The Phase II PRO-CL-002 trial is assessing the PTX-COVID19-B vaccine in healthy adults. Credit: DoroT Schenk from Pixabay.

Everest Medicines and its partner Providence Therapeutics have reported positive findings from the Phase II PRO-CL-002 clinical trial of a messenger ribonucleic acid (mRNA) Covid-19 vaccine candidate, PTX-COVID19-B. 

The double-dummy, randomised, observer-blind trial underway is assessing the safety, tolerability, and immunogenicity of a 40μg dose of PTX-COVID19-B against Pfizer and BioNTech’s Comirnaty in healthy adult subjects.

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It recruited 565 subjects aged 18 to 64 years at various sites in Canada and South Africa. 

These participants were categorised into a 2:1 ratio to receive two doses of either PTX-COVID19-B at a gap of four weeks, or Comirnaty at a gap of three weeks.

Assessing the tolerability and safety of PTX-COVID19-B at four weeks following the second dose is the trial’s primary objective.

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As per the geometric mean titer (GMT) ratio of neutralising antibodies seen two weeks following the second shot, PTX-COVID19-B was found to be non-inferior to Comirnaty. 

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PTX-COVID19-B was also found to be well-tolerated, with a safety and tolerability profile in line with Comirnaty. 

It also showed non-inferiority in terms of seroresponse rates. 

Everest Medicines CEO Rogers Yongqing Luo said: “To our knowledge, this is the first clinical trial directly comparing a candidate vaccine to an approved mRNA vaccine. 

“We aim to initiate Phase III trials quickly and launch our Covid-19 vaccines in our territories. 

“Since completion of the transaction with Providence, we have made significant progress including in completing clinical-scale technology transfer and building commercial-scale local manufacturing capabilities in Jiashan, Zhejiang Province. 

The company intends to submit Investigational New Drug (IND) applications for Phase III trials of PTX-COVID19-B as a booster. 

Everest and Providence signed a strategic collaboration in September last year to advance mRNA vaccines and drugs. 

Under this deal, Everest holds the rights to PTX-COVID19-B for Pakistan, Greater China, and Southeast Asia.

In December last year, the companies reported that PTX-COVID19-B received approval to be part of the World Health Organization Solidarity Trial Vaccines programme.

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