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Innovation Pharmaceuticals Signs Agreement for Advanced Oral Tablet Technology in Treating Inflammatory Bowel Disease
BEVERLY, MA – June 6, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, has signed an agreement with BDD Pharma, an award-winning drug delivery company specializing in modified and controlled release oral formulations, to immediately begin the development of tablets for targeted oral delivery of Brilacidin to the colon.
To develop the oral formulation, BDD Pharma will utilize its patented OralogiK™ tablet technology, which employs controlled erosion of a time-dependent barrier layer during small intestine transit to provide effective colon targeting.
BDD’s OralogiK™ technology has been specifically designed to work independently of variations in the GI tract and has shown accurate and consistent performance in clinical studies in several hundred subjects. The unique erosion properties of the technology ensure that when the tablet reaches the colon, the targeted layer has been removed and the drug is rapidly released, maximizing opportunities for therapeutic benefits in the colonic lumen.
The delivery system utilizes well-established manufacturing techniques and excipients which will help to expedite the development of the Brilacidin oral tablet and subsequently maximize return on investment as Brilacidin advances along the regulatory path to market.
Data from the successfully completed clinical trial of Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS) provided evidence of the drug’s effectiveness in safely treating the disease. The Company believes that that the combination of Brilacidin and OralogiK™ will overcome the challenge faced by existing Inflammatory Bowel Disease (IBD) drugs to efficiently and specifically reach the target to deliver the payload. The end goal is to disrupt the market by creating a world-class, affordable small molecule in tablet form as a new treatment option with clear advantages over today’s commonly used biologics for patients with extensive IBD, such as Ulcerative Colitis (UC).
BDD will provide further expertise and resources by collaborating with the Company to accelerate initiation of clinical trials. The trials, evaluating Brilacidin for IBD in tablet form, are targeted to commence later this year or early thereafter.
“BDD Pharma is delighted to sign this agreement with Innovation Pharmaceuticals for a colon-targeted formulation of Brilacidin for treatment of Ulcerative Colitis and other gastrointestinal disease conditions. We are also delighted to be able to engage BDD’s expertise in gamma scintigraphy and early clinical testing to take the Brilacidin program forward expediently into clinical investigation of the new dosage form,“ commented Professor Howard Stevens, Chairman of BDD Pharma.
“BDD’s OralogiK™ technology is transformational, with its unrivaled control of targeted drug delivery attracting significant interest from pharmas, big and small,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We’re confident in the activity of Brilacidin in treating IBD and believe that OralogiK™ will be integral to success in efficiently delivering the drug to the colon. Global pharmaceutical companies have demonstrated a high demand, in deal size and volume, for novel oral IBD drugs—and our goal is to further validate Brilacidin in this space. First-in-human testing using the tablet form should help unlock the tremendous potential in Brilacidin for IBD.”
About Brilacidin for IBD
Inflammatory Bowel Disease (IBD) is a hard-to-treat, chronic, autoimmune condition that affects approximately 10 million people worldwide, including 3 million people in the U.S., with 70,000 newly diagnosed cases each year. The overall GI market sector is estimated to grow from $35.7 billion in 2015 to $48.4 billion by 2022. Brilacidin is being developed as a novel, non-corticosteroid, non-biologic treatment, with formulation plans including oral tablets for Ulcerative Colitis and Crohn’s Disease, and foam and/or gel for mild-to-moderate Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of IBD. As released previously, a majority of patients treated with Brilacidin administered via retention enema achieved Clinical Remission (Modified Mayo scoring) in a Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for UP/UPS. In addition, mucosal healing was evidenced by endoscopic review, an increasingly important measure toward establishing a drug’s efficacy. In late 2018, the Company presented a scientific poster—Brilacidin for Inflammatory Bowel Disease (available for download here, pdf)—at the inaugural “IBD Innovate 2018” conference, hosted by the Crohn’s & Colitis Foundation. Brilacidin may be particularly beneficial in treating IBD due to: its ability to inhibit Phosphodiesterase 4 (PDE4), which is being pursued as a novel therapeutic avenue in IBD; and its potential to compensate for defensin deficiencies that are implicated in the pathogenesis of IBD.
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About BDD
BDD Pharma Ltd is a privately-owned drug delivery company specializing in the development of modified and controlled release oral formulations. BDD’s OralogiK™ technology is a tablet-in-tablet drug delivery system providing timed release, targeted release and the opportunity for complex bi- and tri-phasic release of one or multiple drugs. The OralogiK™ technology is protected with granted patents in the US, EU and Japan. Supported by investment from Archangels and the Scottish Investment Bank, BDD has in-house clinical trial capabilities for the conduct of gamma scintigraphic/ pharmacokinetic studies in humans. BDD Pharma signed two license agreements in 2018 for development of products based on its OralogiKTM technology.
For more information visit http://www.bddpharma.com.
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) 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. 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 Infections. 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. 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, including planned Phase 3 trials of Brilacidin, our future drug development plans, other statements regarding future product developments, and markets, 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 under securities purchase agreements; 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.
