Summary
- Moderna completes enrolment in its covid-19 vaccine trial.
- Palatin resumes midstage dry eye study.
- Viveve gets FDA's go ahead for CMRF trial.
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Moderna Advances its Mid stage Covid 19 Trial
Moderna Inc (NASDAQ:MRNA) provided an update about its Phase II clinical trial of Covid 19 vaccine candidate. The company reported that it has completed the patient enrollment for both the cohort of the trial. Moderna has already completed the Phase III trial protocol based on the FDA feedback. For its randomized, placebo-controlled Phase III trial, the company will be recruiting nearly 30,000 patients across the US.
Earlier this month, Moderna had released early stage data for the vaccine candidate. The results demonstrated that mRNA-1273 produced protective antibodies in a small group of healthy volunteers. The company also announced that the vaccine candidate was found to be generally safe. It is looking to initiate late stage trials in July. Moderna has completed manufacturing vaccine doses required for the Phase III trial.
Moderna had completed the enrollment for the first cohort of the trial last month. The group consisted of healthy young adults between the age of 18 years and 55 years. The second cohort comprises older adults aged 55 years and above. The safety results from the older adults cohort were reviewed by the trial’s Data and Safety Monitoring Committee, which recommended the Phase II enrollment to be continued.
The Phase II trial aims to evaluate the safety, reactogenicity and immunogenicity of two mRNA-1273 vaccinations administered 28 days apart. Moderna chief medical officer Tal Zaks said: “We are committed to helping address this ongoing public health emergency and continue to focus on our Phase III study, which remains on track to start in July, less than seven months from the sequencing of the virus.” The Phase II trial is a dose-confirmation, placebo-controlled study.
In Phase II trial, the participants will be administered placebo, a 50?g or a 100?g dose at both vaccinations. The company also elaborated that it has completed enrollment, or the cohorts of older adults aged 56-70 and elderly adults aged 71 and above in the US National Institutes of Health -led Phase I trial. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has formed a clinical trials network for streamlining the process of enrolling participants for COVID 19 vaccine trials.
The Phase III trial will be a randomized, placebo-controlled study with around 30,000 patients enrolled in it. These participants will be given 100µg dose level of the vaccine candidate. The company anticipated to deliver nearly 500 million doses annually at 100?g level. This count may up to one billion doses annually starting next year.
Moderna also recently reported inking a new agreement with Laboratorios Farmacéuticos Rovi SA. The agreement pertains to vial filling and packaging capacity for the company’s potential COVID-19 vaccine for serving the markets outside of the Unites States. The Spain based company will start and new production line and equipment for compounding, filling, automatic visual inspection and labeling.
As per the data provided by the company, Phase II trial is likely to be completed in August, 2021 while the estimated primary completion date is expected to be March, 2021. The primary date is the date the last participant in the clinical study was analyzed or was provided an intervention for collecting final data for the primary outcome measure.
