Marugo - Amenalief

[MikeHerp]

This was already posted earlier.

But I just wanted to emphasize, this is pretty good news. 

https://www.maruho.co.jp/english/release/nek5p400000055oj-att/20190909_pr_eng.pdf

Hopefully this will be a continuation of the work they previously undertook.  So a path to regulatory approval, would be shortened.

This would also hopefully mean, cheaper meds.

[Kurdt01]

Any educated guess what the timeline might be for this to be available in the US? I keep waiting on the price to drop from the Japanese site...

[Kurdt01]

At the very least it looks like we may all have some new treatment options within a couple years...that would be life changing for many of us...

[MJRX]

This for sure is great news, I hope due to this that the prices will drop. Since I am planning to start using it in the near future.

I also hope that any of the meds will be available in the EU anytime soon when it is approved by the FDA.

Does anyone know if a FDA approval is also counting for the West-EU?

[Mikeike3]

price has dropped - 475-510 shipped

[dont quit!17]

14 minutes ago, Mikeike3 said:

price has dropped - 475-510 shipped

have you tried med?

[MikeHerp]

32 minutes ago, Mikeike3 said:

price has dropped - 475-510 shipped

It looks like the same price as around a year ago.  

Edited October 15, 2019 by MikeHerp

[MikeHerp]

9 hours ago, Kurdt01 said:

Any educated guess what the timeline might be for this to be available in the US? I keep waiting on the price to drop from the Japanese site...

I'm not sure.  I had a feeling that it had been in the process of a phase 2 in the US.  But hopefully somebody can check whether that is actually the case.  I don't remember whether the phase 2 was finished or not.  

[WilsoInAus]

31 minutes ago, MikeHerp said:

I'm not sure.  I had a feeling that it had been in the process of a phase 2 in the US.  But hopefully somebody can check whether that is actually the case.  I don't remember whether the phase 2 was finished or not.  

No, phase 2 was not successfully navigated.

An IND application needs to be made before the clinical trials commence. The Pre-IND meeting doesn’t mean the trials have been approved, it’s just a chance to receive feedback from the FDA regarding the drug and the plans for the trials.

Next step is for submission of the IND.

 

[MikeHerp]

Trials were previously approved and phase 2 was completed in the US.

https://clinicaltrials.gov/ct2/show/NCT00486200

https://www.ncbi.nlm.nih.gov/pubmed/22351940

https://adisinsight.springer.com/drugs/800025919

Alternative Names: Amenalief; ASP-2151; M-5220

[WilsoInAus]

21 minutes ago, MikeHerp said:

Trials were previously approved and phase 2 was completed in the US.

https://clinicaltrials.gov/ct2/show/NCT00486200

https://www.ncbi.nlm.nih.gov/pubmed/22351940

https://adisinsight.springer.com/drugs/800025919

Alternative Names: Amenalief; ASP-2151; M-5220

That’s the Atellas trials not related this company’s application.

Astellas is a whole other story.

[MikeHerp]

This is a drug that was licensed by Astellas to Maruho.  Of course, Maruho can piggyback on previous trial results by Astellas in the US.  It's the same drug dude.  

That's why they are talking about phase 3 now, not phase 1.

 

 

[MikeHerp]

https://adisinsight.springer.com/drugs/800025919

Amenamevir - Maruho

Alternative Names: Amenalief; ASP-2151; M-5220

• Originator: Astellas Pharma
• Developer: Astellas Pharma; Maruho

[WilsoInAus]

9 minutes ago, MikeHerp said:

This is a drug that was licensed by Astellas to Maruho.  Of course, Maruho can piggyback on previous trial results by Astellas in the US.  It's the same drug dude.  

That's why they are talking about phase 3 now, not phase 1.

 

 

I’m not sure about that, Astellas has been suspended.

Either way, a Phase 2 has to be completed.

[MikeHerp]

2 minutes ago, WilsoInAus said:

I’m not sure about that, Astellas has been suspended.

