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.

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.

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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