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Phase 2 ORM-12741, Orion’s Experimental Alzheimer’s Drug Shows Promise, Study Finds

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ORM-12741 in WO 2003082866
GENERAL STR
ClinicalTrials.gov Identifier:
NCT01324518

The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer’s disease.,

March 11, 2013

A small Finnish study is raising hopes for a new drug designed to help stave off memory loss among patients struggling with moderate Alzheimer’s disease.

Still in the preliminary stages of investigation, the drug — called ORM-12741 — showed promise during a three-month trial involving 100 such patients, half of whom were given the medication on top of their current drug treatment.

By the end of the study, memory scores plummeted by 33 percent among the 50 patients who were given a dummy pill (placebo) rather than the new drug, while patients who took the new drug showed a 4 percent improvement on the tests.

“The bottom line is that this was the first study investigating [effectiveness] of a drug with a novel mechanism of action in patients with Alzheimer’s disease,” said study lead author Dr. Juha Rouru, who heads the central nervous system therapy area at Orion Pharma in Turku, Finland.

“The results were clearly positive,” he said, adding they were seen particularly on important episodic memory, which involves remembering events and personal experiences. Orion, the maker of ORM-12741, funded the research.

Rouru and his colleagues are scheduled to present their work in San Diego at a meeting of the American Academy of Neurology, which starts Saturday.

By 2050, as the elderly population increases, an estimated 13.8 million Americans will have Alzheimer’s, a progressive brain disease that robs people of their memory and the ability to perform even simple everyday tasks. There is no cure for the disease, and drugs aimed at controlling the debilitating symptoms are only moderately effective, Rouru said.

With that in mind, the team set out to assess the potential of ORM-12741, the first drug to target a specific receptor in the brain, called alpha-2C. This receptor is thought to play a role in the brain’s “fight or flight” response to stress, and the authors noted that the new drug’s impact on alpha-2C had shown promise in prior animal studies.

All the patients in the study were already taking a cholinesterase drug. Some were also using memantine, another type of Alzheimer’s medication.

Fifty patients were then given a placebo on top of their current regimen, while 50 were given either a low-dose (30 to 60 milligrams) twice daily supply of ORM-12741 or a high-dose (100 to 200 milligrams) version.

Computerized memory tests highlighted an apparent memory benefit (without prompting severe side effects) among the ORM-12741 patients, and Rouru suggested that the new drug should be seen as just one more potentially effective tool in an ongoing battle to reign in “a devastating disease.”

“I am afraid that wonder drugs hardly exist,” he noted. “In the present study, our drug was used on top of existing Alzheimer’s medications. In that setting it showed clear effect, which suggests that it is giving additional clinically significant benefit for patients that are already using Alzheimer’s medications.”

Catherine Roe, an assistant professor of neurology at Washington University School of Medicine in St. Louis, described Rouru’s research as “impressive.”

“This is really a new approach, in terms of the biology that they’re targeting,” she noted. “And they showed significant results after only three months of treatment, which is exciting particularly because this drug combination was tested on people who had moderate Alzheimer’s disease.”

Many experts have thought moderate Alzheimer’s disease would be untreatable, she said. “By the time it’s that advanced, the nerves have already died and it would be too late to do anything about memory by this stage,” she explained.

Still, much more testing will need to be done, Roe cautioned. “And these results will have to be replicated with other groups of people,” she said. “But if they can do that, this would be awesome.”

The data and conclusions of research presented at medical meetings are typically considered preliminary until published in a peer-reviewed journal.

More information

For more on Alzheimer’s disease, visit the U.S. National Institutes of Health.

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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