There is no approved standard treatment approved for for NASH yet. Credit: Marko Aliaksandr/Shutterstock.com.

Aligos Therapeutics has initiated a securities purchase agreement for private placement funding worth approximately $92m.

The private placement will see Aligos selling 31,429,266 shares of common stock at $0.8193 per share, in addition to pre funded warrants. The private placement will close on October 25. With the addition of private placement proceeds, the financial runway, as per the company, will now be sufficient to fund projects through Q4 2025.

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Combined with existing capital, the funds will be used to expand the company’s drug portfolio and support its Phase II ALG-000184 study for chronic hepatitis B  and Phase IIa ALG-055009 study for nonalcoholic steatohepatitis (NASH).

The Phase II CHB study evaluates ALG-000184 as a treatment for E antigen-positive chronic hepatitis B. . The drug is a E antigen capsid assembly modulator (CAM-E) candidate designed to inhibit RNA encapsidation, thereby reducing the circulation of viral DNA and RNA in CHB patients.

As per Aligos CEO Lawrence Blatt, data from the ongoing trial demonstrates “impressive” lowering activity of DNA, RNA, and HBsAg in dosed patients.

Having received an IND for ALG-055009 in September, the company plans to submit a protocol for a Phase IIa NASH trial to the United States Food and Drug Administration (FDA) by the end of this year. The company expects Phase IIa enrollment to begin early in 2024 and hopes to release topline data by the end of 2024.  

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At the 2023 Paris Hepatology Conference, Aligos revealed that ALG-055009 demonstrated high THR-β selectivity in preclinical animal models as well as “favourable” pharmacokinetics data in the Phase I (NCT05090111) ALG-055009 study. The upcoming Phase IIa will be a randomised, double-blind, placebo-controlled trial evaluating the efficacy of ALG-055009 for NASH. Patients will be divided into active arms and treated with varying dose levels of the drug over a period of 12 weeks. As a primary endpoint, the study will assess changes in liver fat content between baseline and week 12 as determined by magnetic resonance imaging derived proton density fact fraction (MRI-PDFF).

Aligos is also exploring oligonucleotides as a potential treatment for NASH. In May 2023, Aligos announced a $109m research collaboration with China-based Xiamen Amoytop Biotech.

The race to be the first-ever approved treatment for NASH is well underway, with drug developers zeroing in on the THR-β agonists drug class for treating NASH. In the past year, companies like Madrigal Pharmaceuticals, Viking Therapeutics, and Terns Pharmaceuticals released encouraging study data with their respective THR-β agonist candidates.

In addition to THR-β agonists, interest in GLP-1 agonists and FGF21 agonists as potential NASH treatments has increased. Amidst arising competition, GlobalData forecasts drugmakers to undertake major licensing deals and acquisitions in coming years.