Moderna’s COVID-19 Vaccine And Other News: The Good, Bad And Ugly Of Biopharma – Seeking Alpha

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 trials 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 50g or a 100g 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 100g dose level of the vaccine candidate. The company anticipated to deliver nearly 500 million doses annually at 100g level. This count may up to one billion doses annually starting next year.

Moderna also recently reported inking a new agreement with Laboratorios Farmacuticos Rovi SA. The agreement pertains to vial filling and packaging capacity for the companys 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.

Palatin Technologies Inc. (PTN) announced reinitiating the enrollment of its Phase 2 study with PL9643 for the treatment of dry eye disease. The company had suspended the enrollment for the trial on account of pandemic breakout to ensure safety of the patients. Palatin expects the enrollment to be completed in next 30 to 45 days.

The Phase 2 study is a multi-center, randomized double-masked, placebo-controlled trial. It aims to evaluate the safety and efficacy of PL9643 ophthalmic solution in comparison to placebo for treating the signs and symptoms of dry eye disease. Carl Spana, Ph.D., President and CEO of Palatin said, We are very happy to resume patient recruitment in this Phase 2 study of PL9643 exploring treatment of both the signs of eye damage and the physical symptoms experienced by patients with dry eye disease. The company expects the data readout to be available in the fourth quarter of 2020.

The study aims to enroll up to 150 participants across three sites in the United States. These patients will be randomized in a 1:1 ratio into two arms, PL9643 or placebo. The participants will then have to go through 12-weeks of treatment. The company had initially started the enrolment in February this year.

The two primary endpoints for the trial are inferior corneal fluorescein staining and ocular discomfort. The trial also has several secondary and exploratory outcome measures as well. Palatin is a biopharmaceutical company focusing on developing treatments based on molecules that regulate the melanocortin and natriuretic peptide receptor systems. The company aims to develop targeted, receptor-specific drug candidates for treating diseases with substantial unmet medical need and commercial potential.

Viveve Medical (VIVE) announced that the FDA has given its go ahead to the companys PURSUIT trial for evaluating Cryogen-cooled Monopolar Radiofrequency treatment for managing stress urinary incontinence in women. The trial will enroll 240 participants across 25 sites across the United States and is expected to be launched next quarter.

PURSUIT is a randomized, double-blinded, sham-controlled 12-month trial. The participants will be randomized in a 2:1 ratio for active and sham treatments. The members in the active treatment arm will be administered the CMRF treatment of 90J/cm2 RF and cryogen-cooling. Control arm participants will be given a clinically inert sham treatment consisting of 1J/cm2 RF and <2 degrees tissue cooling cryogen.

The primary efficacy endpoint for the trial is the 1-hour Pad Weight Test at 12 months post-treatment. Scott Durbin, Viveve's chief executive officer. "As we proceed with plans to initiate the PURSUIT Trial, we are equally focused on progressing our short-term, three-arm, SUI feasibility study that is targeted for readout in late summer of this year. The company plans to keep up the momentum for developing its CMRF technology.

The secondary endpoints for the trial include evaluation through the 3-day bladder voiding diary and Quality of Life and SUI benefits. These endpoints will be measured using various tools such as Urogenital Distress Inventory-6, Incontinence Quality of Life, and International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form. The participants will be monitored throughout the study for subject safety.

Viveve Medical, Inc. is a medical technology company and it focuses on developing treatments for various womens intimate health issues. It mainly uses its internationally patented Viveve System incorporates CMRF technology for developing its therapies. The System has been approved by the FDA for use in general surgical procedures.

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Moderna's COVID-19 Vaccine And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha