BEVERLY, Mass., Oct. 24, 2017 (GLOBE NEWSWIRE) — Innovation Pharmaceuticals Inc. (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to provide a development update for Brilacidin as a promising novel, non-corticosteroid, non-biologic treatment for Inflammatory Bowel Disease (IBD).
Following the successful completion of its Phase 2 Proof-of-Concept (PoC) trial in Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), in which a majority of patients treated with Brilacidin achieved Clinical Remission (including Endoscopic Improvement), the Company is making plans to advance the clinical development of Brilacidin-IBD.
Update
Oral formulation plans are underway to deliver Brilacidin more widely throughout the GI tract so as to enable treatment of more extensive forms of IBD—Crohn’s Disease and Ulcerative Colitis. A meeting with the Food and Drug Administration (FDA) is being requested to help inform appropriate next steps for our Brilacidin-IBD program, such as the size and scope of subsequent clinical trials. Finally, the Company plans to continue exploration of Brilacidin’s various mechanisms of action, including its anti-inflammatory and anti-bacterial properties, as well as its immunomodulatory and wound healing capabilities—all of which likely have a role in Brilacidin’s ability to treat IBD. Brilacidin already has been shown to inhibit Phosphodiesterase 4 (PDE4), which has been identified as a novel therapeutic approach in treating IBD. The academic literature further suggests a defensin/mucin deficiency in IBD, indicating Brilacidin may also have an important compensatory effect in this area.
“On the heels of a successful Proof-of-Concept study of Brilacidin in IBD, we look forward to continuing the Company’s momentum in this area,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Given IBD’s complex pathogenesis and variability in patient response to any one drug, new treatments are needed. More broadly, discussions remain ongoing with numerous global pharmaceutical companies, which, like us, see the considerable potential of Brilacidin as a multi-faceted drug candidate, with possible application across multiple therapeutic areas. The beauty of Brilacidin is that it was designed not only to mimic but actually to improve the body’s innate immune response—and that’s exactly what we’re now seeing translate into the clinic in the form of favorable patient outcomes.”
“The results of the Brilacidin distal colitis study are exciting,” noted Dr. Francis A. Farraye, MD, MSc, Clinical Director, Section of Gastroenterology at Boston Medical Center, Professor of Medicine at Boston University School of Medicine and Scientific Advisor to Innovation Pharmaceuticals. “Brilacidin—particularly once formulated for oral delivery, offering broader coverage for more extensive forms of IBD and possibly an even greater therapeutic effect—has the potential to offer GI practitioners a novel, easily-administered therapeutic option for chronic, hard-to-treat Inflammatory Bowel Disease. I am pleased to continue my involvement with the Company as we look to advance Brilacidin into future IBD trials.”
Linked to below is additional information on PDE4-inhibition and defensin-based therapies as promising new treatment approaches in IBD drug development:
- “PDE4 Inhibition and Inflammatory Bowel Disease: A Novel Therapeutic Avenue”
Int. J. Mol. Sci. 2017, 18(6), 1276
http://www.mdpi.com/1422-0067/18/6/1276/htm
- “Deficient Defensins and Missing Mucins in the Pathogenesis of Inflammatory Bowel Disease”
http://www.ipharminc.com/new-blog/2017/10/24/deficient-defensins-and-missing-mucins-in-the-pathogenesis-of-inflammatory-bowel-disease
About Brilacidin
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.
Learn more here:
http://www.ipharminc.com/brilacidin-1
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About the Company
Headquartered in Beverly, Massachusetts, Innovation Pharmaceuticals Inc. (IPI) is publicly-traded under the company symbol “IPIX”. The Company is a 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.
INVESTOR AND MEDIA CONTACT
Innovation Pharmaceuticals
Leo Ehrlich
info@ipharminc.com
