July 14 (Reuters) - Targacept Inc said it was ending a mid-stage trial on its Alzheimer's drug as it did not show superiority over standard medication, sending its shares down as much as 19.8 percent.
The drug, TC-1734, which was being tested against Pfizer Inc's donepezil, had earlier failed another mid-stage trial conducted by partner AstraZeneca Plc.
"Based on (today's) results, we do not intend to invest in further development of TC-1734," Targacept Chief Executive Stephen Hill said.
UK-based AstraZeneca returned rights to the drug in March but the companies continue to co-develop another Alzheimer's drug, AZD1446.
The latest failure marks another setback to Targacept's already thinning pipeline. In September, the company discontinued the development of its schizophrenia drug, TC-5619 after it failed a mid-stage study.
(Reporting By Amrutha Penumudi; Editing by Don Sebastian)
RIGL - Another candidate loaded with cash, but weighed down with a string of clinical failures, which could give RCPI what they need. Rigel Pharmaceuticals has over $170M in cash, and is reeling from a drug setback in dry eye disease ("The drug is aimed at reducing the underlying inflammation responsible for the symptoms of chronic dry eye syndrome"):
Reuters Aug 13 (Reuters) - Rigel Pharmaceuticals Inc said it would stop testing its drug for some patients with dry eye disease after the treatment failed a mid-stage study.
The study was evaluating the eye drop formulation of the drug, R348, against a placebo. The drug is aimed at reducing the underlying inflammation responsible for the symptoms of chronic dry eye syndrome.
R348's failure is the latest in a string of setbacks for Rigel. The company stopped developing its skin disorder and asthma drugs last year after the treatments failed mid-stage trials.
British drugmaker AstraZeneca Plc scrapped its licensing deal for Rigel's rheumatoid arthritis treatment in June 2013.
The only other drug left in Rigel's armory, fostamatinib, is being tested for use in Immune Thrombocytopenic Purpura, a blood disorder, and IgA Nephropathy, a chronic autoimmune disease.
Rigel said it planned to continue another mid-stage study of R348 in dry eye patients with graft versus host disease.
There "may be more scientific rationale" in developing the compound in this indication, Wells Fargo analyst Brian Abrahams said.
Chronic dry eye syndrome affects the eye's tear-producing glands. Patients suffer from blurred vision and also experience itching or a burning sensation in the eyes.
The disease affects more than 5 million Americans and many patients with chronic dry eye syndrome also suffer from autoimmune conditions, the company said.
Rigel also said it would stop testing another drug, codenamed R118, due to its side-effect profile in early-stage trials.
The San Francisco, California-based company's stock was down 10.5 pct at $2.77 on the Nasdaq on Tuesday. The stock recorded its biggest intra-day percentage fall in about a year.
(Reporting by Natalie Grover in Bangalore; Editing by Simon Jennings)
TRGT-The hits keep coming at 'em. Still have over $100m in cash though. The two companies should talk: Mullan/RCPI really needs capital, and TRGT needs a drug...badly:
Targacept Announces Negative Top-Line Results from Exploratory Study of TC-6499 in Diabetic Gastroparesis
WINSTON-SALEM, NC--(BUSINESS WIRE)--
Targacept, Inc. (TRGT) today announced top-line results from a Phase 1/2 exploratory study of TC-6499 as a treatment for diabetic gastroparesis, a chronic disorder that slows or stops the passage of food from the stomach to the small intestine. In the trial, TC-6499 did not meet the primary endpoint of the study, change in gastric emptying half-time (BT_t1/2), as measured by a carbon (13C) labeled gastric emptying breath test, relative to placebo.
“The results we saw do not support the prior signal we had seen suggesting that TC-6499 might increase gastric motility in this patient population,” said Dr. Stephen A. Hill, Targacept’s President and Chief Executive Officer. “While TC-6499 did demonstrate a positive safety and tolerability profile in this study, these results do not warrant further development of TC-6499 in this therapeutic area.”
About the Study
The Phase 1/2 exploratory study was a double-blind, placebo-controlled, randomized, four-way crossover study conducted at seven sites in the United States. A total of 21 subjects with diabetic gastroparesis completed the study and received one of four treatments (2mg, 5mg and 10mg of TC-6499 and placebo) in a randomized, crossover manner on each of four treatment visits, with each dosing period separated by approximately seven days. The primary endpoint of the study was change in gastric emptying half-time (BT_t1/2), as measured by a carbon (13C) labeled gastric emptying breath test, for each active treatment relative to placebo. The study also assessed the safety, tolerability and pharmacokinetics of TC-6499.
Targacept has historically focused on developing NNR Therapeutics™ to treat patients suffering from serious nervous system and gastrointestinal/genitourinary diseases and disorders. Targacept is dedicated to building health and restoring independence for patients. For more information, please visit www.targacept.com.
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