CLSD Progressing With TYBEE, SNY In Legal Spat With MYL, TBPH On Watch

(RTTNews) - Today's Daily Dose brings you news about Clearside's progress in its diabetic macular edema study; Gilead's promising data from its phase II trial of GS-0976 in patients with nonalcoholic steatohepatitis; Sanofi's legal spat with Mylan, and Theravance's near-term catalyst.

Read on...

Clearside Biomedical Inc. (CLSD) has completed patient enrollment in its phase II trial of CLS-TA, for suprachoroidal administration, used together with intravitreally administered EYLEA for the treatment of diabetic macular edema.

In the phase II trial, dubbed TYBEE, suprachoroidal CLS-TA along with intravitreal Eylea is compared to intravitreal Eylea monotherapy, in patients with diabetic macular edema who are naïve to pharmacologic treatment. Patient follow-up in the TYBEE trial is 6 months.

The primary outcome measure is a comparison of mean change from baseline in best corrected visual acuity between the two study arms. An additional analysis will be a comparison between the number of injections required between the two groups.

The Company expects to report three-month preliminary data from the TYBEE trial in the first half of 2018.

CLSD closed Tuesday's trading at $7.71, down 3.62%.

Gilead Sciences Inc. (GILD) has announced promising data from its phase II trial evaluating two doses of GS-0976 in patients with nonalcoholic steatohepatitis (NASH). The study included 126 patients who were randomized to receive GS-0976 20 mg, GS-0976 5 mg or placebo once daily for 12 weeks.

The data demonstrate that the higher dose of GS-0976 (20 mg taken orally once daily) when administered for 12 weeks was associated with statistically significant reductions in hepatic steatosis (buildup of fat in the liver) and a noninvasive marker of fibrosis (TIMP-1) compared to placebo.

GILD closed Tuesday's trading at $80.10, down 0.09%.

Sienna Biopharmaceuticals Inc. (SNNA) has dosed the first patient in its phase 2b clinical trial of topical product candidate SNA-120 (pegcantratinib) in the treatment of pruritus, or itch, associated with psoriasis and in the treatment of psoriasis itself.

The trial will evaluate the efficacy, safety and tolerability of SNA-120 compared to vehicle in approximately 190 patients with at least moderate pruritus and mild-to-moderate psoriasis.

The top-line results from this trial are expected in the first half of 2019.

SNNA closed Tuesday's trading at $20.66, down 2.96%.

Sanofi (SNY) has filed a patent infringement suit against Mylan N.V., (MYL) alleging infringement of 18 patents covering its top-selling Lantus (insulin glargine injection, 100 Units/mL) and Lantus SoloStar products.

Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar. Lantus SoloSTAR is a prefilled pen for injection of insulin.

In mid-September, Mylan had filed a NDA (505(b)(2) New Drug Application with the FDA for insulin glargine pre-filled pen and vial drug products. Mylan had also challenged all of the patents covering Sanofi's Lantus and Lantus SoloStar products.

SNY closed Tuesday's trading at $49.01, down 1.23%.

Theravance Biopharma Inc. (TBPH) will be reporting new results from two previously completed pivotal phase III studies of Revefenacin in patients with moderate to very severe chronic obstructive pulmonary disease at the 2017 CHEST annual meeting, being held in Toronto, Ontario on October 28 - November 1, 2017.

The Company plans to submit a new drug application for Revefenacin to the FDA this quarter.

TBPH closed Tuesday's trading at $31.20, down 2.83%.