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Trial Results

Novan’s SB208 Antifungal Program Presents Positive Phase II Results

January 22, 2018

Novan announced Phase II efficacy and safety data for SB208, a topical, silicone-based gel under development for the treatment of fungal infections of the skin and nails. In a Phase II double-blinded, randomized, vehicle-controlled, dose-ranging clinical trial, the tolerability, safety and antifungal activity of SB208 was evaluated in 222 patients with clinical signs and symptoms of tinea pedis, or Athlete’s Foot. Patients were randomized evenly to one of three active or vehicle treatment arms, applying either SB208 Gel (2%, 4% or 16%) or vehicle once-daily for two weeks, followed by a four-week post-treatment observation period. In the primary efficacy analysis of subjects with evaluable culture results, 61.3% (p=0.209) of patients treated with SB208 2%, 80.6% (p=0.002) of patients treated with SB208 4% and 74.2% (p=0.016) of patients treated with SB208 16% achieved negative fungal culture at day 14 versus 45.5% of patients treated with vehicle. The percentage of patients achieving mycological cure at the day 14 visit was 34.4% (p=0.305) of the patients treated with SB204 2%, 50.0% (p=0.009) of the patients treated with SB208 4% and 53.1% (p=0.010) of patients treated with SB208 16% versus 23.5% of patients treated with vehicle. At day 42, the highest mycological cure rates were observed in 58.8% of patients treated with SB208 16% (p=0.020 compared to vehicle).  The percentage of patients achieving clinical cure at day 42 was 14.3% of the patients treated with SB208 2%, 29.7% of the patients treated with SB208 4% and 25.0% of patients treated with SB208 16% versus 14.3% of patients treated with vehicle. The overall incidence of adverse events was low (nine subjects or 4%) and similar in all groups. None of the treatment emergent adverse events were determined to be related to the study medication, and no patients discontinued treatment or dropped out of the study due to an adverse event. Based on the positive data generated in this SB208 Phase II dose-ranging trial, Novan intends to evaluate potential partnerships to advance the antifungal candidate into later stages of development.

RedHill Biopharma Announces Final Results From Phase II Study With BEKINDA for IBS-D

RedHill Biopharma reported top-line final results from the Phase II clinical study with BEKINDA 12mg (RHB-102) for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). An independent review and analysis of the final results, provided to the company, confirmed that the Phase II study with BEKINDA 12mg successfully met its primary endpoint, improving the primary efficacy outcome of stool consistency (per FDA guidance definition) by an absolute difference of 20.7% vs. placebo (p-value=0.036). The final top-line results improve upon the previously announced top-line results (absolute difference of 19.4%, p-value=0.05). Results from the BEKINDA Phase II study suggest that they compare favorably with previously reported efficacy outcome values from studies of Xifaxan (rifaximin) and Viberzi (eluxadoline) across all three efficacy endpoints. The randomized, double-blind, placebo-controlled Phase II study evaluated the efficacy and safety of BEKINDA 12mg in 126 subjects over 18 years old in the U.S., who received either BEKINDA 12 mg or placebo, once daily, for a period of eight weeks. RedHill plans to meet with the FDA in the first half of 2018 to discuss the design for one or two pivotal Phase III studies with BEKINDA 12mg for IBS-D.

BioLineRx Announces Partial Monotherapy Results From Phase IIa COMBAT Study

BioLineRx announced partial results from the monotherapy portion of BL-8040’s Phase IIa COMBAT study showing that BL-8040 increases infiltration of T cells into the tumor in patients with metastatic pancreatic cancer. The Phase IIa study, named the COMBAT study, is an open-label, multicenter, single-arm trial designed to evaluate the safety and efficacy of the combination of BL-8040 and KEYTRUDA (pembrolizumab) in over 30 subjects with metastatic pancreatic adenocarcinoma. The partial results from the BL-8040 monotherapy portion of the COMBAT trial show that BL-8040 was safe and well-tolerated. BL-8040 also induced an increase in the number of total immune cells in the peripheral blood, while the frequency of peripheral blood regulatory T cells (Tregs), known to impede the anti-tumor immune response, was decreased. In addition, analysis of available biopsies (n=7) showed infiltration of various types of effector T cells, known to attack cancer cells, into the tumor periphery and tumor micro-environment (TME). In this regard, the results show up to a 15-fold increase in CD3+ T cells, and up to a two-fold increase in CD8+ T cells, in the TME of 43% (3/7) of the patients, after five days of BL-8040 monotherapy.