28 Mar 5 Things to Know About Aligos Therapeutics!
Aligos Therapeutics, Inc. (NASDAQ: ALGS), a clinical-stage biotechnology Company announced the discontinuation of dosing in the first cohort of its candidate ALG-020572, intended for the treatment of chronic hepatitis B. The dosing was stopped after a patient experienced a serious adverse event (SAE) and a brief hospitalization after a significant increase in alanine aminotransferase (ALT), suggestive of drug-induced liver toxicity. The toxicity was reported on multiple dosing of 210 mg ALG-020572, with three more subjects experiencing drug-related ALT flares, which were unexpected as per the Company.
Aligos Therapeutics Inc (NASDAQ: ALGS)
Market Cap: $97.34M; Current Share Price: 2.28 USD
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Chairman and CEO of Aligos, Lawrence M. Blatt, Ph.D., MBA, commented
“We will continue to follow emerging safety and antiviral activity data as these subjects complete their off-treatment follow-up to understand these events further. Although this is undeniably a setback, our team remains committed to developing drug candidates with the potential to improve the lives of patients living with viral and liver diseases.”
ALG-010133 – STOPS™ drug candidate
In January 2022, Aligos halted the development of ALG-010133, intended for the treatment chronic hepatitis B (CHB), based on data from a Phase 1 Study that showed that the escalation dose did not result in HBsAg reduction and did not support further development of the candidate.
The Company also stated that the higher dose levels of 600 mg that were to be evaluated in a subsequent cohort were unlikely to reach the 1 log10 IU/mL HBsAg reduction level that were being targeted by the Company.
The data was reviewed by the management and the Study Review Committee (SRC), leading to a decision to discontinue further development.
Refocus on Existing Pipeline
Aligos’ strategy is to develop drug candidates that can be first assessed as monotherapy and later in combination with other drugs to treat viral and liver diseases with large unmet medical needs.
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The Company will continue to focus on the development of other candidates in the pipeline such as ALG-000184, a capsid assembly modulator for the treatment of chronic suppression of HBV DNA and RNA that is currently undergoing Phase 1 trials; ALG-055009 (THR-Agonist) intended for the treatment of hyperlipidemia, which is also under Phase 1 development. In addition, Aligos is also developing ALG-020572, an ASO for treatment of CHB, that is currently under Phase 1 development.
A Missed Opportunity
Hepatitis B Virus Infection affects an estimated 257 million people worldwide and causes 780,000 deaths per year as per a report by World Health Organisation. In the U.S alone about 2 percent of the population is living with Hepatitis B or Hepatitis C. It can lead to severe complications like Liver Cirrhosis and Hepatocellular Carcinoma if left untreated. At present there are FDA approved vaccinations available to prevent Hepatitis B virus which are 95% effective in prevention and development of chronic diseases related to the infection.
However, there is no treatment available for acute Hepatitis B. The palliative care that is offered after diagnosis of the condition aims at providing comfort, alleviating symptomatic discomfort, slowing down the progression of infection and improving the chances of long-term survival.
This paves way for increased research and development to find the cure for this chronic condition. The industry is witnessing collaborations, development of new products, acquisitions and mergers as a way to capture a majority share of the market. According to a report by Research and Markets, the global hepatitis B virus treatment market size is estimated to reach US$35.63 billion in 2030, growing at a CAGR of 29.41% from 2021-2030.
The growth in the industry is driven by improved diagnostics that help identify the disease on time, rising education and awareness about the condition and its implication, increased access to healthcare, government and regulatory support for companies engaged in finding a cure for the condition and emerging vaccines that call for lower dosages and increased effectiveness.
Strategic Partnerships and Collaborations
In December 2020, the Company entered into an exclusive licensing and research collaboration agreement with Merck (NYSE: MRK), to leverage its oligonucleotide platform technology to discover and develop candidates for the treatment of non-alcoholic steatohepatitis (NASH). The agreement also extends to another additional target in the cardiometabolic/fibrosis space. While the details of the upfront payment are unknown, Aligos is eligible to receive up to $458M in development and commercialization milestones, besides tiered royalty on sales.
In January 2020, Aligos expanded the collaboration agreement with Merck to include the in-license of an early-stage program in a second undisclosed NASH target. Merck can add another target in cardiometabolic/fibrosis space under the terms of the agreement.
The Company has also entered into an agreement with Luxna Biotech for an exclusive license to nucleic acid technology targeting multiple genes in specific diseases from Professor Satosh Obika’s lab at Osaka University. Similarly, the Company has also entered into a collaboration and licensing agreement with KU Leuven and the Rega Institute for Medical Research for a protease inhibitor for COVID-19 and other Zoonotic coronavirus infections. Furthermore, Aligos has a license and supply agreement with AM Chemicals for an exclusive right to use of specific constructs for targeted therapies.
The Company has entered into a licensing agreement with Emory University for a class of non-nucleoside class-II capsid assembly modulators that form the underlying technology of the Company.
Financial Results
As per the Company’s Q4,2021 and FY2021 financial results, the Company had cash, cash equivalents and investments worth $205.8 million on December 31, 2021, as compared to $243.5 million on December 31, 2020. The funds that will be saved on account of discontinuation of the development of ALG-010133 as well as ALG-020572, will be invested on the development of the other pipeline candidates.
Aligos believes that the cash balance, along with cost saving measures and partnering activities will be sufficient to fund its operations until the first half of 2024.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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