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Pharmaceutical company Acer Therapeutics has partnered with the National Center for Advancing Translational Sciences (NCATS) to develop emetine hydrochloride for the potential treatment of Covid-19 patients.
Under the research collaboration agreement, the partners will work together to speed-up the clinical development of emetine, which showed broad and potent antiviral activity in preclinical and clinical studies.
Currently, Acer Therapeutics is in discussions with the US Food and Drug Administration (FDA)’s Division of Antivirals (DAV) following initial responses to its pre-investigational new drug (pre-IND) filing.
The company aims to file an IND in the middle of this year, with clinical trial commencement scheduled for the year’s third quarter, contingent on additional capital.
Acer proposed a randomised, blinded, placebo-controlled, multi-centre Phase II/II trial with an adaptive design to assess the safety and antiviral activity of emetine in high-risk, symptomatic, adult Covid-19 patients who do not need hospitalisation.
The objectives of the trial are the safety and efficacy of emetine determined using clinical status at a certain time point along with disease resolution.
Meanwhile, the company is exploring different financing options, including federally-funded research and grants, for the drug’s development.
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.”
Emetine will be administered as a sterile subcutaneous injection. The company will supervise the contract synthesis and manufacturing of the drug for clinical development and potential commercialisation.