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Latest New Medical Therapy Trial Results

Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results are also searchable by therapeutic area beginning with the most recent updates.

Week of June 26, 2017

Indivior issued results of a phase III trial of RBP-6000 for moderate to severe opioid use disorder (OUD) as part of a complete treatment plan to include counseling and psychosocial support. A total of 504 treatment-seeking adults, aged 19 to 64 with moderate or severe OUD (not currently receiving medication-assisted treatment, or MAT) were randomized to either one of two dosage regimens of RBP-6000 (n=404) or placebo (n=100). Prior to randomization, subjects were inducted and dose-stabilized onto transmucosal buprenorphine-containing product according to the prescribing information to suppress opioid withdrawal signs and symptoms and ensure lack of allergy to buprenorphine. Randomized subjects received six once-monthly 300mg doses (300/300mg), two once-monthly 300mg doses followed by four once-monthly 100mg doses (300/100mg) or six once-monthly subcutaneous injections of placebo. The results showed that RBP-6000 met the primary efficacy endpoint, with both RBP-6000 dosage regimens demonstrating abstinence rates that were significantly higher versus placebo (300/300mg: 41.3%; 300/100mg: 42.7%; placebo: 5.0%, p<0.0001). Both RBP-6000 dosages also met the key secondary endpoint of treatment success (300/300mg: 29.1%; 300/100mg: 28.4%; placebo: 2.0%, p<0.0001). In addition to the efficacy findings, a pharmacokinetic-pharmacodynamic (exposure-response) analysis demonstrated a positive relationship between buprenorphine exposure, mu-opioid receptor occupancy and clinical endpoints of abstinence, withdrawal symptoms and opioid craving. Significantly more subjects in both RBP-6000 dosage groups completed the study compared with those on placebo (300/300mg: 64.3%; 300/100mg: 61.3%; placebo: 33.3%, p<0.0001). RBP-6000 was generally well-tolerated, though 2.7% of subjects on RBP-6000 (both dosage regimens combined) experienced a serious treatment-emergent adverse event (TEAE) compared with 5.0% of subjects on placebo. There were no related serious TEAEs across groups. Indivior submitted a New Drug Application (NDA) to the FDA to seek marketing approval for RBP-6000 for the treatment of adults with moderate to severe OUD as part of a complete treatment plan to include counseling and psychosocial support.

RedHill Biopharma reported results of a phase III study of Bekinda (RHB-102) 24mg for acute gastroenteritis and gastritis. The randomized, double-blind, placebo-controlled GUARD study enrolled 321 adults and children over the age of 12 at 21 clinical sites in the U.S. and randomized in a 60:40 ratio to receive either Bekinda 24mg or placebo, respectively. The primary endpoint of the study was the proportion of patients without further vomiting, without rescue medication and who were not given intravenous hydration from 30 minutes post first dose of the study drug until 24 hours post dose, compared to placebo. Top-line results indicated that the phase III GUARD study successfully met its primary endpoint in the Intent to Treat (ITT) population (p=0.04), despite high positive outcome rate in the placebo arm. Bekinda improved the efficacy outcome by 21%; 65.6% of Bekinda-treated patients as compared to 54.3% of placebo patients (p=0.04; n=192 in the Bekinda group and n=129 in the placebo group). Correcting for a randomization error, the difference in effect is greater with 65.8% vs. 53.9% favoring Bekinda vs. placebo in reaching the primary endpoint of the study (p=0.03). In per-protocol (PP) analysis of patients who met all protocol entry criteria and for which the diagnosis of gastroenteritis was confirmed (n=177 in the Bekinda group and n=122 in the placebo group), Bekinda improved the efficacy outcome by 27%; 69.5% of patients in the Bekinda group vs. 54.9% in the placebo group (p=0.01). The study successfully met its primary endpoint of efficacy in treatment of acute gastroenteritis. Bekinda was found to be safe and well-tolerated in this indication. 

Xencor reported results of a phase II trial of XmAb5871 in patients with active IgG4- related disease (IgG4-RD). As of a data cutoff, all 15 planned patients with active IgG4-RD have been enrolled and dosed with XmAb5871 (median number of infusions=12, range five to 12). Patients had a median IgG4-RD RI of 12 (range two to 30) with a median of five organs involved (range one to 10) at the time of study entry. Fourteen of the 15 patients (93%) dosed with XmAb5871 have had a response to XmAb5871 therapy of greater than or equal to a two-point reduction in the IgG4-RD RI (protocol defined response), 12 of them within two weeks of the first dose. At two weeks following the last dose, five patients had an IgG4-RD RI of zero and were on no corticosteroid therapy between months two to six (protocol definition of remission). In addition, a sixth patient achieved remission in the post-therapy follow-up period. All five of the patients that either entered the study on corticosteroids or that were administered corticosteroids at the beginning of the study have been able to taper and discontinue corticosteroids within two months of the start of the study. Organ site involvement occurring at a frequency of greater than or equal to 45% included lymph nodes, submandibular glands, parotid glands and lacrimal glands. In addition, 40% of patients suffered from constitutional symptoms at time of study entry. Every other week intravenous administration of XmAb5871 has been well-tolerated. Adverse events (AEs) were consistent with that previously reported, with all XmAb5871-related AEs graded as mild or moderate and no AE reported in more than two patients. No severe AEs deemed related to XmAb5871 were reported. One patient discontinued the study as the result of an AE of a moderate hypersensitivity reaction.

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