Antibe Therapeutics Inc (CVE:ATE) (OTCQB:ATBPF) has revealed that it plans to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for its lead drug otenaproxesul, formerly known as ATB-346, within the next six months, to allow for Phase 3 clinical trials in the US.
The news accompanied the Toronto-based pharma group's posting of its fiscal first-quarter results to end-June, 2020. Otenaproxesul is targeting the global need for a safer, non-addictive drug for chronic pain and inflammation.
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In successful Phase 2 trial results, released in June this year, both 250 mg and 200 mg doses of ATB-346 showed superiority to placebo in reducing pain with a high level of statistical significance.
"The company anticipates that the Phase 3 program for otenaproxesul will commence in late calendar Q1 or early calendar Q2 2021 and will take approximately 2 years to complete," the firm said in the results statement.
"Although the Phase 3 design is not finalized, it is expected to replicate the Phase 2B GI safety and Phase 2B dose-ranging, efficacy studies in a larger sample size with a longer treatment duration."
Antibe's main regulatory focus is to obtain FDA approval for otenaproxesul given that the USA is the largest pharmaceutical market worldwide. The firm has also engaged a European regulatory consulting agency to develop a strategy for EMA approval.
In keeping with a firm at this stage of development, Antibe's loss from operations for the three month period was C$4,918 against a loss of C$3,176 in the same period last year.
Revenue for the three months came in at C$1,229 compared to C$2,763 for the same period in 2019 due to the impact of the coronavirus (COVID-19) pandemic which caused dental clinics to close for a significant part of the quarter.
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