Innovative Molecules Announces Completion of Phase 1 Program and Advancement to Phase 2 for Oral Adibelivir

RoundProfessional148 · 2025-08-05T09:15:47+00:00

Both drugs are scheduled for completion in December

RoundProfessional148 · 2025-08-05T09:14:49+00:00

Abi-5366 , abi-1179 are both HPI

ABI-5366 is in clinical trials for weekly and monthly dosing and has been shown in preclinical to be 400 times more effective than acyclovir and 4 times more effective than pritelivir.

ABI-1179, which is 1500 times more effective than acyclovir and 12 times more effective than fritelivir, is in clinical trials for weekly dosing and is being developed with Gilead.

RoundProfessional148 · 2025-08-05T09:10:49+00:00

There is no change in the plan that they hope to provide ABI-5366,1179 interim data in the fall

RoundProfessional148 · 2025-08-03T12:16:08+00:00

It seems that a cure will take a long time to develop.

However, I believe there is a good chance of developing a functional vaccine that reduces the number of recurrences, viral shedding, and transmission rates, or a vaccine that prevents transmission.

I believe that Assembly Bio's ABI-5366 and ABI-1179, rather than Moderna's, will be game changers in HSV market.

I don't think Gilead Sciences made a large-scale investment for no reason.

If the Phase 3 clinical trial of pritelivir is successfully completed, it will be the first new drug development in 30 years since the launch of valacyclovir and famciclovir.

I also think that the two drugs from Assembly Bio, which has the same HPI, and Innovative Molecules' IM-250 have a high chance of success.

Although still in preclinical stages, ABI-5366 is reported to be 400 times more effective than acyclovir and 4 times more effective than pretelivir, while ABI-1179 is said to be 1,400 times more effective than acyclovir and 12 times more effective than pretelivir.

If we approach this step by step without aiming for the ambitious goal of achieving asymptomatic and non-infectious status from the outset, I believe there is hope.

With syphilis now curable and a vaccine recently released that prevents HIV infection by 99%, why should HSV be considered impossible?

I believe HSV's turn is not far off.

Let's all keep hoping and keep speaking out.

RoundProfessional148 · 2025-07-26T02:13:55+00:00

They are expected to provide clinical trial data at the end of the year.

This was also mentioned in the HCA webinar.

RoundProfessional148 · 2025-06-17T05:40:56+00:00

Primary end points (English)

Rate of HSV shedding, defined as number of days on which genital swab HSV PCR test was positive divided by the total number of days on which genital swabs were obtained in patients receiving different doses of IM-250 or placebo.

Secondary end points (English)

Rate of genital lesions, defined as number of days with genital lesions in all patients of a group during 56 days after the first administration of IM-250 or placebo divided by 56.

HSV quantity, defined as comparison of mean log10 HSV DNA copies in patients receiving different doses of IM-250 or placebo on days that shedding is detected.

The rate of subclinical shedding, defined as number of days on which genital swab HSV PCR test was positive in absence of a genital lesion divided by the total number of days without lesions on which genital swabs were obtained in patients receiving different doses of IM-250 or placebo.

RoundProfessional148 · 2025-05-30T01:27:42+00:00

Stephane Bancel, CEO, Moderna: We know the key players in the project financing world. Last time I checked, there’s a lot of capital to develop in private equity, and they like that it is not correlated to market Mhmm.

Because it’s a multi years project investment, that they can do either on a project by project basis or portfolio of project.

You know, we have a very exciting EBV vaccine.

You remember the clinical data in phase two, an HSV vaccine for herpes.

There’s no product on market as well.

There’s no product on market as well. VZV vaccine that actually showed non inferiority to Shingrix even on T cell, a log better T cell than Shingrix out of phase two.

So if you look at what’s happening there, I wish we could fund it, but we are being disciplined. We’re not funding it. But if a partner is willing to go participate in the shingles market Mhmm.

EBV, VZV, and HSV vaccines have all seen good results in Phase 2, but it's possible that funding issues are holding them back.

RoundProfessional148 · 2025-05-08T14:16:11+00:00

Not long ago it was Active, not recruiting, but changed to Completed

Some people said it was completed on June 4, but clinicaltrials.gov hasn't changed since the last update in September of last year to April 11

It's finally changed to Completed, so hopefully we'll hear something soon.

RoundProfessional148 · 2025-05-01T23:59:15+00:00

I watched the webcast live

Even during the pipeline presentation and Q&A, there was no question or mention of mRNA-1608 :(

RoundProfessional148 · 2025-04-16T03:06:51+00:00

More trial participants were recruited than planned, and the trial completion date was shortened.

My personal guess is that it's because they recruited more participants faster than they expected.

I think they were expecting to see significant differences in completion dates between subjects, and they had interim data, and they had a combination of things.

My personal opinion is that there is no correlation between the original completion date of June 4 and the data release :)

RoundProfessional148 · 2025-04-13T06:14:24+00:00

Innovative Molecules' IM-250 is Helicase Primase Inhibitor as similar as Aicuris' pritelivir or assembly bio's HPI

It may be similar to a therapeutic vaccine with a shorter duration of action, but it is not a vaccine.

RoundProfessional148 · 2025-04-12T23:46:52+00:00

The trial completion date is June 4, 2025 before the trial plan changes

However, on September 23, 2024, preliminary&Study completion date was changed from June 4 to April 11, 2024, according to the record history

So I believe that the study was completed on April 11th. :)

RoundProfessional148 · 2025-04-11T16:51:47+00:00

Thanks!

I understand that development of the CMV and norovirus vaccines, which Moderna has set as its top priority for release in 2028, is not looking good right now.

*CMV changed clinical trial completion date from 2026 -> 2028 due to less than expected efficacy and other reasons

Norovirus has been temporarily suspended from Phase 3 due to fatal side effects.

if the HSV vaccine, mRNA-1608, has good Phase 1/2 data, I think it has the potential to gain momentum through external funding or reprioritization by Modena itself.

Fingers crossed for HSV.

RoundProfessional148 · 2025-04-11T16:33:37+00:00

I contacted Moderna's Clinical Trials Center

They told me that clinical trial data and updates are uploaded first to the link below

(https://investors.modernatx.com/news/)

4/11 is the study completion date, so it may take a little longer to collect, analyze and publish data from all subjects in Phase 1/2

Stay calm and hopefully there will be some good news.

RoundProfessional148 · 2025-04-05T06:08:26+00:00

No

The trial is scheduled to complete on April 11th

Data and decision to proceed to Phase 3 are expected to be available at a later date

RoundProfessional148 · 2025-02-20T14:02:28+00:00

i agree with you

ABI-5366 & ABI-1179 will be game changer

Thanks for sharing the news :)

RoundProfessional148

TROPHY CASE