Aicuris Pritelivir (AIC-316) Updates

[JustHanginginThere]

We all know this drug was even better than the other HPI ASP2151 by the way it blew away Valtex in trials. Thie Phase 2 trial getting suspended due to the megadose causing adverse effects in animals was the biggest disappointment in HSV research lately.

I found a few updates online (shown on pharma licensing sites)--one said they are in preclinicals for a topical formulation in Germany and another that they are working on Phase 2 further development for the oral drug. 

Does anyone from the original trials that still keeps in touch with the investigators know what is happening? Can you find out? Taking this drug on a regular basis is supposed to make it feel like you don't even have herpes-a normal life--few to no outbreaks and very reduced shedding. I want to believe there is still hope for this drug and it will come back after reformulation.

Edited October 9, 2015 by JustHanginginThere

[Herbfresh]

It's dead dawg. Ain't happening. It was reducing shedding by 90%. The reality is pharma has a lot of power, more than you would realise. And they are not ready to give up their cash cows, the shitty other anti virals. 

I doubt it ever comes out in any form, but could be wrong. Perhaps in a few decades. This is how it goes with many drugs, they just put it on ice, with the intention of perhaps letting it out of the bag a few decades or more down the line. 

Topical formulation won't work. Topical versions of other anti virals prove this. 

[elnino]

On 10/8/2015, 8:38:10, JustHanginginThere said:

We all know this drug was even better than the other HPI ASP2151 by the way it blew away Valtex in trials. Thie Phase 2 trial getting suspended due to the megadose causing adverse effects in animals was the biggest disappointment in HSV research lately.

I found a few updates online (shown on pharma licensing sites)--one said they are in preclinicals for a topical formulation in Germany and another that they are working on Phase 2 further development for the oral drug. 

Does anyone from the original trials that still keeps in touch with the investigators know what is happening? Can you find out? Taking this drug on a regular basis is supposed to make it feel like you don't even have herpes-a normal life--few to no outbreaks and very reduced shedding. I want to believe there is still hope for this drug and it will come back after reformulation.

Hi, did you see my recent thread in the Cure Research forum? Check it out. I found something interesting related to AIC316. Not sure what to make of it.

[Sillybrain2]

39 minutes ago, elnino said:

Hi, did you see my recent thread in the Cure Research forum? Check it out. I found something interesting related to AIC316. Not sure what to make of it.

@elnino any word yet?

[elnino]

@Sillybrain2 No, no response to the emails I sent. I found another email for Aicuris today and send an email to that one.

I also found another site, updated in 2015, suggesting that this drug is not shelved: 

http://adisinsight.springer.com/drugs/800014422

Additionally, AiCuris R&D section still shows the drug as completed Phase II:

http://www.aicuris.com/29/Research-Development/R-D-Pipeline.htm

I'm very intrigued now. 

 

[Sillybrain2]

Curious-er and curious-er @elnino I like your investigative skills

[JustHanginginThere]

This is definitely dead and they never respond. My hopes are on Asp2151 in Japan.

[Mellisuga]

I just ran into an article about this thing and had been surprised that I've only heard about it now!

Article: http://www.medpagetoday.com/InfectiousDisease/STDs/43829

 

So...based on what you guys are all saying - it's dead? Seriously? Is there more information on what happened?

[waiting_on_a_sign]

On 3/29/2016 at 5:41 PM, Mellisuga said:

I just ran into an article about this thing and had been surprised that I've only heard about it now!

Article: http://www.medpagetoday.com/InfectiousDisease/STDs/43829

 

So...based on what you guys are all saying - it's dead? Seriously? Is there more information on what happened?

What was listed in the article you posted is basically all that anyone knows about what happened.

AiCuris released only several days ago that a topical form of AIC316 is in phase I trials, with the focus being HSV-1 and labial infections.

The release does make two references to oral Pritelivir:

Quote

“The pritelivir program with oral and topical treatment options will potentially open a whole HSV market to AiCuris and will help to address significant unmet medical needs.”

Quote

Currently the Company runs two clinical development programs with pritelivir. The most advanced, pritelivir (oral), showed superiority against standard treatment valacyclovir in a clinical phase 2 trial.

So, it seems that they consider the oral program still alive in their view. They also tend to reference the phase II oral trial as complete (eg. the chart on their R&D pipeline page) while also calling it "in phase II" rather than completed, but that just might be how they word things - they completed one phase II trial that established the optimal effective dose and compared its effectiveness to a placebo, and were forced to suspend a second phase II trial that compared its effectiveness to Valacyclovir, where the results were reportedly very good. I think they could push that sort of research to the phase III trial.

Regardless, I think it will be a while before anything comes of it. They're likely going the topical route to keep momentum in the project, get some sort of established approval of the drug from the FDA in some context, and use that to help find a licensee for the drug in general, in both forms, as it seems no one is interested in licensing a drug being held up by the FDA as that will require time and money for them to help navigate their bureaucracy. AIC316 also is the only unlicensed drug in development not in the list of partnering opportunities, which is somewhat strange, while some sites say "Aicuris is looking to partner global rights before running phase 3 trial".

