Regulatory activities have not slowed down despite the COVID-19 crisis. These activities are now performed by Tetra’s employees from their home offices. Tetra confirms that it will continue all planned Clinical Trial Applications (CTA), DIN (Drug Identification Number applications), veterinary drug clinical trial applications (Experimental Studies Certificate; ESC) and Pre-Submission meetings in Canada and Investigational New Drug Applications (IND), veterinary IND applications, Pre-IND meetings (PIND) (including Type B and C meetings), Orphan Drug Designation (ODD) applications in the United States. European regulatory activities will also continue.
Tetra’s clinical research team is working to increase the number of clinical sites in Canada and the USA so that it can accelerate the enrolment of patients when the crisis is over. To date the ophthalmic clinical trial has been moving along as per expected timelines. Half of the patient dogs have completed the treatment phase of the study. There was no treatment related adverse events. Tetra expects to complete this trial in this fiscal quarter (end of April) or early in fiscal Q3 and will then report the key outcomes of the study. The corporation has already begun planning the second trial for the treatment of canine indolent corneal ulcers. This second trial will involve regulatory filings in both Canada and the USA. The IND-enabling toxicology studies with HU308 for the human ocular trials are continuing as planned.
During this crisis period, Tetra will be submitting both an IND and CTA to initiate a clinical trial in Canada and the USA for its Orphan Drug HCC011. The corporation will continue forward with its PIND meeting request to discuss with the FDA the marketing requirements for this Orphan Drug that would benefit from FDA’s expedited programs as well as the 505(b)(2) NDA (New Drug Application) regulatory pathway.
Serenity and Reborn activities will be slowed by the crisis. However, the extent of any delays in the clinical activities will be a result of the ultimate effect that this crisis has on factors such as availability of physicians, clinics and enrolment. This is fully understandable as hospital-based physicians have been mobilized to treat individuals infected by the COVID-19 virus, which we all consider to be urgent. That is why Company immediately began procedures to increase the number of clinical sites. Tetra has prioritized obtaining critical clinical research data during this period that had previously been planned for late 2020. The clinical outcomes from these studies will provide important scientific and medical information on CAUMZTD and HCC011. This information is required for the marketing application for any new drug.
Tetra has communicated with all of its drug suppliers, including those that produce THC, CBD, HU308 and PPP001. Current assessment by these firms is that the COVID-19 crisis will not significantly affect supply of the clinical research medications. Tetra’s main QIXLEEF clinical site should be minimally affected by the crisis as it is a private clinic and not a hospital.
Panag Pharma and TALLC research and development activities will be moving along as planned. CB2 Therapeutics pre-commercialization activities will also continue as planned.
“We are extremely relieved that majority of our employees will be able to work from their home offices. Tetra’s virtual environment is well established and is now proving to be a great advantage in ensuring the health and safety of our team and the continuity of our priority projects during this unprecedented time. Special working conditions currently allow Tetra’s manufacturing staff to work in a safe environment. If required to ensure the safety of employees, the corporation also implemented plans that could allow these employees to work from their home and continue to advance Tetra priority projects. We are fortunate that the recent financing allows us to move forward during these difficult times. Tetra’s business model allowed the company to rapidly implement safe working policies without affecting our productivity.” said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TBP.V) (TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies. Could we work in “existing regulatory standards of safety and clinical evidence for pharmaceutical products”.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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