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Trial Results

Cellerant Therapeutics Presents Results for CLT-008

June 11, 2018

Cellerant Therapeutics announced results from a randomized controlled Phase II clinical trial of CLT-008 (romyelocel-L, human myeloid progenitor cells), a universal, off-the-shelf cell therapy intended to prevent infections during neutropenia. The Phase II trial was conducted in patients newly diagnosed with acute myeloid leukemia (AML) who underwent induction chemotherapy. Key results of the Phase II study showed that CLT-008 significantly reduced the incidence of serious infections, the number of days in hospital and the use of antimicrobial drugs compared to control. The Phase II study was conducted in patients aged 55 years or older who received either “7+3” (cytarabine and an anthracycline) or “HiDAC” (high-dose cytarabine) induction chemotherapy. A total of 163 patients were enrolled and randomized 1:1 to receive either CLT-008 plus granulocyte colony stimulating factor (G-CSF) (the treated group) or G-CSF alone (the control group). CLT-008 was administered to the treated group approximately nine days after initiation of induction chemotherapy (Day 9), and G-CSF was administered to both groups approximately 14 days after initiation of chemotherapy (Day 14). The study results showed the incidence of serious infection was 76 percent less in the treated group compared to the control group (one sided p = 0.001).

AbbVie’s Upadacitinib Monotherapy Meets Primary and Secondary Endpoints
AbbVie announced positive top-line results from SELECT-EARLY, a Phase III, multicenter, randomized, double-blind, parallel-group, active comparator controlled study. The study was designed to evaluate the safety and efficacy of upadacitinib monotherapy compared to methotrexate monotherapy in adult patients with moderate to severe rheumatoid arthritis who are methotrexate-naïve. In the first phase of the study, patients were randomized 1:1:1 to receive upadacitinib (15 mg or 30 mg, once-daily) or methotrexate. The study showed that both doses of upadacitinib monotherapy (15 mg and 30 mg) met the primary endpoints of ACR50 at week 12 and clinical remission at week 24 versus methotrexate (MTX). Additionally, all ranked secondary endpoints were met. Primary endpoints included ACR50 at week 12 and clinical remission at week 24 for upadacitinib versus methotrexate (superiority). All reported endpoints achieved p-values of <0.001 versus methotrexate for both doses through week 24, except for mTSS for the 15 mg upadacitinib dose at week 24 (p<0.01). At week 12, 76/77 percent of patients receiving 15/30 mg of upadacitinib, achieved ACR20, respectively, compared to 54 percent in the methotrexate group. At week 24, 79/60/44 percent of patients receiving the 15 mg dose of upadacitinib and 78/66/50 percent of patients receiving the 30 mg dose of upadacitinib achieved ACR20/50/70 response, compared to 59/33/18 percent of patients receiving methotrexate. In this study, the safety profile of upadacitinib was consistent with previously reported results from the other SELECT trials in rheumatoid arthritis.

Viking Therapeutics Completes Enrollment in Phase II Study of VK2809
Viking Therapeutics announced that enrollment has been completed in the company’s ongoing Phase II clinical trial of VK2809 in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD). VK2809 is a novel, orally available small molecule thyroid receptor agonist that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promise in this patient population. The Phase II clinical trial is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of VK2809 in patients with elevated LDL cholesterol (LDL-C) and NAFLD. Patients have been randomized to receive once-daily oral doses of VK2809 or placebo for 12 weeks followed by a four-week off-drug phase. The trial’s primary endpoint will evaluate the effect of VK2809 treatment on LDL-C after 12 weeks compared to placebo. Secondary and exploratory endpoints include assessments of changes in liver fat content, triglycerides and other lipid markers. Patients experienced significant reductions in triglycerides, as well as the atherogenic proteins lipoprotein-a and apolipoprotein B. In a Phase Ib study in patients with mild hypercholesterolemia, treatment with VK2809 resulted in placebo-adjusted reductions in low-density lipoprotein ranging from 15 percent to 40 percent.

SCYNEXIS Announces Phase I Study Results for SCY-078
SCYNEXIS announced the results from a Phase I study of SCY-078, assessing the risk for drug-drug interactions when administered with drugs metabolized by the CYP family of enzymes. SCY-078 is currently in development for the treatment of fungal infections caused primarily by Candida. SCY-078 is the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. SCY-078, the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family, is in clinical development for the treatment of multiple serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. In this open-label, two-period, crossover study, results demonstrated that co-administration of rosiglitazone with SCY-078 after repeat dosing had no clinically meaningful effect on rosiglitazone exposure compared with administration of rosiglitazone alone. SCY-078 was well absorbed following the loading dose, and repeated daily doses of rosiglitazone, in the presence and absence of repeat dosing of SCY-078, was generally well tolerated.