Innovation Pharmaceuticals Phase 2b Psoriasis Study On-Track for Completion in December 2017; Company a Sponsor at Upcoming Symposium on Hidradenitis Suppurativa
BEVERLY, Mass., Oct. 31, 2017 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals Inc. (IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report continued developments in its dermatology franchise.
The Company’s randomized, placebo-controlled Phase 2b clinical trial of Prurisol for chronic, moderate-to-severe plaque psoriasis (see NCT02949388), enrolling a total of 199 patients, remains on-track for completion in December. Separately, building upon promising results seen to date demonstrating its anti-inflammatory, anti-infective and immunomodulatory properties, the Company is looking to expand Brilacidin into treating multiple serious chronic skin diseases. The Company plans to participate in upcoming dermatology conferences, including as a sponsor in this week’s Symposium on Hidradenitis Suppurativa Advances to be held November 4-5, 2017, in Detroit, MI.
Brilacidin’s potential application in dermatology to provide improved treatment options for people in need is discussed below.
From a scientific perspective, defensins—which Brilacidin was designed to mimic—play an important and multifunctional role in regulating the skin micro-environment. The increased susceptibility of people with Atopic Dermatitis (Eczema) to S. aureus infections, significantly complicating this skin condition and against which Brilacidin has been shown to have potent efficacy, is thought to be influenced by the impaired expression of Host Defense Proteins (HDPs). Up to a combined 50 million people, in the U.S. and major European markets, are affected by Eczema. Brilacidin also exhibits strong anti-inflammatory effects on key effector cells involved in the etiology of Hidradenitis Suppurativa (HS), a burdensome skin disease affecting 1 to 4 percent of the world’s population, and for which there currently is only one approved marketed treatment (Humira). Brilacidin’s antimicrobial and wound healing properties might similarly benefit HS sufferers. Pre-clinical lab work also indicates impressive Minimum Inhibitory Concentration (MIC) values when Brilacidin was tested against Propionibacterium spp.—a type of bacteria expressed in Acne—compared to other antibiotics, such as Erythromycin, Clindamycin, Minocycline, Doxycycline and Metronidazole.
One key aspect of Brilacidin’s Mechanism of Action, inhibiting Phosphodiesterase 4 (PDE4), might also contribute to its therapeutic potential in treating skin diseases.
Linked below is additional information, published on the Company’s website, elaborating on Brilacidin’s treatment potential in various dermatological conditions.
“Brilacidin’s Potential Application in Dermatology” www.ipharminc.com/new-blog/2017/6/5/brilacidins-potential-application-in-dermatology
Acting through immune modulation and PRINS reduction, Prurisol is a novel dermatology compound currently in mid-stage development as an oral psoriasis treatment utilizing the advantages of the FDA's 505(b)(2) development approach. This regulatory approach helps expedite a drug candidate’s approval as it allows the FDA to rely, in part, on existing clinical data from an already approved drug, in this instance, Ziagen. In laboratory studies, Prurisol was found to be effective against psoriasis in animal models, both in induced psoriasis and in a xenograft model using human psoriatic tissue. In these models, Prurisol eliminated virtually all signs of psoriasis. Innovation Pharmaceuticals has successfully completed a Phase 2 clinical trial of Prurisol in patients with mild-to-moderate chronic plaque psoriasis. Overall analyses showed that the drug candidate appears to be safe, well-tolerated and demonstrated early efficacy in the highest dosing arm across 12 weeks of treatment. Patients with moderate psoriasis saw the greatest clinical improvements. An early dose-dependent response that improved as treatment duration increased was observed. Innovation Pharmaceuticals has initiated a Phase 2b clinical trial of Prurisol in moderate-to-severe psoriasis and will be assessing the drug candidate’s efficacy at higher dosing regimens.
Brilacidin is Innovation Pharmaceuticals’ lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, the Company is studying Brilacidin’s effect on Oral Mucositis (under Fast Track designation) and on Ulcerative Proctitis / Proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: Atopic Dermatitis, Hidradenitis Suppurativa and Acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and an extra 5 years of United States market exclusivity upon drug approval.
Headquartered in Beverly, Massachusetts, Innovation Pharmaceuticals Inc. (IPI) is publicly-traded under the company symbol “IPIX”. The Company is clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. The Company believes it has a world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. The Company’s Psoriasis drug candidate Prurisol completed a Phase 2 trial and a Phase 2b study is ongoing. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. The Company’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and the Company has commenced a Phase 2 study in Ovarian Cancer. In the laboratory, Kevetrin has been shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Brilacidin, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative Oral Mucositis (OM) by more than 94% compared to placebo. The Company is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of OM in patients with Head and Neck Cancer; interim results have shown a marked reduction in the incidence of severe OM (WHO Grade ≥ 3). The Company’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (“superbugs”). Topline results are now available for the Phase 2, open label Proof-of-Concept trial, treating patients with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). The Company has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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