Q3 2019 Earnings Call
Welcome to the Minerva Neurosciences third quarter 2019 conference call at this time all participants.
We know there will be a question and answer session. Following today's prepared remarks.
I was being webcast live on the Investor section of the nervous website at <unk> Dot Minerva Neurosciences Dot com.
Sure Minder today's call is being recorded I would now like to turn the call over to William Boni, Vice President Investor Relations and corporate Communications Minerva. Please proceed.
Good morning.
Press release with the Companys third quarter 2019 financial results became available at 730, <unk> Eastern time today and can be found on the investor section of our website.
Quarterly report on Form 10-Q was also filed electronically with yes, we see this morning and can be found on the Fccs website at Www Dot Si Si dot Gov.
Joining me on the call today from Minerva are Dr. Reddy move trigger executive Chairman and Chief Executive Officer, Mr., Jeff race, Executive Vice President Chief Financial Officer, and Chief Business Officer, and Mr., Rick Russell Preston.
Following our prepared remarks, we will open the call for Q1 day.
Before we begin I would like to remind you that today's discussion will include statements about the company's future expectations plans and prospects that constitute forward looking statements for purpose. We took the safe Harbor provisions under the private Securities Litigation Reform Act of 1995.
We cautioned that these forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicators.
These forward looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors that are more fully detailed under the caption risk factors in our filings with the FCC, including our quarterly report on Form 10-Q for the quarter.
<unk> ended September Thirtyth 2019 filed with the U.S., we see on November four 2019.
Any forward looking statements made on this call speak only as of today's date Monday November four 2019.
The company disclaims any obligation to update any of these forward looking statements to reflect events or circumstances that occur after today's call except as required by law.
I would now like to turn the call over to Remy Luthringer.
Thank you Bill and the good morning, everyone. Thanks for joining us today.
As we near the end of this year.
I'd like to reviews. The progress we have made during 2019 in each of our clinical stage programs.
First.
We have completed and Red dog topline results from four trials, we have direction. It major depressive disorder, M.D.D. and insomnia second we have concluded enrollment in a phase to be trial was made 117, M.D.D. and we expect to have topline results into fourth quarter of 2019 finally, we have advance.
Patient enrollment private for phase three trial, we all believe product for the paradigm.
We have resumed the pacing patient recruitment followings, a temporary delay we discussed in October .
Beginning with the phase three trial before the parador enrollment rates have returned to expected level.
As we stated last month, we remain on track to complete enrollment the 501 patients at the approximate the door and.
You know assessing the impact of the recent pools in recruitment. So if we discussed in October we come to the expanding the number of trial sites to compensate for slower enrolled pets, we chose to not jeopardize the integrity of the study and elected to maintain quality over speed.
He's randomized double blind Polyvore placebo controlled trial is designed to otherwise you efficacy and safety or sort you told me the grams, and 64 milligrams or probably paradigm as monotherapy in other patients suffering from negative symptoms of schizophrenia.
The primary endpoint of these trials the change from baseline negative symptoms using as a positive and negative sintrom scale palms modest negative symptoms like the score and if that's what was a 12 week double blind treatment period.
After 12 weeks patients entry into a 14 week open label extension period during which shows on active drug hearings a double blind phase continues to receives unfortunately those.
Why patients on placebo, a randomized to receive Asia. So if he told me they grow or 64 Big one we'll talk to drug.
The last two answers extension period.
Key secondary endpoints includes a personal and social performance Crane, PSP and clinical global impression of severities C.G. I guess.
He's tried is addressing a significant unmet medical need negative symptoms in schizophrenia.
Which no treatments are approved.
Our overriding objective you still maintains a quality of patient screening and selection to ensure support enrolled patients treats the me.
These pre defined entry for Terry.
Other activities related to the rotary Paragon program, specifically preparation for the fighting well for new drug application remain on track.
For example, during the past quarter, we entered into a commercial supply agreement with caterpillar and the which we will transition from pilot to commercial scale manufacturing and packaging. We remain confident it's a potential just tried to generate the product.