* Overall study fails to achieve statistical significance
* Says patients on 5 mg Serdaxin improved in MADRS scores
* Shares down 50 pct
(Recasts; adds company comments, updates stock movement)
By Krishnakali Sengupta
BANGALORE, April 13 Rexahn Pharmaceuticals Inc
(RNN.A) said its experimental antidepressant drug Serdaxin did
not achieve statistical significance in a mid-stage study,
sending its shares down 50 percent in afternoon trade.
The study, however, showed the drug to be safe and well
tolerated without the appearance of serious side effects that
are commonly linked to certain currently marketed drugs for the
treatment of major depressive disorder, Rexahn said in a
"This study was a proof-of-concept study from our
perspective. We were looking for a strong signal, which we did
get in the severe patient population", President Rakesh Soni
Although the overall study -- on 77 patients -- did not
achieve statistical significance, results from the subgroup
analysis showed the drug to significantly improve
Montgomery-Asberg Depression Rating (MADRS) scores in patients
treated with 5 mg of Serdaxin for 8 weeks, compared to a dummy
The MADRS rating is used to measure the severity of
depressive episodes in patients with mood disorders.
The company said it plans to start a second mid-stage
clinical trial in the second half this year and is currently in
talks with several major pharmaceutical companies to co-develop
Soni said the second mid-stage study will enroll about 400
patients and will evaluate the drug's efficacy against similar
"We are in talks with several companies, evaluating
partnerships, and we expect much higher milestone payments for
the drug than what we had with Teva," Soni added.
In 2009, Rexahn entered into an agreement with Teva
Pharmaceutical Industries (TEVA.TA) TEVA.O for the
development of one its preclinical novel anti-cancer compounds,
for which it is expected to receive a couple of hundred million
dollars in a milestone payments.
Shares of the company fell to $1.82, but recovered some of
the losses and were trading down 48 percent at $1.89 in
afternoon trade Tuesday on the American Stock Exchange.
(Reporting by Krishnakali Sengupta; Editing by Unnikrishnan