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functional cure—a reduction of the biological indicators of the virus below detectable levels. While currently available drugs called nucleoside analogs can suppress viral replication, Aligos says their functional cure rates are low and these drugs must be given long term. In its IPO filing, the South San Francisco-based biotech says it aims to overcome those limitations with multiple drugs that address different stages in the virus’s life cycle. By helping patients achieve a functional cure, the company hopes to help them avoid the risk of serious and potentially fatal liver problems such as cirrhosis and end-stage liver disease.
The most advanced Aligos drug candidate, ALG-010133, is an oligonucleotide designed to block a molecule called S-antigen transport oligonucleotide polymers (STOP). Aligos says its drug is similar to nucleic acid polymers (NAPs), a type of drug in Phase 2 development by Montreal-based Replicor. That intravenously administered drug is designed to block the release of subviral particles from liver cells. Aligos says its molecule is structurally similar to NAPs but has been “highly optimized” with chemical features intended to make it more potent and allow for subcutaneous dosing. A Phase 1 study of ALG-010133 is underway and is expected to be finished in the second half of 2022.
Other Aligos hepatitis B drugs in preclinical development include a small molecule, an antisense oligonucleotide, and a small-interfering RNA candidate. The company says it believes combinations of the therapies in its portfolio may lead to higher rates of functional cure. On Monday, Aligos announced that the FDA gave the company the green light to start a clinical trial testing its small molecule hepatitis B drug candidate, ALG-000184.
The fatty liver disease nonalcoholic steatohepatitis (NASH) is the second therapeutic area of focus for Aligos. NASH drug candidate ALG-055009 is a small molecule that targets thyroid hormone receptor-beta, one of several receptors for thyroid hormone. Compounds addressing the same target include VK2809, which Viking Therapeutics (NASDAQ: VKTX) is currently testing in a Phase 2b study, and Madrigal Pharmaceuticals (NASDAQ: MDGL) compound resmetirom, which has advanced to Phase 3 testing.
Aligos says tests suggest its drug may be more potent than the Viking drug and more selective than the Madrigal drug. The company says in its filing that its next steps are toxicology tests needed to advance to a clinical trial expected to start in the second half of next year. Aligos is also developing therapies for infections caused by coronaviruses, including SARS-CoV-2. That research is still in the discovery stage.
Aligos was founded in 2018. The company’s largest stockholders are Roche Venture Fund, Versant Ventures, and Baker Brothers, each owning a 12.1 percent stake. Aligos says in its filing that it has raised $186.9 million, most recently a $125 million Series B financing in January. As of June 30, Aligos reported a cash position of $88.1 million. Aligos set a preliminary $100 million target for its IPO. The company has applied for a Nasdaq listing under the stock symbol “ALGS.” The company says it will use the IPO proceeds for the manufacturing and clinical development of its hepatitis B and NASH drug candidates.
—Tarsus Pharmaceuticals set an $86M goal as it eyes the completion of clinical testing and an expected regulatory submission for its lead drug, a treatment for Demodex blepharitis. Blepharitis is the inflammation and irritation of the eylid. Demodex blepharitis is caused by infestation by Demodex mites. Irvine, CA-based Tarsus says that according to published research, an estimated 20 million people in the US suffer from blepharitis. About 45 percent of those cases are caused by Demodex infestation.
Lead Tarsus drug candidate TP-03 is an eye drop containing lotilaner, which is part of a class of anti-parasitic molecules called isoxazolines, according to the filing. The drug is designed to block pathways in a mite’s central nervous system, leading to paralysis and eventual death. The company says its drug has low affinity to the same pathways in mammals, and therefore has no effect on the human nervous system.
Tarsus formed in 2016. According to the IPO filing, the company has financed its operations with $61 million in private placements. Its largest stockholder is Vivo Capital Fund, with a 21.4 percent stake, followed by Horowitz Group, a family office that owns about 12.9 percent. Tarsus is preparing for two Phase 3 studies, each enrolling about 350 patients. The first study, intended to further evaluate the safety and efficacy of TP-03, started earlier this month. Preliminary data are expected in 2021.
The second Phase 3 clinical trial, a confirmatory study, is expected to begin next year. The company expects the results from both late-stage studies will be enough to support a regulatory submission to the FDA. Tarsus says it also plans to seek regulatory approval in other markets, including Europe and Japan. If Tarsus completes its IPO, the company expects to trade on the Nasdaq under the stock symbol “TARS.”
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