· Convened first Joint Development Committee (JDC) meeting
· Data generated to inform internal Brilacidin development efforts in Ulcerative Colitis
· Goal to develop oral Brilacidin to treat a wide continuum of GI diseases in GI market estimated to hit $48.4 Billion by 2022
· Brilacidin tablet for UC clearly differentiated as oral, non-biologic, non-corticosteroid, targeted UC drug candidate
BEVERLY, MA – October 14, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce positive momentum in its efforts to advance programs utilizing Brilacidin for Inflammatory Bowel Disease (IBD). The Company’s goal is to develop Brilacidin as a novel, non-corticosteroid, non-biologic orally-delivered drug capable of treating a wide continuum of GI diseases, to the benefit of patients and shareholders alike.
The first Joint Development Committee (JDC) meeting with Alfasigma S.p.A.—an Italy-based global pharmaceutical company that licensed worldwide rights to develop Brilacidin for localized treatment in Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS)—was recently convened. The JDC is responsible for reviewing, discussing and approving activities related to advancing Brilacidin in UP/UPS. There is a great need for novel treatments capable of achieving remission in distal colitis via enema, as evidenced by Food and Drug Administration (FDA) registration trials for Salix Pharmaceutical’s UCERIS®, a corticosteroid that showed 2mg rectal foam (foam enema) achieved modest remission rates of distal colitis at six weeks. Salix was acquired by Valeant Pharmaceuticals in 2015 for $14.5 billion.
Alfasigma, with proven expertise in treating IBD and substantial commercial capabilities, is well-positioned to advance Brilacidin toward regulatory approval in UP/UPS, a $1.4 billion market with the current standard-of-care comprising 5-aminosalicyclic acid (5-ASA) and steroid treatments. If successful, milestone-based payments totaling $24 million, plus royalties, would be paid to Innovation.
Through strategic partnering with BDD Pharma, preparations continue for initiation in December of a planned Phase 1 clinical trial of oral Brilacidin in the Ulcerative Colitis (UC) program. Data generated under this partnership in UP/UPS will help inform ongoing internal development efforts of Brilacidin in Ulcerative Colitis (UC). The Company is transitioning to targeted oral delivery of Brilacidin, in tablet form, to the colon in collaboration with BDD Pharma, Innovation’s oral formulation development partner in IBD. The planned Phase 1 clinical trial of oral Brilacidin in healthy volunteers, part of the Company’s larger UC program, is anticipated to commence in December. The worldwide UC market was valued at $6.85 billion in 2018, with a Compound Annual Growth Rate of 4.86 percent expected thru 2024.
More broadly, renewed interest in the larger Gastrointestinal market sector—estimated to grow from $35.7 billion in 2015 to $48.4 billion by 2022—is based on shortcomings in current treatment regimens. According to a recent study, almost 15 percent of patients with IBD showed evidence of excessive steroid use or dependency. Anti-TNF agents (or biologics) can have high initial treatment failure rates and loss-of-response rates. Treatment non-adherence also occurs in up to 50 percent of IBD patients. New therapies, particularly ones that are well-tolerated and can be orally-delivered, as patients prefer, are highly sought after. Significant premiums are being paid for novel oral IBD treatments in development—whether via lucrative licensing agreements (e.g., Janssen and Theravance Biopharma, Janssen and Protagonist Therapeutics), or via direct investments from venture capital (e.g., Xontogeny and Landos BioPharma).
“Building on our out-licensing agreement in UP/UPS, the objective of our planned clinical trial to begin in December is to demonstrate the selective release of Brilacidin to the colon, via oral tablet. A successful outcome would represent a significant breakthrough in Brilacidin’s development, separating it from other drug candidates in IBD, a substantial and prized market with a large unmet patient need,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “We look forward to updating shareholders about our Brilacidin program in UC as milestones occur.”
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 enema, 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: 1) its ability to inhibit Phosphodiesterase 4 (PDE4), which is being pursued as a novel therapeutic avenue in IBD; and 2) its potential to compensate for defensin deficiencies that are implicated in the pathogenesis of IBD.