BI-1181181

June 29, 2015 By Alex Keown , BioSpace.com Breaking News Staff FORT WASHINGTON, Pa. – A diabetes drug being developed by Vitae Pharmaceuticals, Inc. failed to reduce blood sugar levels in patients in a mid-stage clinical trial, the company announced this morning. The company’s stock fell nearly 13 percent in response to the news. The stock was trading at $13.09 this morning, down from $14.18 per share. The experimental drug, VTP-34072, being co-developed by Boehringer Ingelheim , was being tested as an add-on to metformin, a common diabetes therapy, to treat type 2 diabetes in overweight patients. VTP-34072 is being studied for the treatment of type 2 diabetes and metabolic syndrome, and is Vitae ’s most advanced product candidate. The drug was being tested over a 28 day period, but it failed to meet the endpoints of the trial. Additional data from the placebo-controlled monotherapy arm of the trial, which is ongoing, are expected to be reported later this year. Richard Gregg , the chief scientific officer of Vitae , said he was anxious to learn more about the company’s lead product after all the data had been analyzed. “The metabolically complex, overweight type 2 diabetic patient population is in need of novel mechanisms of action that can address their overall risk profile,” Gregg said in a statement. In earlier clinical trials VTP-34072 was shown to have had a positive impact on multiple cardiovascular and metabolic risk factors associated with metabolic syndrome. When all data is available Boehringer Ingelheim will determine the next steps for the experimental drug, the company said this morning in a statement. However, some analysts predict there will not be further studies of the drug. Wedbush analyst Liana Moussatos told Reuters she did not expect the drug to continue being tested unless the monotherapy trial had “spectacular results”. There were approximately 30 million people in the United States diagnosed with Type2 diabetes in 2015, according to the American Diabetes Association . It is expected up to 9 million more Americans are undiagnosed. If the present trends continue, as many as one in three American adults are expected to have type 2 diabetes by 2050. More than 200,000 people die each year from diabetic complications, according to data compiled by the association. Patients with metabolic syndrome, which affects approximately 85 percent of patients with type 2 diabetes, are characterized by being overweight and having elevated glucose, blood pressure, cholesterol and triglycerides, while having decreased levels of HDL-C or “good cholesterol.” The economic cost of diagnosed type 2 diabetes in the United States was estimated to be $245 billion in 2012 and, of that, approximately $9.6 billion was spent on type 2 diabetes drugs, including DiaBeta, Glynase, Glucotrol and Amaryl. The failure of VTP-34072 comes only a few months after Vitae had to put its Alzheimer’s disease treatment on hold for safety evaluations. That drug, BI 1181181 , was also being co-developed by Boehringer Ingelheim . The drug was put on hold after patients in an early clinical trial reported skin reactions to the drug. As Rumors Swirl About GlaxoSmithKline Bid, Who Could Suitors Be? Rumors are swirling that Swiss-based Roche and U.S.-based Johnson & Johnson are eying the U.K. company for approximately $143 billion. But Roche and J&J aren’t the only companies though who have been thought could go after the elephant that is Glaxo. Last month there was buzz that Pfizer Inc. was considering acquiring Glaxo , a year after it failed to acquire AstraZeneca PLC . Just this month over a third of respondents in a poll conducted by BioSpace believe that AstraZeneca PLC could be in the running to acquire struggling GlaxoSmithKline (GSK) . So BioSpace wants to ask our readers again what they predict for this new dealmaking bonanza. Will Glaxo go—and if so, to whom? var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "as-rumors-swirl-about-glaxo-bid-who-could-suitors-be", placeholder: "pd_1434950261" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed'));

February 27, 2015 By Krystle Vermes , BioSpace.com Breaking News Staff Clinical stage biotechnology company Vitae Pharmaceuticals, Inc. , announced on Feb. 26 that its partner, Boehringer Ingelheim , has placed experimental Alzheimer’s drug 1181181on hold after trial subjects experienced skin-related side effects. The beta secretase inhibitor was being evaluated in Phase I clinical trials for the treatment and prevention of Alzheimer’s disease. During testing, researchers found noticeable skin reactions in study participants. This came after a multiple rising dose trial. “Our partner is working diligently to evaluate and understand this observation,” said Richard Gregg , chief scientific officer of Vitae . “We are confident that the analysis will result in a clear understanding of how to proceed with BI 1181181, and we remain committed to our partner and the BACE program.” BI 1181181 is the only orally active BACE inhibitor from Vitae Pharmaceuticals . Boehringer Ingelheim is assisting with its development under a research collaboration and license agreement. “Depending on the outcome of the evaluation and Boehringer Ingelheim ‘s decision, we expect that either BI 1181181 or its structurally distinct, Phase 1-ready back up will be advanced, with the goal of delivering a medicine with disease-modifying benefits to patients suffering from Alzheimer’s disease,” Gregg continued. Vitae ’s portfolio consists of products that have been generated by Contour, its proprietary structure-based drug discovery platform. An In-Depth Look at Contour Contour is focused on structure-based drug design by building a drug-like molecule in the active site of a protein target one fragment at a time. Then it attempts to predict how tightly the molecule will bind to a protein. Currently, a team of scientists from Vitae Pharmaceuticals is using Contour to create innovative drugs for Alzheimer’s disease, autoimmune disorders, atopic dermatitis, and acute coronary syndrome. Vitae Pharmaceuticals has the worldwide commercial rights to three of its drugs in its pipeline – VTP-43742, VTP-38543, and VTP-38443. These products address autoimmune diseases, atopic dermatitis and acute coronary syndrome, and they are each in the preclinical phase. Boehringer Ingelheim has the worldwide commercial rights to two of the company’s pipeline products that have made it to Phase I clinical testing – VTP-34072 and VTP-37948. VTP-34072 is a HSD1 inhibitor that targets type 2 diabetes, and VTP-37948 is the BACE inhibitor that focuses on Alzheimer’s disease. VTP-43742 is a RORyt inhibitor that is expected to begin Phase I clinical trials in the first half of 2015 as a treatment for psoriasis and multiple sclerosis. BioSpace Temperature Poll Analyst Mark Schoenebaum , a biotech and pharmaceuticals analyst and medical doctor for ISI Group Evercore , has been running a Best Hair in Biopharma contest for several months now. So far, the candidates are Bristol-Myers Squibb Company ‘s John Elicker , Receptos ’ Chief Executive Officer Faheem Hasnain , Celgene ‘s Vice President of Investor Relations Patrick Flanigan and Acorda Therapeutics ’ Ron Cohen . We want to know what our BioSpace community thinks: Who do you believe actually has the Best Hair in BioPharma? var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "will-hiring-heat-up-in-2018", placeholder: "pd_1424676772" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed')); Read at BioSpace.com