San Diego, California--(Newsfile Corp. - November 20, 2023) - Thiogenesis Therapeutics Corp. (TSXV: TTI) ("Thiogenesis" or the "Company") announced today that it will undertake a non-brokered private placement of $4.5 million (the "Offering") through the issuance of 6,000,000 common shares of the Company ("Offered Shares") at a price of $0.75 per Common Share.
This Offering is subject to the approval of the TSX Venture Exchange (the "Exchange"). The Company anticipates closing of the Offering as soon as practicable subject to receipt of all necessary regulatory approvals. Upon issuance, the Offered Shares will be subject to a four-month and one day hold period pursuant to securities laws in Canada and, where applicable, Exchange policies.
In connection with the Offering, the Company may pay finder's fees to eligible persons in compliance with applicable securities laws and Exchange policies. The proceeds from the Offering will be used for the completion of regulatory submissions and clearances for its three clinical trial programs, manufacture of its lead compound TTI-0102 for clinical trials and inventory, administration of clinical trials and general working capital purposes.
Corporate Update and Milestones
- On October 5th, 2023, the Company filed its European Investigational Medical Product Dossier ("IMPD") application, the equivalent of an Investigational New Drug ("IND") in the US, for a Phase 2 clinical trial for the treatment of MELAS in France and the Netherlands. The trial will be conducted with the powder formulation of TTI-0102, that was also used in a prior human safety trial. The primary endpoint is improvement in a 12-minute walk test, secondary endpoints are to be determined. The trial is anticipated to begin in Q1-2024, with an interim data analysis in H2-2024.
- Thiogenesis has developed a new tablet formulation of TTI-0102 with its lead supplier, WuXi STA, that will provide for more convenient drug administration and an extended shelf life. A new, faster and cheaper production process has been finalized and a new salt has been added for stability, after pharmacokinetic bioequivalence studies were completed in animals. Additional intellectual property has been filed to extend the Company's patent protection based on this new salt. The tablet formulation will be used in future clinical trials and commercially if it is approved for marketing.
- Subsequent to the anticipated clearance of the IMPD for MELAS, the Company will complete and submit an IMPD for a Phase 2 clinical trial for the treatment of Rett syndrome, to be conducted at a leading academic hospital in France. The Rett syndrome Phase 2 trial is anticipated to start in mid-2024, using the tablet formulation. The primary endpoint will be improvement of behavioral disorders as measured by the ABC behavior scale ("Aberrant Behavior Checklist").
- Thiogenesis is also planning to file an IND for a Phase 2 pediatric NASH clinical trial in Q1-2024, to be conducted at sites in the US. Subject to regulatory clearance by the FDA, the trial is anticipated to begin in mid-2024 using the tablet formulation. The primary endpoint will be the change in percentage of hepatic steatosis (fatty liver disease) following 61 days of treatment. Secondary endpoints will be measuring the change in a number of established liver biomarkers; for example, aspartate aminotransferase ("ALT").
Mitochondrial dysfunction and resulting oxidative stress are thought to be at the core of many metabolic and cellular disorders. Mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes ("MELAS") is the most prevalent of the family of mitochondrial diseases. Many different transfer RNA ("tRNA") mutations can cause MELAS. The most common mutation is in the MTTL1 mitochondrial gene. A single base pair mutation, m.3243A>G, is found in 80% of patients, and a second common mutation, m.3271T>C, is found in 10% of patients. MELAS involves the buildup of lactic acid in the body, known as lactic acidosis. Symptoms include muscle weakness, headaches, seizures, vomiting, loss of appetite and stroke-like episodes. Patients are generally identified in childhood and before the age of 20. The prevalence is over 25,000 patients in Europe, and it is an orphan indication. There are no approved therapies for MELAS in Europe.
TTI-0102 has multiple mechanisms of action that have potential as a therapeutic for MELAS. It is a precursor to the important antioxidant glutathione, which reduces oxidative stress in the mitochondria. It also crosses the blood brain barrier and is a precursor to hypo-taurine which oxidizes into the amino acid taurine. Taurine is well known to reduce seizures.
About Rett Syndrome
Rett syndrome is a neurological disorder that affects young girls and is caused by mutations in the MECP2 gene. Its symptoms include intellectual disability, loss of speech, difficulty breathing, sleep apnea but its most identifiable symptoms are rapid hand movements and seizures. There are over 20,000 girls with Rett syndrome in Europe and there are no approved therapies. It is considered an orphan disease by the European Medicines Agency ("EMA"). TTI-0102 was granted the orphan medicine designation for Rett syndrome by EMA in 2021.
