AKAO Faces FDA In June, TECH Opens Wallet, FPRX’s FIGHT Begins, TRVN Soars

Today’s Daily Dose brings you news about Bio-Techne’s first acquisition for the year; Tetraphase’s submission of NDA for IV Eravacycline; Five prime’s progress in phase I/III clinical trial of FPA144, and FDA’s acceptance of Trevena’s OLINVO NDA for review, to name a few.

Read on…

Achaogen Inc.’s (AKAO) second antibacterial candidate C-Scape, being developed for Multidrug resistant gram-negative infections, has found to be well tolerated across all doses in a phase I trial, with no drug-drug interaction between the previously approved compounds when dosed in combination.

C-Scape is an oral combination of ceftibuten, an approved third generation cephalosporin, and clavulanate, an approved beta-lactamase inhibitor.

C-Scape has been awarded Qualified Infectious Disease Product (QIDP) status by the FDA for the treatment of complicated urinary tract infections (cUTI), which provides incentives for new antibiotic treatments, including priority review and additional market exclusivity.

“The positive top-line results from this first-in-human clinical trial for C-Scape are supportive of further evaluation and we continue to plan for Phase 3 in 2018. FDA has previously indicated that a single Phase 3 study in cUTI, if successful, would be sufficient for licensure, and we plan to meet with the FDA in early 2018 to seek agreement on the details of our development plan,” said Kenneth Hillan, Achaogen’s President, R&D.

In other news, the Company’s New Drug Application for Plazomicin for the treatment of complicated urinary tract infections (cUTI), and bloodstream infections, has been accepted for priority review by the FDA. The regulatory agency’s decision on Plazomicin will be known by June 25, 2018.

AKAO closed Tuesday’s trading at $11.20, up 4.28%.

Avenue Therapeutics Inc. (ATXI) has dosed the first patient in its phase III safety trial of IV Tramadol for the management of moderate to moderately severe pain.

The trial is designed to enroll approximately 250 patients, who will receive 50 mg of IV Tramadol over 15 minutes at zero, two and four hours, then once every four hours thereafter. This safety study is a key component of the Company’s pivotal phase III development program of IV Tramadol.

A pivotal phase III clinical trial of intravenous (IV) Tramadol for the management of moderate to moderately severe pain in patients following bunionectomy surgery is already underway. The Company expects to report topline data from this trial in the second quarter of 2018.

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