Either way, a Phase 2 has to be completed.

https://clinicaltrials.gov/ct2/show/NCT00486200

https://www.ncbi.nlm.nih.gov/pubmed/22351940

Condition or disease	Intervention/treatment	Phase
Herpes Genitalis	Drug: ASP2151Drug: valacyclovirDrug: Placebo	Phase 2

Actual Enrollment  :

695 participants

Actual Study Start Date  :	June 21, 2007
Actual Primary Completion Date  :	August 12, 2008
Actual Study Completion Date  :	August 12, 2008

RESULTS:

Of 695 adults enrolled, 437 experienced a recurrence and received study drug. Median time for lesion healing excluding aborted lesions was 139.8 hours with placebo, 119.6 hours with ASP2151 (100 mg; hazard ratio

---

, 1.40; P = .065), 106.2 with ASP2151 (200 mg; HR, 1.40; P = .081), 115.9 with ASP2151 (400 mg; HR, 1.25; P = .25), 102.1 with ASP2151 (1200 mg; HR, 1.72; P = .007), and 113.9 with valacyclovir (500 mg twice daily; HR, 1.42; P = .077), indicating improvement in all treatment groups except ASP2151 (400 mg). Incidence of treatment-emergent adverse events was similar across groups.

CONCLUSIONS:

Three-day or single-day courses of ASP2151 appear to be effective and safe options for treatment of episodes of recurrent genital herpes.

[WilsoInAus]

@MikeHerp way off piste, lets get back to the comments I have made.

In the eyes of the FDA, a phase 2 trial has to be completed. It’s in the press release.

The drug had previously failed safety in Phase 3 which I suspect invalidates the previous Phase 2 trials. Clearly doing the phase 2 trial again is intended to allay the safety concerns.

[MikeHerp]

A phase 2 has already been completed dude.  

I've linked to it 3 times in this thread already lol.  All you have to do is point your cursor over this link, and then click your mouse button.  

Do you have a mouse in your computer?  Does the mouse button work?  

The phase 2 in the press release is an "exploratory study".  It's probably for a different indication.  Maybe for suppression.  Who knows.  The bottom line is that, a phase 2 was completed, and the results were published already.

 

 

 

[WilsoInAus]

45 minutes ago, MikeHerp said:

A phase 2 has already been completed dude.  

I've linked to it 3 times in this thread already lol.  All you have to do is point your cursor over this link, and then click your mouse button.  

Do you have a mouse in your computer?  Does the mouse button work?  

The phase 2 in the press release is an "exploratory study".  It's probably for a different indication.  Maybe for suppression.  Who knows.  The bottom line is that, a phase 2 was completed, and the results were published already.

 

 

 

No one’s denying that. The failure of the phase 3 study probably requires the phase 2 study.

They are doing a phase 2 study, simplex.

[MikeHerp]

Huh?  lol.  

Again, phase 2 was already completed.  So it's not required.  It's been done.  

"CONCLUSIONS:  Three-day or single-day courses of ASP2151 appear to be effective and safe options for treatment of episodes of recurrent genital herpes."

 

[WilsoInAus]

1 minute ago, MikeHerp said:

Huh?  lol.  

Again, phase 2 was already completed.  So it's not required.  It's been done.  

"CONCLUSIONS:  Three-day or single-day courses of ASP2151 appear to be effective and safe options for treatment of episodes of recurrent genital herpes."

 

And subsequent to that they failed a Phase 3 on the basis of safety. Back to phase 2 to move forward safely.

[MikeHerp]

You're just making shi* up again.  

Phase 2 was already completed.  Phase 2 already showed safety.  So showing safety through phase 2, would be redundant.

FDA has already approved the plan for phase 3, which would be difficult if there was no completed phase 2.  Phase 2 data is critical to approving the plan for a phase 3 trial.  

It's clear you had no knowledge about this drug or the licensing to Maruho, or that it was already tested in the US. 

 

[Kurdt01]

Lets just hope maybe we see this and Pritelivir by 2021...I'll only be 42.....so glad to get my life back with time to spare.

[WilsoInAus]

1 hour ago, MikeHerp said:

You're just making shi* up again.  

Phase 2 was already completed.  Phase 2 already showed safety.  So showing safety through phase 2, would be redundant.

FDA has already approved the plan for phase 3, which would be difficult if there was no completed phase 2.  Phase 2 data is critical to approving the plan for a phase 3 trial.  

It's clear you had no knowledge about this drug or the licensing to Maruho, or that it was already tested in the US. 

 

The FDA have not approved anything, where does the press release say approved?

A pre-IND meeting is to gain feedback only, it is not part of the approval process, nor compulsory.

I feel the press release is clear enough, but lets wait to see the trials filed as part of the actual IND shall we.

[MikeHerp]

It says the plan for phase 3 was accepted by the FDA.  

[WilsoInAus]

8 minutes ago, MikeHerp said:

It says the plan for phase 3 was accepted by the FDA.  

Exactly what I said.

the “development plan” for phase 2 and phase 3 was “accepted”.

There is no approval element to a pre-IND meeting.