CMO Anuj Gaggar said that the company will have interim data for two of the trials by the end of 2024. Image credit: Getty Images / zorazhuang.

US-based biopharma Assembly Bio is planning to launch four clinical trials for its infectious disease pipeline candidates this year.

Assembly Bio CEO Jason Okazaki said the company hopes to initiate two trials in H1 and two in H2, focusing on herpes simplex virus 2 (HSV2), hepatitis B and hepatitis D (HDV).

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Okazaki said that the company’s pipeline targets the huge unmet need in the infectious disease space.

Herpes pipeline

In H1, the company hopes to initiate a first-in-human (FIH) trial of its candidate ABI-5366, a helicase-primase inhibitor targeting patients with HSV2, specifically recurrent genital herpes.

The Phase Ia trial will be in healthy volunteers and will determine the safety and tolerability of the candidate. Okazaki adds that the company hopes the Phase Ia trial will determine early pharmacokinetics (PK) in volunteers which could include asymptomatic patients.

The company is also looking to initiate a trial of another HSV2 candidate ABI-1179, a helicase-primase inhibitor developed by Gilead Sciences and shared with Assembly Bio in a partnership deal.

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The Phase Ia trial, which will be initiated by the end of H2 2024, will also be in healthy volunteers with hopes of getting an early indication of PK.

Okazaki said that ABI-5366 and ABI-1179 target the same protein of the virus but act differently. Once the candidate is in later-stage trials, the company will determine which candidate is stronger to continue development. The company may consider continuing the development of both candidates if they show strengths in different patient populations.

Hepatitis pipeline

The company is also hoping to initiate a Phase Ib trial of ABI-4334, a highly potent next-generation capsid assembly modulator (CAM) for hepatitis B, by the end of H1 2024.

Phase Ib will be a 28-day, first-in-patient trial, with CMO Anuj Gaggar saying that the candidate showed excellent PK at Phase Ia, with hopes of further signs of efficacy in Phase Ib.

The company is also developing an oral candidate ABI-6250, a small molecule orally-bioavailable hepatitis delta virus entry inhibitor, for HDV patients. The company will be launching a Phase Ia trial of the candidate in healthy volunteers by the end of this year.

Gaggar explained that the candidate acts by binding to sodium taurocholate co-transporting polypeptide (NTCP) to block the virus from entering the cell.

Okazaki also said that the company is in pre-clinical trials to discover a pan herpes candidate in partnership with Gilead Sciences, with hopes to initiate a FIH study of the candidate by the end of 2025.

Initial clinical data from both the Phase Ia of ABI-5366 and Phase Ib trial of ABI-4334 is expected by the end of this year, said Gaggar.