Innovation Pharmaceuticals Signs Agreement for Advanced Oral Tablet Technology in Treating Inflammatory Bowel Disease
BEVERLY, MA – June 6, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, has signed an agreement with BDD Pharma, an award-winning drug delivery company specializing in modified and controlled release oral formulations, to immediately begin the development of tablets for targeted oral delivery of Brilacidin to the colon.
To develop the oral formulation, BDD Pharma will utilize its patented OralogiK™ tablet technology, which employs controlled erosion of a time-dependent barrier layer during small intestine transit to provide effective colon targeting.
BDD’s OralogiK™ technology has been specifically designed to work independently of variations in the GI tract and has shown accurate and consistent performance in clinical studies in several hundred subjects. The unique erosion properties of the technology ensure that when the tablet reaches the colon, the targeted layer has been removed and the drug is rapidly released, maximizing opportunities for therapeutic benefits in the colonic lumen.
The delivery system utilizes well-established manufacturing techniques and excipients which will help to expedite the development of the Brilacidin oral tablet and subsequently maximize return on investment as Brilacidin advances along the regulatory path to market.
Data from the successfully completed clinical trial of Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS) provided evidence of the drug’s effectiveness in safely treating the disease. The Company believes that that the combination of Brilacidin and OralogiK™ will overcome the challenge faced by existing Inflammatory Bowel Disease (IBD) drugs to efficiently and specifically reach the target to deliver the payload. The end goal is to disrupt the market by creating a world-class, affordable small molecule in tablet form as a new treatment option with clear advantages over today’s commonly used biologics for patients with extensive IBD, such as Ulcerative Colitis (UC).
BDD will provide further expertise and resources by collaborating with the Company to accelerate initiation of clinical trials. The trials, evaluating Brilacidin for IBD in tablet form, are targeted to commence later this year or early thereafter.
“BDD Pharma is delighted to sign this agreement with Innovation Pharmaceuticals for a colon-targeted formulation of Brilacidin for treatment of Ulcerative Colitis and other gastrointestinal disease conditions. We are also delighted to be able to engage BDD’s expertise in gamma scintigraphy and early clinical testing to take the Brilacidin program forward expediently into clinical investigation of the new dosage form,“ commented Professor Howard Stevens, Chairman of BDD Pharma.
“BDD’s OralogiK™ technology is transformational, with its unrivaled control of targeted drug delivery attracting significant interest from pharmas, big and small,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We’re confident in the activity of Brilacidin in treating IBD and believe that OralogiK™ will be integral to success in efficiently delivering the drug to the colon. Global pharmaceutical companies have demonstrated a high demand, in deal size and volume, for novel oral IBD drugs—and our goal is to further validate Brilacidin in this space. First-in-human testing using the tablet form should help unlock the tremendous potential in Brilacidin for IBD.”
About Brilacidin for IBD
Inflammatory Bowel Disease (IBD) is a hard-to-treat, chronic, autoimmune condition that affects approximately 10 million people worldwide, including 3 million people in the U.S., with 70,000 newly diagnosed cases each year. The overall GI market sector is estimated to grow from $35.7 billion in 2015 to $48.4 billion by 2022. Brilacidin is being developed as a novel, non-corticosteroid, non-biologic treatment, with formulation plans including oral tablets for Ulcerative Colitis and Crohn’s Disease, and foam and/or gel for mild-to-moderate Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of IBD. As released previously, a majority of patients treated with Brilacidin administered via retention enema achieved Clinical Remission (Modified Mayo scoring) in a Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for UP/UPS. In addition, mucosal healing was evidenced by endoscopic review, an increasingly important measure toward establishing a drug’s efficacy. In late 2018, the Company presented a scientific poster—Brilacidin for Inflammatory Bowel Disease (available for download here, pdf)—at the inaugural “IBD Innovate 2018” conference, hosted by the Crohn’s & Colitis Foundation. Brilacidin may be particularly beneficial in treating IBD due to: its ability to inhibit Phosphodiesterase 4 (PDE4), which is being pursued as a novel therapeutic avenue in IBD; and its potential to compensate for defensin deficiencies that are implicated in the pathogenesis of IBD.
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
About BDD
BDD Pharma Ltd is a privately-owned drug delivery company specializing in the development of modified and controlled release oral formulations. BDD’s OralogiK™ technology is a tablet-in-tablet drug delivery system providing timed release, targeted release and the opportunity for complex bi- and tri-phasic release of one or multiple drugs. The OralogiK™ technology is protected with granted patents in the US, EU and Japan. Supported by investment from Archangels and the Scottish Investment Bank, BDD has in-house clinical trial capabilities for the conduct of gamma scintigraphic/ pharmacokinetic studies in humans. BDD Pharma signed two license agreements in 2018 for development of products based on its OralogiKTM technology.
For more information visit http://www.bddpharma.com.
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) 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. 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 Infections. 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. 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, including planned Phase 3 trials of Brilacidin, our future drug development plans, other statements regarding future product developments, and markets, 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 under securities purchase agreements; 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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