Innovation Pharmaceuticals is a small-cap biotech that we have covered here at Insider Financial beginning when it was originally Cellceutix Corp. When the company was Cellceutix, shares traded over $4.50 a share back in 2015. Since then, it’s been a slow bleed for long-suffering shareholders. That’s the bad news. The good news is that Innovation Pharmaceuticals is a steal at current levels.
Innovation Pharmaceuticals is is one of the most promising young biotechs in the sector, yet continues to run foul of short attacks. However, the shorts are about to get their comeuppance now that the company has submitted a pre-IND meeting request to the FDA in advance of a planned study of Brilacidin, a defensin-mimetic drug candidate, for the treatment of COVID-19. In this article, we take a look at the science behind Brilacidon and how we believe it can be a successful treatment for COVID-19.
First up, here’s a little background info for those not familiar with this tiny biotech. Innovation Pharmaceuticals Inc 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 a 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.
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 pre-clinical 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.
U.S. Regional Biocontainment Laboratory (RBL) Results
Back in June, Innovation Pharmaceuticals announced data from ongoing laboratory testing being conducted at a U.S. Regional Biocontainment Laboratory (RBL). The data showed that Brilacidin exhibited a statistically significant (p<0.0001) and potent inhibitory effect on SARS-CoV-2 in a human lung epithelial cell line—reducing viral load by 95 percent and by 97 percent, compared to control, at two therapeutic concentrations tested. Based on a CC50 value—the concentration of drug at which 50 percent of cells maintain viability—Brilacidin was also shown to be non-cytotoxic in the lung cell line.
The new lung cell line data reinforce previous testing conducted at the RBL, in VERO cells, where Brilacidin showed a similar robust inhibition, of 75 percent, against SARS-CoV-2 compared to control. Brilacidin has also been shown, in testing at the RBL, to be non-cytotoxic in VERO cells. Innovation Pharmaceuticals CEO Leo Ehrlich said:
“Brilacidin has now demonstrated potent inhibition of SARS-CoV-2 in human lung and kidney cell lines, and in VERO cells, in laboratory testing conducted by independent academic researchers at two institutions, both of whom plan to submit their findings for peer-review publication. The antiviral data we are compiling provides compelling proof of Brilacidin’s impressive ability to inhibit the novel coronavirus, toward initiating a clinical study of Brilacidin for COVID-19.”
Brilacidin and Remdesivir
In human lung epithelial cell line experiments performed at the RBL, Brilacidin in combination with Remdesivir, compared to Remdesivir-only treated conditions, showed a statistically significant and synergistic inhibition of SARS-CoV-2. Of particular note, overall viral load was reduced by 99.85 percent in one combination experiment, with remaining virus dropping to near undetectable levels.
Brilacidin appears to have primarily an extracellular mechanism of action, by disrupting viral integrity and blocking viral entry. In contrast, Remdesivir—currently authorized by the FDA for emergency use against COVID-19—has an intracellular mechanism of action, affecting viral replication post-infection. Exhibiting different but synergistic antiviral properties, these two drugs may be an especially potent drug combination in treating COVID-19. CEO Leo Ehrlich said:
“The Brilacidin and Remdesivir in vitro combination results are compelling. As we prepare to initiate our own clinical testing of Brilacidin for COVID-19 as a standalone therapy, given its consistent and robust antiviral activity, these latest test results indicate that combination trials with other drugs may be warranted. To that end, the company is pursuing grant opportunities with potential for larger, government-funded clinical trials. Such trials might include options for administration of Brilacidin in combination with Remdesivir, the world’s leading frontline COVID-19 treatment.”
Pre-IND Meeting Request
Last week, Innovation Pharmaceuticals submitted a pre-IND meeting request to the FDA in advance of a planned study of Brilacidin for the treatment of COVID-19. The request for the pre-IND meeting follows the FDA guidance issued in May 2020, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products.” Confirmation of the meeting being granted by FDA, with return of written responses, has been received.
In the application, the Company has requested regulatory guidance on its planned Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin in hospitalized patients with COVID-19. Target enrollment is 120 patients, with a planned interim analysis.
Extensive pre-clinical research, nearing completion, conducted at independent laboratories reinforces the antiviral potential of Brilacidin against SARS-CoV-2, the novel coronavirus responsible for COVID-19. Numerous hospitals and provider networks domestically and abroad have expressed a strong interest in participating in the Brilacidin for COVID-19 clinical trial. Given such interest in Brilacidin, the Company anticipates the planned COVID-19 trial can be rapidly recruited and completed.
Innovation Pharmaceuticals Bottom Line
Innovation Pharmaceuticals is the cheapest COVID-19 play we have found. Its current market cap is just $75 million compared to $1.7 billion for CytoDyn and $1.4 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 treatment of COVID-19 with Brilacidin and Remdesivir is very compelling. With Gilead, the company behind Remdesivir, sporting a $79 billion market cap, Innovation Pharmaceuticals could be a takeover play as well. Shares of IPIX might not remain depressed for much longer.
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.