TBP:CC - Tetra Bio-Pharma Announces Health Canada Authorization to Proceed with its Oral ARDS-003 New Drug in Human Trial
(TheNewswire)
Montreal, QC - TheNewswire- March 10, 2023 - Tetra Bio-Pharma Inc. (" Tetra " or the" Company ") (TSX:TBP)(OTC:TBPMF) (FRA:JAM1) , a leader incannabinoid-derived drug discovery and development is pleased to announce Health Canada has issued the Company a No ObjectionLetter (NOL) to proceed with its first in human clinical trial usingoral ARDS-003 to treat various immunomodulatory conditions, in Canada.
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TetraBio-Pharma receives approval from Health Canada of its Phase 1Clinical Trial with oral ARDS-003.
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Oral ARDS-003 is a new therapeuticpositioned to modulate acute systemic inflammation and prevent sepsis,acute respiratory distress syndrome (“ARDS”), and organdamage.
The NOL provides the acknowledgement of drug candidacy and authorityto proceed with Tetra’s Phase 1 clinical trial to assess the safety,tolerability, and pharmacokinetics of a single ascending dose of oralARDS-003 in healthy volunteers. The results will guide furtherdevelopment of the drug for patients with hyper inflammatoryconditions such as Acute Respiratory Distress Syndrome (ARDS).
Tetra received $4.5M in support from the Government ofQuebec for the clinical development of ARDS-003 in the indication ofacute respiratory distress syndrome, whether or not it is caused byCOVID-19, as well as in patients with sepsis. The receipt of the NOLwas one of the last conditions to be met to allow the company to drawon this investment.
Dr. Guy Chamberland, CEO and Chief Regulatory Officer at Tetra,commented, “We are excited to see our novel drug candidate, oralARDS-003, moving forward in a clinical setting. As few as 1 out of1,000 compounds make it into Phase 1 human trials. The development ofeffective, out-patient, oral therapies that either directly addressviral infection or treat associated complications such asinflammation, organ damage, or fibrosis, is important in a nationalresponse to future pandemics or health emergencies. With over 12 yearsof preclinical efficacy research in sepsis and cytokinehyperinflammatory reactions, we are very confident that oral ARDS-003will be an effective drug with strong commercial potential.”
A Promising Treatment
Oral ARDS-003 is a novel First in Human (FIH) drug candidatecontaining the active pharmaceutical agent, Onternabez, a potent andselective full agonist of the type 2 cannabinoid receptor (CB2R), anessential immunomodulatory target. Oral ARDS-003 is positioned tomodulate acute systemic inflammation and prevent sepsis, ARDS, andorgan damage. While the clinical profile of ARDS arising from viral(COVID) or bacterial sepsis can vary, hyperinflammation involving adysfunctional immune response is a common mediator of lung damage.Tetra's pre-clinical studies have demonstrated that its drug candidatedecreases this hyperinflammatory response and slows diseaseprogression.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTC-Pink: TBPMF) (FRA: JAM1) is a leaderin cannabinoid-derived drug discovery and development with a FDA and aHealth Canada cleared clinical program aimed at bringing novelprescription drugs and treatments to patients and their healthcareproviders. Their evidence-based scientific approach has enabled themto develop a pipeline of cannabinoid-based drug products for a rangeof medical conditions, including pain, inflammation, and oncology.With patients at the core of what they do, Tetra Bio-Pharma is focusedon providing rigorous scientific validation and safety data requiredfor inclusion into the existing biopharma industry by regulators,physicians and insurance companies.
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Neither the TSX Exchange nor itsRegulation Services Provider (as that term is defined in the policiesof the TSX Exchange) accepts responsibility for the adequacy oraccuracy of this release.
Forward-looking statements
Some statements in this release may contain forward-lookinginformation. All statements, other than of historical fact, thataddress activities, events or developments that the Company believes,expects or anticipates will or may occur in the future (including,without limitation, statements regarding potential acquisitions andfinancings) are forward-looking statements. Forward-looking statementsare generally identifiable by use of the words "may","will", "should", "continue","expect", "anticipate", "estimate","believe", "intend", "plan" or"project" or the negative of these words or other variationson these words or comparable terminology. Forward-looking statementsare subject to a number of risks and uncertainties, many of which arebeyond the Company's ability to control or predict, that may cause theactual results of the Company to differ materially from thosediscussed in the forward-looking statements. Factors that could causeactual results or events to differ materially from currentexpectations include, among other things, without limitation, theinability of the Company to obtain sufficient financing to execute theCompany's business plan; competition; regulation and anticipated andunanticipated costs and delays, the success of the Company's researchand development strategies, including the success of this product orany other product, the applicability of the discoveries made therein,the successful and timely completion and uncertainties related to theregulatory process, the timing of clinical trials, the timing andoutcomes of regulatory or intellectual property decisions and otherrisks disclosed in the Company's public disclosure record on file withthe relevant securities regulatory authorities. Although the Companyhas attempted to identify important factors that could cause actualresults or events to differ materially from those described inforward-looking statements, there may be other factors that causeresults or events not to be as anticipated, estimated or intended.Readers should not place undue reliance on forward-looking statements.The forward-looking statements included in this news release are madeas of the date of this news release and the Company does not undertakean obligation to publicly update such forward-looking statements toreflect new information, subsequent events or otherwise unlessrequired by applicable securities legislation.
For further information, pleasecontact Tetra Bio-Pharma Inc.:
Ms. Natalie Leroux
Phone: + 1 (833) 977-7575
SOURCE Tetra Bio-Pharma Inc.
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