Cellceutix (CTIX) Announces Clinically Meaningful Data from Brilacidin in UP/UPS

October 10, 2016 7:04 AM EDT
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Cellceutix Corporation (OTC: CTIX) announced interim results observed for the first four patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), a type of Inflammatory Bowel Disease (IBD). Clinically meaningful improvements were demonstrated, as measured by physician assessments, patient reported outcomes and endoscopic evaluation of disease activity.

The ongoing Phase 2, open-label, proof-of-concept trial comprises three sequential cohorts (6 patients per cohort), with progressive dose escalation by cohort—50 mg, 100 mg, and 200 mg, respectively. Treatment with Brilacidin by daily enema administration is performed for 42 days.

Four (4) of 6 patients to date in the lowest dosing cohort (50 mg) have completed the study. Comparison to baseline after 6 weeks of treatment showed:

  • All 4 patients experienced a clinically meaningful response, as measured by the Modified Mayo Disease Activity Index (MMDAI).
    • At Day 42, on the Partial MMDAI (accounting for Stool Frequency, Rectal Bleeding, and Physician’s Global Assessment scores), 2 of 4 patients achieved full response (100% reduction) and the other 2 patients had notable improvement (50% reduction).
    • At Day 42, on the MMDAI (equivalent to Partial MMDAI + Endoscopy score; completed by 3 of 4 patients), 1 of 3 patients achieved full response (100% reduction) and 2 of 3 patients had notable improvement (50% reduction). One patient who had demonstrated a full response on the Partial MMDAI (as defined in first bullet point) did not consent to the final endoscopy, so their data cannot be included in these initial results.
  • Patient quality of life, as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), was improved after 6-weeks of treatment with Brilacidin.
  • Brilacidin was generally well-tolerated and patients maintained stable normal vital signs during treatment.

For all 4 patients, measurements of drug concentrations in plasma showed all levels, across all time points, to be below the lower limit of quantification (i.e., <100 ng/mL), which is consistent with very limited systemic exposure from administration per rectum by enema. In comparison, based on a previously completed and successful Phase 2b clinical trial of Brilacidin in the treatment of serious skin infections, maximum concentrations of the drug in plasma administered by intravenous (iv) dosing, ­­at 0.6 mg/kg and 0.8 mg/kg, were approximately 9,000 ng/mL and 12,000 ng/mL, respectively.

“These results are extremely encouraging. They support early clinical validity of the unique immunomodulatory properties of Brilacidin. We anticipate the anti-inflammatory properties of Brilacidin alone will lead to multiple beneficial applications of the drug candidate beyond its already demonstrated effect in antibacterial indications,” said Arthur P. Bertolino, MD, PhD, MBA, Cellceutix President and Chief Medical Officer.

Leo Ehrlich, Chief Executive Officer of Cellceutix, commented: “We are delighted to see such promising responses to treatment in the first group of patients given the lowest dose of Brilacidin. The open label design of this trial allowed us to take an early look. Inflammatory Bowel Disease, which affects millions worldwide, poses a real medical need for patients who we hope may eventually benefit from our lead defensin mimetic drug candidate. The immunomodulatory and anti-inflammatory properties are at the core of effectively treating many diseases and conditions, such as IBDs and oral mucositis. As we are initiating 2-3 more sites to our ongoing oral mucositis (OM) trial this month and continue to report results from this UP trial, we expect to continue to grow many horizontal and vertical pipeline opportunities with the Brilacidin franchise.”

Continued reporting of results from this ongoing Phase 2 proof-of-concept clinical trial is anticipated over the coming months.

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