As a Long Term investor of IPIX, I am not as interested in analyzing a specific PR as I am trying to determine the overall value of IPIX’s intellectual properties to determine if it is worth holding on to for hopefully future SP increases. The Phase2 B-CV19 Top Line results announced in November of not meeting End-Point goals were a definite setback to IPIX and its investors and frankly a gut-punch to those of us who have been around for many years. Here are some of my thoughts (both positive and negative) on the 3/7/22 PR that consider the bigger picture.
On a positive note the Secondary Results of the trial were actually quite positive and the safety profile positive as well. Some of the data points include:
- The incidence of serious adverse events was the same (12 percent on active, 12 percent on placebo), and no serious adverse events were reported as related to study treatment.
- 97 percent of the Brilacidin 5-dose group had achieved this NEWS2 endpoint compared to 84 percent of patients in the pooled placebo group. This represents a 15.5% improvement in NEWS2 of Brilacidin over SOC. NEWS2 is based on certain physiological parameters—respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse, level of consciousness, and temperature. NEWS2 has been used as an endpoint for several COVID-19 clinical trials.
- For those patients with baseline values for C-Reactive Protein (CRP) in the highest quartile (4th quartile), all patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29, compared to 77 percent of patients in the pooled placebo subgroup.
- Additionally, for those patients with baseline values for Interleukin-6 (IL-6) in the highest quartile, more patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29 (89 percent compared to 67 percent on placebo).
- For those patients with baseline values for viral load in the highest quartile, more patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29 (92 percent compared to 82 percent on placebo). Time to sustained recovery was also on average shorter in the Brilacidin 5-dose subgroup compared to placebo for this quartile of patients. This is notable given median time from symptom onset to treatment randomization averaged 9.53 days in the Brilacidin COVID-19 trial, and thus likely occurred after peak viral load in most patients.
- If a patient started study treatment within fewer than 7 days of onset of COVID-19 symptoms, patients in the Brilacidin 5-dose group achieved sustained recovery more quickly compared to the pooled placebo group (p=0.03). For this patient population, early treatment with Brilacidin from onset of symptoms appeared to have a potential positive impact on time to sustained recovery (the study’s primary endpoint), suggesting cases that can be treated close to initial onset of disease may be an attractive population to target for Brilacidin treatment.
Compassionate Use bio-markers showed improvements but CU patients were all too severely compromised to save. IMO the compassionate thing to do would be to treat these patients with Brilacidin much earlier in the disease progression to give them a better chance of survival.
The PR discusses Standard of Care (SOC) and interestingly 87% of the 120 patients (105 patients) got aggressive treatments that likely masked any benefit that Brilacidin could provide at the dosage allowed for the study. This patient population is the same ratio of Russian to U.S. patients in the study which I do not think is a coincidence. IMO these 2 paragraphs summarize why Brilacidin did not meet the trial’s primary end points.
“Review of Brilacidin Phase 2 COVID-19 trial data showed most patients (>87 percent) received treatment with systemic corticosteroids (generally at high doses, and for long durations), and treatment with mucolytics (>82 percent), antivirals (>68 percent), analgesics (>56 percent), immunosuppressants (>45 percent), anti-thrombotic agents (>97 percent), and other supportive medications as SoC for COVID-19.
These seemingly aggressive SoC treatment strategies are likely attributable to the Delta variant of SARS-CoV-2, which became prevalent during trial enrollment and has been associated with significantly higher in-hospital mortality compared to earlier SARS-CoV-2 variants. Such implementation of a more aggressive COVID-19 SOC, as has been reported by other companies evaluating COVID-19 trial results, may have contributed to an overall lessening of observable Brilacidin treatment effects.”
Leo made it clear that Brilacidin has value as an antiviral to treat CV19 and as a Broad Spectrum antiviral but to advance Brilacidin for these instances will require government funding.
” 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.”
Leo will focus IPIX cash to fund B-OM and B-IBD UC. Leo also made it clear that he continues to explore partnerships:
“The Company is evaluating a number of potential pipeline additions and other unique business opportunities, including investments in medical-related technologies. In certain instances, management is in advanced discussions for products believed to be accretive to revenue by diversifying Innovation’s portfolio. The Company will provide updates on all such matters as appropriate.”
