Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1) announced multiple clinical advancements, including the dosing of the first patient in its REBORN1 trial of QIXLEEF as a treatment for cancer pain and positive results from a study of coronavirus-infected mice treated with ARDS-003.
The REBORN1 trial is designed to evaluate the company's inhaled proprietary drug formulation, QIXLEEF, compared to immediate-release oral morphine sulfate in terms of pain relief in people living with cancer. QIXLEEF is a botanical drug product with a fixed ratio of THC and CBD and it is inhaled through a Class 2 medical device vaporizer.
Patient enrolment is a multistep process that can last up to two weeks to determine the eligibility of the patient, the company said, which leads to the random allocation of the patient to either the immediate release morphine or the QIXLEEF arm of the trial.
READ: Tetra Bio-Pharma secures another C$1.5M after underwriters exercise overallotment option on C$10M financing
In the REBORN1 study, the screening process requires eligible patients complete a questionnaire for seven continuous days to assess the intensity of their background chronic pain, the number of episodes of breakthrough cancer pain and opioid use. Chronic pain is common in patients suffering from breakthrough pain and should be adequately controlled with long-acting opioids to prevent any confusion in the analysis of the efficacy of QIXLEEF on breakthrough pain, the company said.
"We are very pleased to announce that the screening process has been initiated and eligible patients identified,” CEO and Chief Regulatory Officer (CRO) Dr Guy Chamberland said in a statement. “The first REBORN1 patient is being monitored to ensure a stable background chronic pain treatment. As soon as this 7-day period is over, this patient with breakthrough pain will be the first patient to receive QIXLEEF. Over the next months, the trial will provide data on the outcome of the cannabis treatment versus immediate-release morphine."
Sars-CoV-2 infected mice
Pre-clinical studies are ongoing to examine ARDS-003 in mice infected with Sars-CoV-2, the virus that causes COVID-19. SARS-CoV-2 enters the human body by binding to human angiotensin-converting enzyme 2 (ACE2), and the study is treating mice carrying a human ACE2 coding sequence, which generates a robust model of COVID-19 that recapitulates clinical features of the human disease, the company said.
Using Daily Health Scores (DHS), in which lower numbers mean more clinical progress, researchers found that infected mice dosed with ARDS-003 (10 mg/kg) had lower scores after a week than untreated mice and in some cases comparable scores to healthy mice. Additional studies are planned to further determine the dose range and treatment regimen that provides optimal clinical benefit, as well as to describe the underlying mechanisms contributing to this benefit.
"The severity of Sars-CoV-2 infection in a patient has significant impacts on our health care system,” Dr Chamberland said. “ARDS-003 can become a valuable therapeutic if clinical trials demonstrate a reduction in the severity of the infection. Tetra is also studying the benefits of ARDS-003 on the immune system response to establish advantages over the use of dexamethasone in Acute Respiratory Distress Syndrome or Sepsis patients. We believe a broad action immunomodulator that does not result in pronounced immune suppression will play a more significant role."
ARDS-003 IND application process
Tetra has also completed a consultation process with both the US Food and Drug Administration (FDA) and Health Canada (HC) for ARDS-003. Based on feedback from HC, the Phase 1a and 1b protocols were modified to a single protocol with an adaptive study design. Phase 1a will be performed in healthy volunteers and Phase 1b in hospitalized COVID-19 patients with severe pneumonia, the company said.
The study will be initiated at six sites across the US, Canada and Brazil. Batches of ARDS-003 have been manufactured over the last several months, allowing Tetra to create the chemistry, manufacturing and controls information required to submit the US Investigational New Drug (IND) application.
"Many investors have been waiting for the submission of the IND to the FDA,” Dr Chamberland said. “As with any new molecular entity drug, Tetra had to develop the data required by the FDA and we can now say that the IND is being filed," he added.
At-the-Market Equity Program
Tetra has established an at–the–market equity program that allows it to issue up to C$10 million worth of common shares at its discretion through the Toronto Stock Exchange.
"Having recently completed two bought-deal offerings (including the exercise of the over-allotment option in each of these offerings) for aggregate gross proceeds of $25.9 million, we have also witnessed an increased rate of exercise of outstanding warrants to purchase our common shares,” CFO Jean-François Boily said.
“The net proceeds from these offerings and warrants exercises will primarily go towards the advancement of our ARDS-003, REBORN1 and PLENITUDE clinical trials. We believe the ATM Program will provide us with an opportunity to firmly solidify our balance sheet. We expect that the ATM Program will serve both Tetra and our shareholders very well, as it will constitute an additional tool to raise funds on an ‘as-needed’ basis, without the expenses and fees associated with larger-scale financings."
Tetra Bio-Pharma is a leader in cannabinoid-derived drug discovery and development with a FDA and a HC cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
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