TTI-0102 has two key mechanisms of action that have potential as a therapeutic for Rett syndrome. The first is that it promotes Brain Derived Neurotropic Factor ("BDNF") which is beneficial for neurological disorders because it plays an important role in developing the health of neurons and synapses and in maintaining the health of the brain. Second, recent studies have shown that oxidative stress in the mitochondria is an important contributor to Rett syndrome. TTI-0102, as a precursor to the antioxidant glutathione, which helps combat oxidative stress and restore healthy mitochondrial function.
About Pediatric NASH
Nonalcoholic fatty liver disease ("NAFLD") is a condition in which excess fat builds up in the liver. If left untreated NAFLD often progresses to nonalcoholic steatohepatitis ("NASH") that results in pronounced liver inflammation, irreversible liver damage and fibrosis. Historically, NASH was mostly observed in adult patients but with the world-wide increase in childhood obesity, there has been a significant escalation of NASH in children. In the US alone there is estimated to be over 1.5 million children with NASH. Pediatric NASH can lead to severe and irreversible liver disease in children resulting in cirrhosis ("scarring"), liver failure and liver cancer. There are currently no drugs approved for NASH in the US and there is far lower activity in clinical trials for pediatric NASH.
Pediatric NASH is considered a metabolic disease, many of which have now been studied for signs of oxidative stress in the mitochondria. Recent publications have shown that a functional, healthy mitochondria is an important feature of healthy liver function. TTI-0102's most significant mechanism of action is as a precursor to one of the most important antioxidants, glutathione. Increased rates of glutathione have shown potential in reducing inflammation and fibrosis in pediatric NASH patients in previous human trials.
Thiogenesis Therapeutics, Corp. (TSXV: TTI) is a clinical-stage biopharmaceutical company operating through its wholly owned subsidiary based in San Diego, CA. The Company is publicly traded on the TSX Venture Exchange. Thiogenesis is developing sulfur-containing prodrugs that act as precursors to thiol-active compounds with the potential to treat serious pediatric diseases with unmet medical needs. Thiols have been the subject of promising medical research for many decades and are known for having powerful antioxidant properties and other potential therapeutic activities. The Company's initial target indications include Mitochondrial Encephalopathy Lactic Acidosis and Stroke (MELAS), Rett syndrome and pediatric NASH.
For further information, please contact:
Brook Riggins, Director and CFO
Tel.: (888) 223-9165
Forward Looking Statements
This news release contains certain forward-looking statements and forward-looking information (collectively referred to herein as forward-looking statements) within the meaning of Canadian securities laws including, without limitation, statements with respect to: the Company undertaking a non-brokered private placement to raise up to $4.5 million at a price of $0.75 per Common Share; the Offering being subject to the approval of the TSX Venture Exchange; the Company anticipating closing the Offering as soon as practicable; that the Shares (if sold) will be subject to a four-month and one day hold period; that the Company may pay finder's fees in connection with the Offering; the proceeds (if Shares are sold) from the Offering will be used for development of TTI-002 and working capital; that TTI-002 will be cleared in Europe or the US to conduct clinical trials in MELAS, Rett syndrome and pediatric NASH; and that if cleared by EMA or FDA, Thiogenesis will conduct clinical trials in Europe or the US in MELAS, Rett syndrome or pediatric NASH within the stated timelines. All statements other than statements of historical fact are forward-looking statements. Undue reliance should not be placed on forward-looking statements, which are inherently uncertain, are based on estimates and assumptions, and are subject to known and unknown risks and uncertainties (both general and specific) that contribute to the possibility that the future events or circumstances contemplated by the forward-looking statements will not occur. Although the Company believes that the expectations reflected in the forward-looking statements contained in this press release, and the assumptions on which such forward-looking statements are made, are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements included in this document, as there can be no assurance that the plans, intentions, or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause the Company's actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. The forward-looking statements contained in this news release are made as of the date hereof and the Company does not undertake any obligation to update publicly or to revise any of the included forward-looking statements, except as required by applicable law. The forward-looking statements contained herein are expressly qualified by this cautionary statement.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/187889