Targeting mid-year 2020 to commence clinical trials of Brilacidin for UP/UPS indication
Regulatory documents submitted to health authorities for planned Ulcerative Colitis study
BEVERLY, MA – December 10, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to inform shareholders that Alfasigma S.p.A (“Alfasigma”), the licensee of Brilacidin for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), is targeting mid-year 2020 to commence clinical trials of Brilacidin for the UP/UPS indication.
The Company is encouraged by the pace in which Alfasigma is moving expeditiously forward with clinical development of Brilacidin for UP/UPS. This is important to the Company on multiple levels.
1. Innovation Pharmaceuticals is eligible for up to $24 million in milestone-based payments.
2. Innovation Pharmaceuticals has the potential to receive millions of dollars in revenue annually should Brilacidin reach commercialization.
3. Clinical data from the UP/UPS indication will be added to the growing library of information supportive of Brilacidin as a promising new class of medicine for the treatment of IBD.
As previously disclosed, based upon promising data from the Phase 2 study, the Company licensed rights to develop and commercialize locally-administered Brilacidin (e.g., foam, enema, gel) to Alfasigma, on a worldwide basis, for the treatment of UP/UPS, a clinical manifestation of ulcerative colitis (UC, a type of IBD) affecting the last part of the gastro-intestinal tract, namely the sigmoid and the rectum. The licensing agreement includes upfront cash (received), milestone-based payments and future royalties should the drug be commercialized.
There is a clinical need for a new class of medicine for treating UP/UPS as alternatives to 5-aminosalicyclic acid (5-ASA) and steroid treatments that are commonly used today. The Company believes Brilacidin, the first in a new class of medicine called defensin mimetics, has the potential to fill this need and greatly looks forward to the planned clinical work being conducted by Alfasigma—toward potentially delivering novel UP/UPS treatments to patients and building durable shareholder value.
Update on Ulcerative Colitis Program
Separately, management would like to provide a brief update on the planned independently-sponsored clinical study of Brilacidin for Ulcerative Colitis, a common type of IBD. Last month, Brilacidin was shipped from the drug manufacturer to the Company’s partner, BDD Pharma, for human testing using the delayed-release tablet formulation. Furthermore, the required regulatory paperwork has been submitted to the health authorities for the upcoming study. The Company plans to provide future updates on this trial as appropriate.
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, 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 might be implicated in the pathogenesis of IBD, particularly in Crohn’s disease.
About Alfasigma
Alfasigma is a leading Italian pharmaceutical company, present in more than 90 countries, with a workforce of more than 3,000 people and 5 manufacturing plants around the world. More than 44% of Alfasigma turnover comes from internally developed proprietary products, one of which is XIFAXAN. Alfasigma USA Inc., the American branch of the group, distributes a portfolio of prescription products to help individuals who are suffering from GI disorders (VSL#3®), major depressive disorder (DEPLIN®), diabetic peripheral neuropathy (METANX®), and mild cognitive impairment (CerefolinNAC®). Alfasigma recently acquired ZELNORM™ for the American market of IBS-C. More information is available at the Alfasigma website at: http://www.alfasigma.com/en