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Derica W. Rice, EVP, Global Services, and CFO, gave guidance for data from the phase II/III trial of mGlu2/3 for schizophrenia. He stated, "We do not have with us the specific timing for the trial. The one thing I would highlight is, Ronika had mentioned the presentation earlier this year of the 6 month safety data. We'll have maybe late this year at the best or early next year the opportunity to present the 12 month safety data from that trial. So, that is going to be the next major data read-out that I would point you to for mGlu2/3."
Source: Q1 2011 earnings conference call, 4/18/11.

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Ronika Pletcher, Director Investor relations, gave guidance for six month data from the ongoing study of mGlu 2/3 for schizophrenia. She stated, "But you might remember back in 2009, we started a safety and tolerability study for mGlu 2/3. It started out as a six-month study and in that study, our intent was to get a better understanding on some of the earlier observations on the mGlu trials. That study, we now have six-month data on that study, which we plan to actually disclose at a European event in April. That study actually did have two additional seizures in that study. Of those two, one of the patients had the seizure actually before they were randomized to drug and the second patient actually had their seizure after they came off of study drug and before initiating the typical. So we are now getting that additional information to help us understand but we feel confident in the data that we have so far on that six-month study to now go ahead and move ahead with our phase III program and that's also in combination with our prior phase II, or phase II studies that were presented and published back in 2007 and 2009."
Source: Q4 2010 earnings conference call, 1/27/11.

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A Long-Term, Open-Label, Multicenter Study of LY2140023 Compared to Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia
Estimated Enrollment: 1210
Study Start Date: June 2010
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01129674?term=mGlu&rank=2

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Pomaglumetad Methionil (mGlu2/3) (LY2140023)PsychiatrySchizophreniaGlutamate agonistMetabotropic glutamate 2/3 (mGlu2/3) receptor

Mechanism of action: Pomaglumetad Methionil (mGlu2/3) (LY2140023) is a selective agonist for metabotropic glutamate 2/3 (mGlu2/3) receptors. Agonists for mGlu2/3 receptors decrease the evoked release of glutamate at certain (ie. forebrain / limbic) glutamatergic synapses, indicating that the functional role of mGlu2 and/or mGlu3 receptors is to suppress glutamate excitations. This offers a mechanism for dampening glutamate excitation under pathological states resulting from excessive glutamate release. Glutamatergic dysfunction has been implicated in psychotic states and possibly in the etiology of schizophrenia.

Phase of Development: II/III

Event Type: Data: Phase II/III trial results

Dates: 2011-12-01 - 2012-02-29

Results:

Lilly Stops Phase III Development of Pomaglumetad Methionil For the Treatment of Schizophrenia Based on Efficacy Results

INDIANAPOLIS, Aug. 29, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today the decision to stop ongoing clinical studies investigating pomaglumetad methionil, also known as mGlu2/3, for the treatment of patients suffering from schizophrenia. The decision was made after a recently conducted independent futility analysis concluded HBBN, the second of Lilly's two pivotal studies, was unlikely to be positive in its primary efficacy endpoint if enrolled to completion. The decision was not based on any safety signals.

Additionally, the recently completed Phase II study, HBCO, which investigated pomaglumetad methionil as an adjunctive treatment with atypical antipsychotics, did not meet its primary endpoint.

Lilly is contacting study investigators to outline specific actions related to the close-out of each ongoing study. Lilly will work with study investigators to ensure an appropriate transition of study participants to continuing clinical care outside of the trials.

"I'm disappointed in what these results mean for patients with schizophrenia who still are searching for options to treat this terrible illness," said Jan Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories. "While there are many challenges in this complex field of research, neuroscience remains a core area of focus at Lilly. Our clinical development pipeline includes nearly a dozen neuroscience molecules being studied to treat illnesses such as depression, bipolar disorder and cognitive impairment associated with schizophrenia."

The decision to stop ongoing Phase III development of pomaglumetad methionil is expected to result in a third-quarter charge to R&D expense in the range of $25 million to $30 million (pre-tax), or approximately $0.02 per share (after-tax). The company's previously-issued financial guidance for 2012 remains unchanged.
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Source: press release, 8/29/12. https://investor.lilly.com/releaseDetail.cfm?ReleaseID=703018

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Lilly Announces Pomaglumetad Methionil Did Not Meet Primary Endpoint of Clinical Study
Development of the molecule continues based on observed safety profile, additional data anticipated later in 2012

INDIANAPOLIS, July 11, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today negative clinical trial results from study H8Y-MC-HBBM (HBBM) investigating pomaglumetad methionil, also known as mGlu2/3, for the treatment of patients suffering an acute exacerbation of schizophrenia. In study HBBM, pomaglumetad methionil did not separate from placebo in the primary efficacy endpoint in either the overall or predefined genetic subpopulation (based on the Positive and Negative Syndrome Scale, PANSS) at the two doses investigated (40 mg and 80 mg BID). The active control, risperidone, did separate from placebo in both populations. Pomaglumetad methionil was generally well tolerated in this study, with no new safety findings compared to previous trials. Data will be shared at a later date at an appropriate scientific venue.

HBBM was intended to be the first of two clinical trials to support registration of the compound for monotherapy in acute schizophrenia. The second registration clinical trial, H8Y-MC-HBBN (HBBN), is ongoing. The company will conduct an interim analysis of study HBBN which will provide results later in the year. Additionally, Lilly awaits results from the recently concluded study H8Y-MC-HBCO (HBCO). HBCO is a Phase II study exploring pomaglumetad methionil as an adjunctive treatment with atypical antipsychotics. Data from these two studies will help inform decisions on the future development of pomaglumetad methionil. Ongoing clinical trials with pomaglumetad methionil continue.

"Unfortunately negative studies are common in the field of psychiatry and a reality of biopharmaceutical innovation," said Jan Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories. "Despite all of the advances, the need for new and better treatments for those suffering with mental illnesses is among the most urgent in medicine. Lilly has long been a pioneer in neuroscience, and we're committed to discovering and delivering breakthrough treatments that make a difference for patients. Right now, we're developing more than a half dozen potential new medicines to treat neuroscience-related diseases and disorders, including among others, depression, Alzheimers disease and schizophrenia."
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Source: press release, 7/11/12. https://investor.lilly.com/releaseDetail.cfm?ReleaseID=690836