Local Tech Wire
WINSTON SALEM, N.C. – Don deBethizy, chief executive officer of drug development firm Targacept (Nasdaq: TRGT) is touting more than his company’s partnerships with drug giants GlaxoSmithKline and AstraZeneca.
Although AstraZeneca agreed to advance a drug in trials with and to make a $10 million milestone payment, deBethizy chose in a conference call with analysts to highlight internal development of a compound called TC-5214.
Using the word ‘remarkably” to describe some of trial results, deBethizy touted TC-5214 as a potential treatment for the millions of people suffering from major depressive disorder.
, deBethizy describes progress on TC-512 in this excerpt from a transcript for the Aug.5 conference call provided by SeekingAlpha. (The comments about TC-512 have been shortened slightly to meet reprint requirements.
“I will begin with TC-5214, a product candidate that is not part of our strategic relationship with AstraZeneca and GlaxoSmithKline. Last month we announced highly statistically significant top line results from a Phase 2b clinical trial of TC-5214 as an augmentation or add-on treatment in subjects with major depressive disorder, which I will refer to as MDD, who did not respond adequately to first line treatment with the anti-depressant Citalopram Hydrobromide
“With about two-thirds of an estimated 14 million American patients that still suffer with depressor symptoms, despite treatment, the unmet medical need is clear and the commercial opportunity is significant.
“Our completed Phase 2b MDD trial was conducted at 20 sites in India and three sites in the United States. The study design involves two phases. In the open label first phase, subjects with MDD received first line treatment with Citalopram for eight weeks. Subjects who qualify either as non-responders or as only partial responders continued into the double-blind placebo controlled second phase.
“These subjects received a flexible dose of either TC-5214 or placebo as add-on to continue Citalopram treatment for an additional eight weeks. The primary outcome measure from the trial was mean change from base line between the add-on 5214 group and the add-on placebo group on the 17 item Hamilton Rating Scale for Depression or HAM-D.
“Secondary efficacy outcome measures included the assessment of depression, irritability, disability, cognition, severity of illness and global improvement. As we announced in mid-July the results were highly statistically significant in favor of TC-5214, on the primary and secondary outcome measures on an intent to treat basis.
“Remarkably, the result on the primary outcome measure favored 5214 with the p value of less than 0.0001. We plan to present detailed results from the trial on October 15, 2009 at the Nicotinic Acetylcholine Receptors as Therapeutics Targets Satellite Symposium, which is scheduled to occur prior to the annual society for Neuroscience meeting in Chicago.
“Planning for further clinical development of TC-5214 is ongoing and we expect Phase 3 to be initiated in the second quarter of 2010, following end of Phase 2 discussions with the FDA and EMEA and production of clinical trial material. In parallel, we are active in discussions with multiple pharmaceutical companies with the goal of identifying a strategic partner who could help us optimize the global development and planned commercialization of our compound.”
