Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

Most of what concerns you and Mr Locke about the Brilacidin Phase 2 trials ignores the fact that this is an adaptive trial and has the ability to add additional patients and even extend the trial to a Phase 3 seamlessly if Brilacidin is found to be safe and effective.

Below the FDA describes different scenarios describing current clinical trials for Covid 19. Brilacidin's protocol will likely have elements of these trials

From the FDA update:

https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials

"The Adaptive COVID-19 Treatment Trial (ACTT) is evaluating the safety and efficacy of the investigational antiviral Veklury® (remdesivir), developed by Gilead Sciences Inc., alone and in combination with other therapeutics. The patient population is hospitalized adults with COVID-19 and evidence of lung involvement, including rattling sounds when breathing (rales) with a need for supplemental oxygen or abnormal chest X-rays, or illness requiring mechanical ventilation."


"The ACTIV-2 master protocol(link is external) is designed as a Phase 2 trial that can expand seamlessly to Phase 3. The trial will enroll adults with COVID-19 who are not hospitalized and aims to evaluate safety, to understand if the investigational treatment can reduce the duration of symptoms, and to test if the treatment can increase the proportion of participants with undetectable virus. It will perform testing using nasopharyngeal swabs at specific time points. Multiple therapies, beginning with a monoclonal antibody but including other types of therapeutics, will be tested in ACTIV-2."

"Working in an unprecedented timeframe, the ACTIV public-private partnership has evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized the most promising candidates, designed and harmonized five adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates.

"Master protocols allow coordinated and efficient evaluation of multiple investigational agents as they become available, but within the same clinical trial structure, across multiple study sites. Adaptive protocols swiftly weed out experimental drugs that do not demonstrate effectiveness and identify those that do. Adaptive master protocols reduce administrative burden and cost, provide a flexible framework to rapidly identify drugs that work, and rapidly move additional experimental agents into the trial."

GLTA Farrell