CAH Closer To FDA Approval, Another Alzheimer's Disease Drug Fails, VTVT Tanks

(RTTNews) - Today's Daily Dose brings you news about expanded FDA approval for Agilent's Dako PD-L1 IHC 22C3 pharmDx assay; Albireo Pharma's lead product candidate A4250 securing rare pediatric disease designation from the FDA for the treatment of progressive familial intrahepatic cholestasis; Cardinal Health's INCRAFTAAA Stent Graft System getting favorable FDA panel recommendation; Lilly and AstraZeneca pulling the plug on Alzheimer's disease drug candidate; dermatomyositis study results of Idera and disappointing Alzheimer's disease study results of vTv Therapeutics.

Read on…

Agilent Technologies Inc.'s (A) Dako PD-L1 IHC 22C3 pharmDx assay has been approved for expanded use to be used as an aid to identify cervical cancer patients who are most likely to benefit from treatment with Merck's KEYTRUDA.

The laboratory test Dako PD-L1 IHC 22C3 pharmDx assay is already approved to help doctors identify gastric cancer patients who are eligible for treatment with KEYTRUDA.

A closed Tuesday's trading at $66.32, up 0.29%.

Albireo Pharma Inc.'s (ALBO) lead product candidate A4250 has been granted rare pediatric disease designation by the FDA for the treatment of progressive familial intrahepatic cholestasis (PFIC), a rare and life-threatening liver disease with no approved pharmacologic treatment option.

There are currently no approved pharmacological treatment options for PFIC.

A phase III clinical trial designed to evaluate A4250 in 60 patients aged 6 months to 18 years with PFIC (subtype 1 or 2) who have elevated serum bile acid (sBA) levels and pruritus, is underway.

ALBO closed Tuesday's trading at $32.00, down 1.87%.

Cardinal Health's (CAH) INCRAFTAAA Stent Graft System for the treatment of infrarenal abdominal aortic aneurysms (AAAs), a severe and complex condition, is one step closer to the market, with an FDA panel, voting 11 to 4, recommending its approval.

An abdominal aortic aneurysm is a bulging, weakened area in the wall of the lower part of the aorta, the main artery of the body, which, unless treated, can rupture and lead to a life-threatening hemorrhage. An estimated 1.5 million people in the United States have AAA, and more than 200,000 new diagnoses are made each year, noted the Company.

The INCRAFT system received a CE mark in 2014, and is commercially available in 39 countries.

CAH closed Tuesday's trading at $53.55, down 0.48%. In after-hours, the stock was up 2.24% to $54.75.

Eli Lilly and Company (LLY) and AstraZeneca (AZN) have pulled the plug on their phase III clinical trials of Lanabecestat, dubbed AMARANTH and DAYBREAK-ALZ, for the treatment of Alzheimer's disease.

The decision is based on recommendations by an independent data monitoring committee (IDMC) which concluded that both the AMARANTH trial, in early Alzheimer's disease, and the DAYBREAK-ALZ trial, in mild Alzheimer's disease dementia, were not likely to meet their primary endpoints upon completion and therefore should be stopped for futility. As a result of this decision, the related AMARANTH extension trial will also be discontinued.

The development of Alzheimer's drugs has been marred by a high failure rate. A U.S. study, which analyzed how the Alzheimer's clinical trials fared during the period of 2002 to 2012, revealed a failure rate of 99.6% compared to a failure rate of 81% for cancer drugs.

LLY closed Tuesday's trading at $85.49, down 0.43%.

Related Reading:

Race For A New Alzheimer's Drug

Galectin Therapeutics Inc. (GALT) has named Harold Shlevin, its current Chief Operating Officer (COO), to the post of Chief Executive Officer and President.

Harold Shlevin succeeds Peter Traber, who has tendered his resignation as President, CEO and Chief Medical Officer. The transition will be effective July 6, 2018.

Last month, the Company announced that it is proceeding with plans for a phase III trial program with its galectin-3 inhibitor GR-MD-02 in NASH cirrhosis.

GALT closed Tuesday's trading at $6.33, up 5.85%.

Idera Pharmaceuticals Inc.'s (IDRA) phase II clinical trial of IMO-8400 in adult patients with dermatomyositis has failed to meet its primary endpoint.

The primary objective of the trial was to assess the change from baseline in the Cutaneous Dermatomyositis Disease Area and Severity Index ("CDASI") activity score, an outcome measure of skin disease severity, versus placebo.

IDRA closed Tuesday's trading at $1.76, down 8.81%.

Shares of vTv Therapeutics Inc. (VTVT) tanked more than 27% in after-hours on Tuesday, following disappointing news about its Alzheimer's clinical trial, dubbed STEADFAST Study.

The STEADFAST is a phase III trial evaluating Azeliragon in patients with mild Alzheimer's disease. The STEADFAST trial has 2 parts - Part A and Part B. Part A enrolled patients in the United States and Canada. Part B included study sites in the United Kingdom, Ireland, Australia, New Zealand and South Africa.

The Company announced disappointing results from Part A of its STEADFAST study on April 9, 2018, which sent the stock plunging more than 63%.

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 Part B of STEADFAST Study, the results of which were announced yesterday, also did not meet co-primary efficacy endpoints of improvement in cognitive or functional outcomes as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) at 12-months compared to placebo.

Be that as it may, the Company said it will pursue expedited discussions with the FDA to propose a pathway for further clinical development in support of regulatory approval of Azeliragon.

VTVT closed Tuesday's trading at $1.89, up 4.42%. In after-hours, the stock was down 27.51% at $1.37.