Plus   Neg

ABBV's SELECT-COMPARE Hits Goals, MNLO's ATOMIK Flops, VTVT Down 63% After-Hrs

pharma 041018 lt

Today's Daily Dose brings you news about encouraging results from AbbVie's SELECT-COMPARE study; disappointing results from Menlo's phase II trial of Serlopitant for the treatment of pruritus associated with atopic dermatitis; Tandem's agreement with Movi SpA, and vTv Therapeutics' Alzheimer's disease drug failure.

Read on…

AbbVie's (ABBV) phase III trial of Upadacitinib (15 mg, once-daily) in adult patients with moderate to severe rheumatoid arthritis, dubbed SELECT-COMPARE, has yielded encouraging top-line results.

The ongoing study evaluates the safety and efficacy of Upadacitinib compared to placebo and Humira in adult patients with moderate to severe rheumatoid arthritis who are on a stable background of methotrexate and who have an inadequate response.

According to the study results, at week 12, 71 percent of patients receiving an oral once-daily dose of Upadacitinib 15 mg achieved an ACR20 response compared with 36 percent of patients receiving placebo. A significantly higher proportion of patients receiving Upadacitinib achieved clinical remission compared with placebo at week 12. (29 percent versus 6 percent, respectively).

Additionally, low disease activity based on DAS28(CRP) was seen in 45 percent of patients receiving Upadacitinib compared to 29 percent receiving Humira and 14 percent receiving placebo at week 12, respectively.

SELECT-COMPARE is the fourth of six phase III studies in the SELECT rheumatoid arthritis clinical trial program.

AbbVie plans global regulatory submissions for Upadacitinib in rheumatoid arthritis in the second half of 2018.

ABBV closed Monday's trading at $90.48, up 0.78%.

Shares of Menlo Therapeutics Inc. (MNLO) cratered 76.8% on Monday, as its phase II trial of Serlopitant for the treatment of pruritus associated with atopic dermatitis did not meet its primary or key secondary efficacy endpoints.

In the trial, dubbed ATOMIK, there was no statistically significant difference between the Serlopitant treated groups and the placebo treated group in the mean change in worst-itch numeric rating scale (WI-NRS) from baseline to week 6.

The Company is planning to initiate phase III studies of Serlopitant in prurigo nodularis this quarter.

Data from phase II study of Serlopitant in refractory chronic cough are expected in the fourth quarter of this year, and that from phase II study in pruritus associated with psoriasis are anticipated by late 2018 or early 2019.

MNLO closed Monday's trading at $8.17, down 76.80%. In after-hours, the stock was up 2.20% to $8.35.

Ocular Therapeutix Inc. (OCUL) will be presenting data from its clinical and preclinical research at the combined American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators(ASCRS-ASOA) Symposium, April 13 -17.

The presentations include clinical data for lead product candidate DEXTENZA (dexamethasone insert) 0.4 mg, for the treatment of pain following ophthalmic surgery, and pre-clinical data for product candidate OTX-TIC, an intracameral injection for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension.

The New Drug Application for DEXTENZA was turned down for the second time by the FDA last July due to deficiencies in manufacturing processes and analytical testing related to manufacture of drug product for commercial production.

The Company expects to resubmit DEXTENZA NDA this quarter.

OCUL closed Monday's trading at $5.99, down 1.96%.

Tandem Diabetes Care Inc. (TNDM) has entered into a distribution agreement with Movi SpA to commercialize Tandem's t:slim X2 Insulin Pump in Italy.

Under the terms of the arrangement Movi will perform all sales, marketing and customer training and support for Tandem's products. Timing for availability of Tandem products in Italy has not yet been announced.

TNDM closed Monday's trading at $5.72, down 0.52%.

Therapix Biosciences Ltd.'s (TRPX) phase IIa study of THX-110 in adult subjects with Tourette syndrome has met its primary endpoint - resulting in an average tic reduction of 21% across the entire sample.

Tourette syndrome is a neurological disorder that is characterized by rapid, non-rhythmic stereotyped, involuntary sounds and movements called tics. Tics that produce movement are called "motor tics," while tics that produce sound are called "vocal tics" or "phonic tics."

The Company will be presenting complete results from the study at the 2018 European Society for the Study of Tourette syndrome meeting in Copenhagen, Denmark.

TRPX closed Monday's trading at $6.01, up 15.58%.

Vanda Pharmaceuticals Inc. (VNDA) is expected to post Tradipitant scientific posters at the 10th Georg Rajka International Symposium of Atopic Dermatitis on April 12, 2018.

A phase III trial of Tradipitant for atopic dermatitis is expected to begin in the first half of 2018.

VNDA closed Monday's trading at $15.40, down 5.52%.

Shares of vTv Therapeutics Inc. (VTVT) plunged more than 63% in after-hours trading on Monday, following disappointing results from Part A of its phase III program of the investigational medication Azeliragon in people with mild Alzheimer's disease.

The STEADFAST study is comprised of two independent and identical randomized, double-blind, placebo-controlled Phase 3 trials (Part A and Part B).

In the study, dubbed STEADFAST, in Part A, patients taking Azeliragon compared with placebo did not improve in cognitive or functional outcomes as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb).

The Company is discontinuing current clinical studies involving Azeliragon, including the open-label extension study and Part B of the STEADFAST study.

VTVT closed Monday's trading at $3.26, down 4.68%. In after-hours, the stock tumbled 63.80% to $1.18.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT