Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

I believe the government, FDA,and NIH are now and have been desperate for an antiviral effective against Covid . The biggest need is for hospitalized patients with severe pulmonary failure. The death rate with mechanically ventilated Covid patients is between 80% to 90%.

At the time IPIX had their meeting with the FDA the Covid infection, hospitalization and death rate were escalating.

It would be in any drug company's financial interest to begin their Covid drug studies on patients with the highest chance for
success, patients with mild disease, but in this setting that was not possible for Brilacidin or any covid therapeutic.

I have no direct information on IPIX's meeting with FDA, but I do understand the tremendous political and humanitarian pressure to help the covid patients who were the sickest with the highest death rate. I also know virtually every antiviral drug's initial clinical trial was on the moderate to severely ill hospitalized covid patients.It is clear to me the only possible option the FDA gave IPIX was to study Brilacidin on the moderate to severe hospitalized covid patient

Even though the Covid infection rate is now falling, the death rate has remained surprisingly high. The NIH,FDA and the government are still desperate to find better treatments for Covid. The government seems interested in studying therapeutics in its fully funded ACTIV trials. Now the Biden administration is funding a 3 billion dollar program for Covid and antiviral treatments.

https://www.niaid.nih.gov/news-events/biden-administration-invest-3-billion-american-rescue-plan-part-covid-19-antiviral

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

I believe the latest PR will lead to Brilacidin being funded for another covid trial as outlined by Mr Ehrlich:

"Given the need for development of new small molecule antivirals and immunomodulators, the Company is planning to submit Brilacidin for possible inclusion in government-sponsored COVID-19 trial platforms, e.g., the NIH ACTIV program. Platform trials, which typically enroll hundreds of patients per treatment arm, can more accurately evaluate the treatment potential of COVID-19 drug candidates. Pursing a biomarker-driven approach, increasing Brilacidin dosing and treatment duration, targeting different patient populations, testing Brilacidin in combination with drugs exhibiting different mechanisms of action (e.g., remdesivir, given strong synergistic in vitro data)—all are possible elements of any future Brilacidin COVID-19 trial design. Compassionate use of Brilacidin also is anticipated to continue, which could further inform Brilacidin’s treatment effects in COVID-19. For more details on the Company’s Compassionate Use policy, please visit:
https://www.ipharminc.com/expanded-access-and-compassionate-use

The Company also plans to seek additional clinical development support from the NIH Antiviral Program for Pandemics (APP). Brilacidin for prophylactic use, including assessing Brilacidin in pre-clinical animal models, is of particular interest due to Brilacidin’s blocking and neutralizing antiviral properties and industry investment in developing intranasal-targeted, direct-acting antivirals. Preliminary Brilacidin formulation work for inhaled delivery has been conducted, with the NIH APP a potential avenue to expand on this work, along with exploring the subcutaneous administration of Brilacidin, which has greater than 70 percent bioavailability via this route of administration."

GLTA,Farrell... all in my opinion