New MS drug Ozanimod seeks FDA approval

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New MS drug Ozanimod seeks FDA approval

Postby MSUK » Fri Nov 10, 2017 5:21 am

Drug company Celgene recently announced results from two phase III trials evaluating the efficacy and safety of the drug ozanimod and is now seeking approval from the U.S Food and Drug Administration (FDA)...Read more - http://www.ms-uk.org/new-ms-drug-ozanimod-seeks-fda-approval

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Re: New MS drug Ozanimod seeks FDA approval

Postby jimmylegs » Fri Nov 10, 2017 5:38 am

Ozanimod Successful in Clinical Trials for Multiple Sclerosis Nov 9 2017 news release
http://www.scripps.edu/news/press/2017/ ... nimod.html

TSRI and Receptos (now Celgene) Drug Poised for Further Trials Against Ulcerative Colitis, Crohn’s Disease and More

LA JOLLA, Calif. – Nov. 9, 2017 – Celgene Corporation recently announced results from two phase 3 trials evaluating the efficacy and safety of the drug ozanimod. Ozanimod was invented by scientists at The Scripps Research Institute (TSRI). Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, and was compared to the first-line treatment, Avonex® (interferon beta-1a) (IFN), in patients with relapsing multiple sclerosis (RMS). The findings from the two pivotal phase 3 (SUNBEAM and RADIANCE Part B) trials pave the way for ozanimod to enter the New Drug Approval process with the U.S. Food and Drug Administration (FDA).

RMS is the most common type of multiple sclerosis. Treating inflammation in RMS patients is key to reducing their disease relapses—or “flare ups.” Ozanimod blocks sources of inflammation in RMS by acting as a sphingosine 1-phosphate 1 (S1PR1) receptor agonist.

The RADIANCE Part B study evaluated two doses (1 mg and 0.5 mg) of oral ozanimod compared with IFN in 1,320 patients with RMS in 21 countries treated for two years. The SUNBEAM study evaluated two doses (1 mg and 0.5 mg) of oral ozanimod in 1,346 patients with RMS in 20 countries treated for at least one year.

Ozanimod demonstrated a significant reduction in new or enlarging T2 lesions over one year for 1 mg (48 percent, p < 0.0001) and 0.5 mg (25 percent, p=0.0032) compared with IFN. A significant reduction in gadolinium-enhanced MRI lesions at 1 year was also demonstrated for ozanimod 1 mg (63 percent, p < 0.0001) and ozanimod 0.5 mg (34 percent, p=0.0182) compared with IFN. Ozanimod significantly slowed the loss of brain volume compared with IFN—a hallmark of the disease that causes brain atrophy, disease progression and cognitive impairment.

“Ozanimod’s ability to inhibit brain atrophy promises patients a long and productive life, living with relapsing, remitting multiple sclerosis without disability,” said TSRI Professor of Molecular Medicine Hugh Rosen, Ph.D., M.D., co-inventor of ozanimod. “This is truly disease-modifying.”

The design and development of ozanimod stems from basic research pursued in the TSRI laboratories of Rosen, Professor Edward Roberts, Ph.D., and Professor Michael B.A. Oldstone, M.D. The TSRI scientists discovered the fundamental mechanism of the S1PR1 receptor, developed the chemical tools to synthesize both agonists and antagonists of the receptor, discovered the role of the receptor in the immune system’s “cytokine storm” in pandemic influenza, and investigated the role of the receptor in type 1 diabetes.

TSRI owns several composition-of-matter patents that cover S1P agonist compounds including key patents that cover ozanimod. TSRI licensed these patents to Receptos, which was bought by Celgene in 2015. Celgene has announced that it expects to launch the compound by the end of 2018, following FDA approval.

The new data from Celgene also make ozanimod the first compound originating from the National Institutes of Health’s (NIH) Molecular Library Initiative to successfully complete phase 3 clinical trials for safety and efficacy with data to support an FDA new drug application.

“The success of ozanimod shows that academia and the NIH can make transforming discoveries that benefit patients and those that care for them,” said Rosen.

Ozanimod is also being studied by Celgene for treating forms of inflammatory bowel disease. The drug is currently in phase 3 trials for ulcerative colitis, and Celgene recently released promising phase 2 data in a trial for Crohn’s disease. A phase 3 trial to test ozanimod in Crohn’s disease patients is expected to begin in early 2018. Celgene next plans to test potential uses for other autoimmune –based dermatological and rheumatological indications.

Celgene MS drug clears key trial, but disability data falls short May 22 2017
https://www.reuters.com/article/us-celg ... SKBN18I1E5

Celgene Corp’s multiple sclerosis drug met the main goal of reducing annualized relapse rate, compared with Biogen Inc’s Avonex, in a second late-stage trial, but failed to outperform Avonex in slowing disability progression rate.

Celgene’s shares fell as much as 2.8 percent to $113.63 in morning trading on Monday as investors focused on the disability data.

The drug, ozanimod, was shown to be superior to Avonex in reducing annualized relapse rate in patients with relapsing multiple sclerosis (RMS) in another late-stage study in February.

However, Celgene said on Monday a combined analysis of the two trials did not show ozanimod had a statistically significant benefit over Avonex in slowing disability progression.

The company highlighted that overall the rate of disability progression was very low in the trials.

Analysts did not read much into the data on disability progression, with Barclays calling it “only wrinkle” in the otherwise successful trials.

With prior results suggesting a best-in-class profile, with Gilenya-like efficacy and absent heart rate effects, ozanimod has the advantage of a shorter half-life, a favorable feature highlighted by experts in terms of safety, Wells Fargo’s Jim Birchenough said.

Gilenya is a rival MS drug from Novartis AG.

Ozanimod’s adoption will depend on whether Gilenya goes generic in 2019, which may coincide with ozanimod’s launch, Evercore ISI analyst Umer Raffat said.

Ozanimod is expected to generate about $2 billion by 2022, according to Clarivate Analytics.

Celgene, which gained access to ozanimod through its $7.2 billion acquisition of Receptos Inc in 2015, said it would file a U.S. marketing application for the drug by the end of the year.

RMS is characterized by clearly defined attacks of worsening neurologic function.

These attacks — often called relapses, flare-ups or exacerbations — are followed by partial or complete recovery periods during which symptoms improve partially or completely.

Multiple sclerosis affects about 400,000 people in the United States and about 2.5 million people worldwide. About 85 percent are diagnosed with RMS, according to the company.

The most popular MS treatment in the United States currently is Teva Pharmaceuticals Industries Ltd’s Copaxone, which generated sales of about $4.22 billion in 2016.

Celgene is also testing Ozanimod in ulcerative colitis and Crohn’s disease.

Up to Friday’s close, Celgene had gained 17 percent in the past 12 months, outperforming the 9.6 percent rise in the Nasdaq Biotechnology Index during the same period.
odd sx? no dx? check w/ dietitian
DRI=MINIMUM eg bit.ly/1vgQclQ
99% don't meet these. meds/lifestyle can affect levels
status can be low in ms & other cond'ns
'but my results are normal'. typical panels don't test all
deficits occur in 'normal' range
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