Ausperbio announces AHB-137 Monotherapy achieves 30% functional cure in HBe-negative CHB patients on stable NA therapy

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@availlant @john.tavis @ThomasTu appreciated if you can share your thoughts on this study results and its data behind it!

Thanks!

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In patients with baseline HBsAg 100–1,000 IU/mL, 30% of participants achieved functional cure (HBsAg <0.05 IU/mL and HBV DNA<LLOQ) in both 225 mg and 300 mg cohorts. In patients with baseline HBsAg 100–3,000 IU/mL, functional cure was achieved in 13% (225 mg) and 19% (300 mg). Based on these results, the 300 mg dose has been selected for further Phase II studies.

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Dear @Nawab,

These results are in unicorn patients (HBsAg < 1000 IU/mL at baseline) and are rather unremarkable since pegIFN monotherapy achieves the same response in these patients. Unicorn patients represent about 5% of patients globally.

Of course the devil is in the details and we can see that after removal of NUC therapy HBsAg negativity is not being maintained in all patients. This is similar to what has been observed with the cousin to AHB-137 (bepirovirsen).

@availlant

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Dear @availlant,

We know that there are many drugs in the pipeline. But which drug, under development, is the most promising candidate for hepatitis b that can clear HBV iDNA and cccDNA. Which drug has that potential as per your knowledge?

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Dear @Nawab,

This is no drug under development which can eliminate cccDNA. However, we do know that functional can be established with the removal of or substantial reduction in HBV iDNA. The absence of HBsAg allows for effective long term silencing of cccDNA.

Here are the results for HBV functional cure so far:

NUCs: <1% per year of therapy

pegIFN: 6% (mostly unicorn patients)

siRNA (immunotherapy): 0%

antisense: 0%

bepirovirsen / AHB-137 (immunotherapy): 10% with follow up > 24 weeks (mostly unicorn patients)

NAPs (REP 2139-Mg): 56% (regardless of baseline HBsAg)

@availlant

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There haven’t been any significant updates regarding NAPs development for Hep B in more than 2 years. Are the trials still in Phase II? Do you believe REP 2139-Mg will be available in the next 5 years?

Thanks!

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Dear @Ace ,

The results from our latest compassionate use study were just published in the Journal of Hepatology.

https://www.journal-of-hepatology.eu/article/S0168-8278(25)02612-1/abstract

We are working to making the REP 2139-Mg available to all patients as soon as possible.

Please keep consulting our website www.replicor.com for developmental updates.

@availlant

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Dear @availlant,

Great work. But no Replicor presence at international hepatitis meetings this year?

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Dear @Nawab ,

We will be back in the cycle when new clinical data is available. This is common practice for most companies in the space.

@availlant

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Hi @availlant happy new yr!!
I was just reading the Journal regarding NAPs cure rate… it says 18% for HBV. I thought the previous numbers were higher than that. Am I misreading something?

I can’t wait this medicine!!

Thanks