Edited April 10, 2016 by waiting_on_a_sign

[@lw@ys]

Here's and update:

PRITELIVIR IS NOT DEAD

[Peeved]

I read that they recently completed a trial where they used patches on the skin instead of oral tablets. This was probably their way of getting around the issue that stopped their last trial. Hopefully it can be just as effective and get past the FDA

[@lw@ys]

30 minutes ago, Peeved said:

I read that they recently completed a trial where they used patches on the skin instead of oral tablets. This was probably their way of getting around the issue that stopped their last trial. Hopefully it can be just as effective and get past the FDA

Did you read the article by any chance? They tested the oral version for efficacy and resistance, the article was last updated June 23 of this year. They are currently developing the oral and the results are from a completed Phase II trial.

Edited July 31, 2016 by @lw@ys

[oneday]

Update of Pritelivir-Aicuris complete phase I topical trial, let's hope oral formulation, which reached Phase II goes on to Phase III. 

http://labiotech.eu/pritelivir-aicuris-germany-herpes/

[Gothic Beauty]

Yea, but... this is in Germany. How does that help us here in the USA?

[LucyLevi]

Hopefully if it comes out in one country it will get licenced for use in other places too? I think the main thing is that someone somewhere develops the capability as that's the starting place. 

Can someone just clarify for me: Is this for use for HSV1 initially?  If so will that be both oral and genital?

Thanks

Lucy 

[dont quit!]

On 8/24/2016 at 6:28 PM, oneday said:

Update of Pritelivir-Aicuris complete phase I topical trial, let's hope oral formulation, which reached Phase II goes on to Phase III. 

http://labiotech.eu/pritelivir-aicuris-germany-herpes/

They article didn't post effectiveness of ointment. If the Pritelivir oral med was out; that along with Halfords prophylactic vaccine should do the trick to decrease spread by a lot.

[Voyager2]

The 75mg daily dose of the original pritelivir led to an 87% reduction in the relative risk of viral shedding, which would likely curb the spread of HSV, especially if combined with Acyclovir. The reason they put the program on hold was because they gave monkeys 70 TIMES this daily dosage and the monkeys had skin problems. But who is going to take 70 times the normal amount?

If they are now continuing with pritelivir development, they should at least mention that the "snag" was reconciled. Why keep everybody in the dark? 

If not interrupted, we could have used Pritelivir for a few years, then switched to a more advanced therapeutic vaccine or drug in a few more years.

Maybe this story will have a happy ending after all.

Edited August 28, 2016 by Voyager2

[edcoop]

7 hours ago, Voyager2 said:

The 75mg daily dose of the original pritelivir led to an 87% reduction in the relative risk of viral shedding, which would likely curb the spread of HSV, especially if combined with Acyclovir. The reason they put the program on hold was because they gave monkeys 70 TIMES this daily dosage and the monkeys had skin problems. But who is going to take 70 times the normal amount?

If they are now continuing with pritelivir development, they should at least mention that the "snag" was reconciled. Why keep everybody in the dark? 

If not interrupted, we could have used Pritelivir for a few years, then switched to a more advanced therapeutic vaccine or drug in a few more years.

Maybe this story will have a happy ending after all.

This very same drug finished phase 3 in Japan rite ? Any mates from japan here who had a chance to participate in the trial and can share the experience? 

[dont quit!]

1 hour ago, edcoop said:

This very same drug finished phase 3 in Japan rite ? Any mates from japan here who had a chance to participate in the trial and can share the experience? 

It's in the same class but not the same drug. I believe it's called Amenamevir. The problem is, is that the Japanese Company-Maruho (I think that's company name), isn't releasing efficacy of drug or any further details i.e. release date, etc etc. But I think most infected folks are curious of results especially since Pritelivir seemed to have so much potential.

[hopeful Rylee]

I thought this drug was booted out of clinical trials.,,

[Maybe1day]

On 7/27/2016 at 10:16 PM, @lw@ys said:

Here's and update:

PRITELIVIR IS NOT DEAD

I read the article and it all sounds promising, but what's keeping it from making it to shelves? Is the article even from a reliable source? Website seemed of little to no legitimacy. 

[Second_chance]

14 hours ago, Maybe1day said:

I read the article and it all sounds promising, but what's keeping it from making it to shelves? Is the article even from a reliable source? Website seemed of little to no legitimacy. 

So would Pritelivir work more as a suppressor rather than a cure? 

[edcoop]

@second_chance, this is more of a suppresent than a "cure".

Its supposedly better than current crop of.meds - varients of Acyclovir - at inhibiting the viruses to multiply thus reducing the days u shed virus and OBs. whatever i said is in layman's terms and I am no way qualified (no way near that smart) to answer in scientific way..

[@lw@ys]

On ‎8‎/‎28‎/‎2016 at 6:48 PM, Maybe1day said:

I read the article and it all sounds promising, but what's keeping it from making it to shelves? Is the article even from a reliable source? Website seemed of little to no legitimacy. 

It's moving on the Phase III, also the Aicuris website also has the latest info that supports articles of this type. There was a post on this site awhile back from someone that participated in the Phase II study and stated that it was like not having HSV. Again, not a cure but I could live with that feeling until there is

[oneday]

Where does it say it's moving to phase III?