Study to help guide Cellceutix in continued development of Brilacidin, including planned foam and oral formulations for hard-to-treat chronic conditions like Ulcerative Colitis and Crohn’s Disease
BEVERLY, MA – March 16, 2017 (GLOBE NEWSWIRE) Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to inform shareholders that, next week, the Company will be providing additional detailed data from its ongoing Phase 2a Proof-of-Concept (PoC) study of Brilacidin for the treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).
While advances in IBD treatment—specifically, the approval of Tumor Necrosis Factor (TNF) inhibitors—now offer patients more effective therapeutic options, biologics have major drawbacks. In addition to their high costs and the risk of serious side-effects is the potential loss of therapeutic response. One-third of patients on biologics lose response over time, often needing to be switched to another TNF inhibitor, and another one-third of patients fail to respond to TNF inhibitors at all. Moreover, management of IBD is moving from alleviation of symptoms toward long-term control of Gastrointestinal (GI) inflammation (preventing disease progression and recurrence). Avoiding initial treatment failure, which can cost an average of $11,500 per patient, and achieving sustained clinical remission, increasingly is a realistic goal for managing patients with IBD.
In short, there exists a large unmet need in treating IBD patients with newer, non-biologic therapies, which we believe Brilacidin, with its unique mechanism of action, is showing the potential of becoming.
Following the information released on March 8, 2017, disclosing preliminary efficacy and safety data as part of interim analysis from the first two cohorts (12 patients) in the UP/UPS trial, Cellceutix has received numerous requests from various interested parties to provide added context on Brilacidin and its potential in IBD. In the upcoming data release, we plan to provide further scope and breakdown of study results across the first two cohorts, along with other insights based on results observed to date. This summer, Cellceutix plans to present both topline findings from the complete Brilacidin-UP/UPS trial as well as interim data from its ongoing Phase 2 trial of Brilacidin for Oral Mucositis at Drug Discovery and Therapy World Congress 2017 to be held July 10 – 13, 2017 in Boston. More details to come.
“We have received excellent results, to date, in our Brilacidin IBD trial, both regarding objective scores and subjective assessments. The systemic absorption of Brilacidin has been minimal while still yielding compelling patient responses,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Cellceutix. “We’re getting exactly what we need from a proof-of-concept study—clear and strong signals both as to the safety and the efficacy of Brilacidin in treating IBD. These results will help guide the continued development of Brilacidin, including planned foam and oral formulations, for hard-to-treat chronic conditions like Ulcerative Colitis and Crohn’s Disease.”
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Brilacidin is Cellceutix’s 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, Cellceutix 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: 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 Infections (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and a potential extra 5 years of United States market exclusivity upon drug approval.
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About Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD), with Ulcerative Colitis (UC) and Crohn’s Disease (CD) the most common forms, are lifelong, chronic conditions characterized by inflammation of the gastrointestinal (GI) track with symptoms fluctuating between periods of exacerbation and remission. The peak age for UC onset is between 30 and 40 years and between 20 and 30 years for CD. Approximately 20 percent of patients with UC experience active “moderate” or “severe” disease and 50 percent are in remission. Seventy percent of those with active disease of any severity and 30 percent of those in remission will experience episodes in the following year. In CD, 55 percent of patients in remission will have a relapse across the next year, with 11 percent having chronically active disease. Approximately 1.7 million people in the U.S. have IBD, with the total number of cases increasing by 70,000 cases annually. IBD greatly affects a person’s quality of life, including increased emotional distress and a reduced ability to work. Total societal costs, in the U.S. alone, attributable to IBD are estimated to range between $14.6 and $31.6 billion. The considerable economic burden of IBD makes an accurate diagnosis, coupled with effective treatment at the onset of symptoms, a critical component of IBD care.
Ulcerative Proctitis (UP), a limited type of Ulcerative Colitis (UC), is a mucosal inflammatory disease of unknown cause involving only the rectum. When it involves both the rectum and the distal colon, it is called Ulcerative Proctosigmoiditis (UPS). It is characterized by inflammation, redness, and ulcerations of the mucosa. The course of the disease is variable and ranges from complete resolution to easily maintained remission to chronic relapses or refractory disease. Diagnosis can occur at any point in life, with approximately 30-50 percent of patients developing more extensive UC. There is currently no cure. According to estimates provided by GlobalData, the worldwide UC market, which includes products for UP/UPS, is expected to increase at a compound annual growth rate of 4.7 percent, from $4.2 billion in 2012 to approximately $6.6 billion by 2022.
About Cellceutix’s Proof-of-Concept (PoC) UP/UPS Trial Design
This trial is being conducted in an overseas hospital/clinic setting with Brilacidin being administered with water in an enema. A foam formulation of Brilacidin for use in future studies is planned and would be expected to improve patient convenience and study results. The primary objective of Cellceutix’s Proof-of-Concept (PoC) trial is to assess the frequency of clinical remission (defined using Modified Mayo Disease Activity Index [MMDAI] scoring) with Brilacidin administered per rectum by enema in patients with active UP or UPS after 6 weeks of treatment. Secondary objectives include: evaluation of safety and tolerability of Brilacidin when administered per rectum; assessment of systemic exposure and/or pharmacokinetics of Brilacidin when administered per rectum; assessment of the efficacy of Brilacidin by change in MMDAI at Day 42/Week 6 and Partial MMDAI during treatment and by biomarker evaluation (from serum, feces, and rectum/sigmoid biopsy samples); evaluation of change in patient-reported quality of life (by the Short Inflammatory Bowel Disease Questionnaire); and estimation of statistical power for subsequent trial(s) in UP and UPS. The PoC trial includes 18 patients divided evenly into three cohorts. Cohort A receives 50 milligrams (mg) of Brilacidin once daily administered per rectum as a retention enema for 42 days. Dosing is increased to 100 mg and 200 mg once daily for 42 days for Cohort B and Cohort C, respectively. Endoscopic evaluation of the rectum and mucosa up to 40 cm from the anal verge is performed at screening and at the end of treatment/Day 42 (± 3 days). Per protocol, a Safety Committee reviews safety and retention data (clinical laboratory findings, vital signs, adverse events, retention times) after 21 days of therapy for all six patients in each cohort before proceeding with initiating enrollment into the subsequent cohort.