Acer Therapeutics has joined forces with the US National Center for Advancing Translational Sciences (NCATS) to develop emetine hydrochloride as a potential treatment for Covid-19 patients.
In this regard, the Texas-based Acer Therapeutics has signed a research collaboration agreement with NCATS, which is one of the National Institutes of Health (NIH) in the US.
As per the agreement terms, the partners will work together in speeding up the clinical development of emetine, which is a broad-acting and potent antiviral as seen across various preclinical and clinical studies.
Acer Therapeutics revealed that it is having talks with the Division of Antivirals (DAV) at the US Food and Drug Administration (FDA) after getting its initial written responses to its pre-investigational new drug (pre-IND) package.
The pharma company said that it is working towards making an IND submission in mid-2020, while targeting initiation of a clinical trial in the third quarter of this year, subject to additional capital.
Acer Therapeutics is looking to conduct an adaptive design phase 2/3 randomised, blinded, placebo-controlled multi-center trial to assess the safety and antiviral activity of emetine in high-risk, symptomatic adult patients with confirmed novel coronavirus infection, who do not need hospitalisation.
The objective of the trial will be to determine the safety and efficacy of emetine through clinical status at a specific timepoint apart from disease resolution, said the pharma company.
Emetine will be administered to the participating Covid-19 patients as a sterile subcutaneous injection. The pharma company will oversee the contract synthesis and manufacturing of the antiviral for clinical development and potential commercialisation.
Acer Therapeutics CEO and founder Chris Schelling said: “We are very pleased to be selected by NCATS and look forward to collaborating on the development of emetine, a broad-acting and potent antiviral identified by NCATS as their best preclinical opportunity for further clinical development for the treatment of COVID-19.
“With a collaboration agreement in place, ongoing discussions with the FDA toward IND submission, and several potentially non-dilutive funding sources being pursued, we believe we are well-positioned to advance the clinical development of emetine.”