IPIX Stock is gearing up for a major move after receiving a Pre-IND response from the FDA on its planned clinical trial. This is a critical first step in getting Brilacidin, a defensin-mimetic drug candidate, into the marketplace for the treatment of COVID-19. The FDA response completes the Pre-Investigational New Drug (Pre-IND) process.
In looking at the chart above, you can see that IPIX stock has rock-solid support at $.20 a share. IPIX stock has now built a base from which it will start climbing again. The $.20 level was critical resistance before the move in June and now has acted as support, a hallmark of classic technical analysis.
IPIX stock is a clinical-stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious disease, and dermatologic diseases.
Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources.
Positive results were also observed in Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019.
A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection.
Brilacidin, based on promising in vitro antiviral activity against SARS-CoV-2, is being evaluated as a potential treatment for COVID-19.
Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations, and has successfully completed a Phase 2 trial in Ovarian Cancer.
Pre-IND Response From The FDA
The FDA provided feedback on clinical development plans for the evaluation of Brilacidin as a treatment for COVID-19. IPIX stock is now incorporating this feedback and finalizing the trial protocol for its planned Phase 2, randomized, double-blind, placebo-controlled, multi-national study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19.
The target enrollment for the trial is 120 patients. Contract Research Organizations have been secured to expedite trial enrollment with many clinical sites expressing interest in participating in the study.
Innovation Pharmaceuticals anticipates commencing the Brilacidin for COVID-19 clinical trial in 4Q2020.
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing an established safety and efficacy database on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Ongoing laboratory testing conducted at a U.S. Regional Biocontainment Laboratory (RBL), and at a Public Health Research Institute (PHRI), supports Brilacidin’s antiviral ability to safely inhibit SARS-CoV-2 in both human and animal cell lines.
A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Additional preclinical and clinical data support Brilacidin’s potential to inhibit IL-6, IL-1β, TNF-α, and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients.
Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. These data collectively support Brilacidin as a unique 3 in 1 combination—antiviral, Immuno/anti-inflammatory, and antimicrobial—anti-COVID-19 therapeutic candidate.
Research conducted at George Mason’s Regional Biocontainment Laboratory
At the end of last month, IPIX stock and George Mason University completed extensive laboratory testing supporting the anti-SARS-CoV-2 activity of Brilacidin. The results showed:
- Brilacidin shown in vitro to potently inhibit SARS-CoV-2, the novel coronavirus causing COVID-19.
- In a human lung cell line infected by SARS-CoV-2, Brilacidin achieved a high Selectivity Index of 426.
- The primary mechanism of action of Brilacidin appears to disrupt viral integrity and block viral entry.
- Brilacidin and FDA-approved Remdesivir exhibit excellent synergistic activity in vitro against SARS-CoV-2.
IPIX Stock Bottom Line
We remain bullish on IPIX stock. As we said last month, which can read here, IPIX stock is the cheapest COVID-19 play we have found. Its current market cap is just $83 million compared to $1.5 billion for CytoDyn and $1.1 billion for RLFTF, both of which we have covered here at Insider Financial.
Innovation Pharmaceuticals has been around for so long and its share price depressed that most tend to overlook it, ourselves included. However, we like the data at hand and the potential for the treatment of COVID-19 with Brilacidin and Remdesivir is very compelling. With Gilead, the company behind Remdesivir, sporting a $72 billion market cap, Innovation Pharmaceuticals could be a takeover play as well. The bottom line is that IPIX stock remains a steal at current levels, especially with multiple catalysts coming as the Brilacidin for COVID-19 clinical trial gets underway this quarter.
As always, good luck to all (except the shorts)!
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Disclosure: We have no position in OTCMKTS:IPIX, or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article. Insider Financial is not an investment advisor and does not provide investment advice. Always do your own research and make your own investment decisions. This article is not a solicitation or recommendation to buy, sell, or hold securities. This article is meant for informational and educational purposes only and does not provide investment advice.