IMO IPIX SP will continue to be controlled and artificially compressed by criminal Hedge Funds using illegal NSS until Leo is able to secure a non-dilutive funding deal via government grant funding, partnership or some type of merger. IMO investors that grew impatient have sold off. Investors that have chosen to hold on to their IPIX shares will have to outlast the criminal control until the above mentioned funding takes place.
On a positive note the Secondary Results of the trial were actually quite positive and the safety profile positive as well. Some of the data points include:
- The incidence of serious adverse events was the same (12 percent on active, 12 percent on placebo), and no serious adverse events were reported as related to study treatment.
- 97 percent of the Brilacidin 5-dose group had achieved this NEWS2 endpoint compared to 84 percent of patients in the pooled placebo group. This represents a 15.5% improvement in NEWS2 of Brilacidin over SOC. NEWS2 is based on certain physiological parameters—respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse, level of consciousness, and temperature. NEWS2 has been used as an endpoint for several COVID-19 clinical trials.
- For those patients with baseline values for C-Reactive Protein (CRP) in the highest quartile (4th quartile), all patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29, compared to 77 percent of patients in the pooled placebo subgroup.
- Additionally, for those patients with baseline values for Interleukin-6 (IL-6) in the highest quartile, more patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29 (89 percent compared to 67 percent on placebo).
- For those patients with baseline values for viral load in the highest quartile, more patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29 (92 percent compared to 82 percent on placebo). Time to sustained recovery was also on average shorter in the Brilacidin 5-dose subgroup compared to placebo for this quartile of patients. This is notable given median time from symptom onset to treatment randomization averaged 9.53 days in the Brilacidin COVID-19 trial, and thus likely occurred after peak viral load in most patients.
- If a patient started study treatment within fewer than 7 days of onset of COVID-19 symptoms, patients in the Brilacidin 5-dose group achieved sustained recovery more quickly compared to the pooled placebo group (p=0.03). For this patient population, early treatment with Brilacidin from onset of symptoms appeared to have a potential positive impact on time to sustained recovery (the study’s primary endpoint), suggesting cases that can be treated close to initial onset of disease may be an attractive population to target for Brilacidin treatment.
Compassionate Use bio-markers showed improvements but CU patients were all too severely compromised to save. IMO the compassionate thing to do would be to treat these patients with Brilacidin much earlier in the disease progression to give them a better chance of survival.
The PR discusses Standard of Care (SOC) and interestingly 87% of the 120 patients (105 patients) got aggressive treatments that likely masked any benefit that Brilacidin could provide at the dosage allowed for the study. This patient population is the same ratio of Russian to U.S. patients in the study which I do not think is a coincidence. IMO these 2 paragraphs summarize why Brilacidin did not meet the trial’s primary end points.
“Review of Brilacidin Phase 2 COVID-19 trial data showed most patients (>87 percent) received treatment with systemic corticosteroids (generally at high doses, and for long durations), and treatment with mucolytics (>82 percent), antivirals (>68 percent), analgesics (>56 percent), immunosuppressants (>45 percent), anti-thrombotic agents (>97 percent), and other supportive medications as SoC for COVID-19.
These seemingly aggressive SoC treatment strategies are likely attributable to the Delta variant of SARS-CoV-2, which became prevalent during trial enrollment and has been associated with significantly higher in-hospital mortality compared to earlier SARS-CoV-2 variants. Such implementation of a more aggressive COVID-19 SOC, as has been reported by other companies evaluating COVID-19 trial results, may have contributed to an overall lessening of observable Brilacidin treatment effects.”
Leo made it clear that Brilacidin has value as an antiviral to treat CV19 and as a Broad Spectrum antiviral but to advance Brilacidin for these instances will require government funding.
” 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.”
Leo will focus IPIX cash to fund B-OM and B-IBD UC. Leo also made it clear that he continues to explore partnerships:
“The Company is evaluating a number of potential pipeline additions and other unique business opportunities, including investments in medical-related technologies. In certain instances, management is in advanced discussions for products believed to be accretive to revenue by diversifying Innovation’s portfolio. The Company will provide updates on all such matters as appropriate.”
IMO IPIX SP will continue to be controlled and artificially compressed by criminal Hedge Funds using illegal NSS until Leo is able to secure a non-dilutive funding deal via government grant funding, partnership or some type of merger. IMO investors that grew impatient have sold off. Investors that have chosen to hold on to their IPIX shares will have to outlast the criminal control until the above mentioned funding takes place.
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