BIIB's Alzheimer's Drug Scores Well, EXAS Heads Higher, VXRT Down But Not Out

pharma daily 051718

Today's Daily Dose brings you news about Eisai/Biogen's phase II study of Elenbecestat in Alzheimer's disease; Exact Sciences' newly identified biomarker panel; Ironwood Pharma's updated data from phase IIb trial of IW-3718 in persistent gastroesophageal reflux disease; Summit Therapeutics' near term catalyst, and Vaxart's disappointing trial results of antiviral Teslexivir 5% gel for the treatment of condyloma, or anogenital warts.

Read on…

Eisai Co. Ltd. and Biogen Inc.'s (BIIB) phase II clinical study of Elenbecestat in patients with mild cognitive impairment due to Alzheimer's disease, or mild to moderate dementia due to Alzheimer's disease with confirmed amyloid pathology by PET screening, dubbed Study 202, has demonstrated promising results.

At 18 months, there was a statistically significant difference in amyloid beta (Aß) levels in the brain measured by amyloid-PET (positron emission tomography). Elenbecestat also demonstrated acceptable safety and tolerability profile.

However, in the study, CDR-SB (Clinical Dementia Rating Sum of Boxes), an exploratory endpoint to assess efficacy in terms of clinical symptoms, showed numerically less decline for the Elenbecestat 50 mg total arm compared to placebo, which was not statistically significant.

The study was not powered to show statistical significance compared to placebo on clinical symptoms.

BIIB closed Tuesday's trading at $298.64, down 0.09%.

During a presentation on Tuesday at Digestive Disease Week, Exact Sciences Corp. (EXAS) and Mayo Clinic researchers announced that they have identified blood-based, DNA biomarker panel that could accurately detect hepatocellular carcinoma.

The biomarker panel was shown to be 95 percent sensitive for detecting HCC across all stages. Sensitivity among patients with curable-stage disease was 91 percent. The panel has overall specificity of 93 percent, demonstrating its ability to discriminate between normal and diseased patients.

Cologuard, the stool-based, advanced-DNA screening test for colorectal cancer, is also the result of collaboration between Exact Sciences and Mayo Clinic.

EXAS closed Tuesday's trading at $62.46, up 3.14%. In after-hours, the stock was up 4.95% to $65.55.

Ironwood Pharmaceuticals Inc. (IRWD), on Tuesday, presented data from a double-blind, placebo-controlled, dose-ranging Phase IIb trial of IW-3718 in persistent gastroesophageal reflux disease - building upon previously reported topline positive results from the trial.

The data demonstrated that, compared to placebo, IW-3718 1500 mg plus a once a day proton pump inhibitor (PPI) improved symptoms of heartburn severity in the overall population of GERD patients in the trial. Additionally, new data presented suggested a greater improvement in heartburn severity in the subset patient population of persistent GERD patients who also have erosive esophagitis, a severe inflammation and erosion of the esophagus.

Following the positive Phase IIb results, the Company expects to advance IW-3718 into phase III trials during the third quarter of 2018.

IRWD closed Tuesday's trading at $17.44, down 1.80%.

Summit Therapeutics plc (SMMT) has an important catalyst coming its way this year.

The Company expects to report top-line 48-week data from the PhaseOut DMD trial in Q3, 2018.

The PhaseOut DMD study is a phase II trial evaluating Ezutromid in Duchenne muscular dystrophy. The Company announced positive 24-week interim data from the PhaseOut DMD trial in January of this year.

Summit expects to initiate its phase III clinical trials of Ridinilazole for C. difficile infection in Q1 2019, and initiate a lead preclinical gonorrhoea candidate in H2 2018.

SMMT closed Tuesday's trading at $13.26, down 2.50%.

Therapix Biosciences Ltd. (TRPX) has enrolled the first subject in its phase IIa, sponsor-initiated clinical trial of its cannabinoid-based technology THX-110 for Obstructive Sleep Apnea at Assuta Medical Center in Israel.

The clinical trial is designed to enroll 30 subjects who will receive one daily treatment of the drug THX-110 via oral administration and is followed-up for one month.

TRPX closed Tuesday's trading at $4.33, down 4.63%.

Shares of Vaxart Inc. (VXRT) plunged more than 20% on Tuesday, following disappointing efficacy results from the Company's phase II trial of antiviral Teslexivir 5% gel for the treatment of condyloma, or anogenital warts.

According to the trial results, 30.6% of patients in the Teslexivir group completely cleared baseline condyloma by week 16, compared to 23.3% of patients in the placebo group. But the difference was not statistically significant.

Commenting on the study results, Wouter Latour, chief executive officer of Vaxart, said, "While this trial did not achieve the primary efficacy endpoint, we were pleased with the benign safety profile and positive efficacy trends in certain patient subpopulations. We are currently in the follow-up phase of the study and data collection should continue for a few more weeks. During this period, we will conduct further analysis of the results, which should inform us about the future steps with the teslexivir program".

VXRT closed Tuesday's trading at $3.26, down 23.83%. In after-hours, the stock was up 2.98% to $3.46.

Viking Therapeutics Inc. (VKTX) has completed enrollment in its ongoing Phase 2 clinical trial of VK2809 in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD).

The Company expects to announce results from this trial in the second half of 2018.

VKTX closed Tuesday's trading at $9.39, up 0.64%.

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