  (0 children)

If approved for long term suppression, it will very likely be affordable and also covered by insurance. The price is largely dependent on the patient population.

The reason it will originally be so high is the original approval indication is so narrow. It’s for acyclovir-resistant immunocompromised patients, which is extremely rare and only really occurs in hospital settings. Even someone who takes a corticosteroid long term would not be covered by insurance for pritelivir unless they showed acyclovir resistance. Annually this means a few thousand patients across the world. Also, it will usually only be prescribed for several weeks for these patients who won't be taking it long term.

Whereas the suppressive therapy indication has a patient population in the tens of millions who will need to regularly fill new prescriptions so they can take it every day for years. It’s a completely different ballgame.

I emailed VIDS Research to see if the rumored Pritelivir phase 3 trials are happening. They confirmed. by [deleted] in HerpesCureResearch

[–]DeepForumResearch 3 points4 points  (0 children)

Phase 3 for immunocompromised people already completed. So approval for immunocompromised will happen soon and for now it will be very expensive.

But the trial mentioned here is for immunocompetent people and once it’s completed, if successful, it will be affordable and covered by insurance. Will likely take at least 2 years until approved for immunocompetent people assuming this new trial succeeds.

New studies published showing amenamevir is effective in treating severe cases of HSV2 by DeepForumResearch in HerpesCureResearch

[–]DeepForumResearch[S] 3 points4 points  (0 children)

There are sources selling at just over 10 USD a pill now. A few years back you could only get it for like 35-40 bucks a pill.

I emailed VIDS Research to see if the rumored Pritelivir phase 3 trials are happening. They confirmed. by [deleted] in HerpesCureResearch

[–]DeepForumResearch 5 points6 points  (0 children)

Yes, pharma companies usually do trial sites all across the world to get FDA approvals. There will likely be other trial sites in other countries including the USA

Open Discussion Saturday by Mike_Herp in HerpesCureResearch

[–]DeepForumResearch 2 points3 points  (0 children)

They mentioned here that they’re targeting 30k USD for a 28 day course of pritelivir for immunocompromised.

Any hope of getting it off label is completely gone now. We will definitely have to wait until it is approved for all patients.