Tetra Bio Pharma Inc (OTCMKTS:TBPMF) has completed the modifications in its PPP003 nonclinical safety program to commence the phase 1 clinical trial by the end of this year in healthy volunteers. It expects to initiate phase 2 clinical trial of the drug in patients affected with coronavirus immediately after the phase 1 trial.
Not making any implied claims to eliminate Covid-19
Tetra Bio is not making any implied or expressing any claims to treat coronavirus using the PPP003 program at this moment. According to Chief Scientific Officer of Tetra Bio, Dr. Melanie Kelly, the company has not yet proven effectiveness of the drug – PPP003 in curing or preventing inflammatory cytokine conditions.
Adjusts drug development program of PPP003 for CTA
Tetra Bio has adjusted the drug development program for PPP003 to apply for CTA (Clinical Trial Application) in Canada. It is also tailored for IND (investigational new drug) application in the US as an intravenous sterile finished drug. As per the regulatory requirements, the company has to conduct nonclinical safety trial to support IND/CTA in healthy volunteers for NME (non-molecular entity). It comprises cardiovascular, pharmacokinetics, drug metabolism, repeat dose toxicology, genetic toxicology, and respiratory safety pharmacology. Tetra Bio intends to complete IND/CTA enabling trials to initiate phase 1 clinical trial by Q3 2020.
On initiating the clinical studies in humans, the R&D team of Tetra Bio will advance the nonclinical safety trial and ensures readiness for the phase 2 trial in patients suffering from moderate to severe coronavirus. The company will also, in parallel, completes the nonclinical safety trials to support IND in the US and Canada. In the latter studies, the company will examine early embryonic toxicology, fertility, teratology, and the longer-term repeat-dose toxicology.
100 healthy volunteers in phase 1 study
Tetra Bio will enroll 100 healthy volunteers for the phase 1 clinical trial, which will be conducted at a clinical site situated in Montreal, Quebec. It will evaluate the cardiovascular, pharmacokinetics, and safety aspects of the drug in this trial. In the phase 2 trial, the company will hire 100 patients infected with coronavirus from various hospitals. It will study the molecular mechanisms of cytokine release syndrome in non-treated and treated patients. The company will engage its partner – Onegevity Health in the latter sub-study to choose biomarkers and cytokines for predicting organ damage.