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Going after Crohn’s and colitis
November 2016
by Jeffrey Bouley  |  Email the author
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VIENNA, Austria—Mid-October saw Boudry, Switzerland-based Celgene International Sàrl, a wholly owned subsidiary of Summit, N.J.-based Celgene Corp., announce positive data from two studies of investigational oral therapies for the treatment of Crohn’s disease (GED-0301) and ulcerative colitis (ozanimod) at the United European Gastroenterology Week in Vienna.
 
For the Crohn’s side of the equation, detailed Phase 1b results demonstrated early clinical improvement, with the highest clinical response and remission rates in the 12-week treatment group. Positive endoscopic improvement was seen across all treatment groups at 12 weeks, and safety and tolerability were consistent with previous studies.
 
According to Celgene, this matters greatly because a significant number of Crohn’s disease patients don’t reach remission with current therapies or will suffer relapses over time and are in need of new, long-term treatment options—these results reportedly demonstrate strong potential for GED-0301 to become a new oral option for patients.
 
Another important aspect of the study was that the population studied was more diverse and difficult to treat than prior GED-0301 studies and included nearly 50 percent biologic-experienced patients.
 
The rates of adverse events and serious adverse events were low and similar across treatment groups, according to the company, and there were no new safety signals for oral GED-0301 160 mg daily reported in the study.
 
“We are encouraged that oral GED-0301 showed both meaningful endoscopic improvement and clinical remission at an early time point in this study,” said Scott Smith, president of Celgene Inflammation & Immunology. “The fact that this study included nearly 50 percent biologic-experienced patients further reflects the potential of GED-0301 as a novel approach for patients with Crohn’s disease searching for alternatives.”
 
GED-0301, which is an oral antisense therapy, is an oligonucleotide designed to target the messenger RNA for Smad7, thereby reducing Smad7 protein levels. In patients with Crohn’s disease, abnormally high levels of Smad7 interfere with TGF-β1 anti-inflammatory pathways in the gut, leading to increased inflammation. GED-0301 is designed to act locally to reduce Smad7 levels with negligible systemic exposure.
 
As for the ulcerative colitis results, the open-label extension of the Phase 2 TOUCHSTONE trial of ozanimod in patients with moderate to severe ulcerative colitis showed continued symptom improvement through week 44 of the extension. Safety and tolerability were consistent with previous studies.
 
“Since ulcerative colitis is a chronic condition, patients are looking for treatments that can help them over the long term,” said Dr. William Sandborn, director of the University of California San Diego Inflammatory Bowel Disease Center. “These encouraging findings suggest that continued treatment with ozanimod shows evidence of durable efficacy with an acceptable safety profile.”
 
During the extension period, treatment with ozanimod 1 mg resulted in a decrease in mean partial Mayo Score (pMS) in all treatment arms. For patients who had been treated with ozanimod 0.5 mg during the double-blind portion of the study and were switched to ozanimod 1 mg for the extension phase of the study, mean pMS score decreased from 4.5 at entry into the extension period to 1.7 at week 44. For patients who had been initially treated with ozanimod 1 mg and stayed on ozanimod 1 mg for the extension phase of the study, mean pMS score decreased from 3.3 at entry into the extension period to 1.9 at week 44. For patients who had been initially treated with placebo and were switched to ozanimod 1 mg for the extension phase of the study, mean pMS score decreased from 4.6 at entry into the extension period to 1.7 at week 44.
 
Treatment with ozanimod 1 mg in the extension phase also showed a decrease in the proportion of patients with rectal bleeding and moderate or severe diarrhea.
 
Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1 and 5 receptor modulator in development for immune-inflammatory indications including inflammatory bowel disease and relapsing multiple sclerosis. Treatment with S1P receptor modulators is believed to work by interfering with S1P signaling and preventing a certain subtype (ccr7+) of lymphocytes (a type of white blood cell) from exiting the lymph nodes and contributing to tissue inflammation.
 
Analysts at Leerink Partners see GED-0301 as having the best potential of finding a niche market as a Crohn’s disease treatment.
 
As Leerink’s Geoffrey Porges and Bradley Canino wrote, “We have always been cautious regarding the opportunity of GED-0301 in Crohn’s disease, despite the initial impressive Phase 2 data published at the end of 2014, and these data are consistent with that view. GED-0301 appears to provide some benefit to patients, and as an oral agent with a benign safety profile (assuming confirmation with extended exposure), will likely gain some use (depending on price) as a first-line agent and an initial alternative to biologics—perhaps to be used on top of other 1L agents like the aminosalicylates.
 
“In many ways, this program parallels the development strategy for Celgene’s Otezla in psoriasis, another treatment providing modest benefit that has experienced rapid uptake due to its ease of administration (oral) and minor safety risk compared to other available treatments. However, we regard Otezla’s effect on psoriasis and psoriatic arthritis as more competitive with available alternatives than GED-0301 is in Crohn’s disease.”
 
Canaccord Genuity analyst Dr. John Newman, for his part, wrote in an investor note, “We maintain our BUY rating and $156 price target on CELG, based on our discounted cash flow valuation methodology. We view the strength of Celgene’s most recent quarterly results as a positive for the trajectory of the stock, and we will look forward to major clinical updates for ozanimod from two Phase 3 trials in 2017, as well as continued progress for GED-0301 and ongoing R squared studies for Revlimid. We also suspect CELG may reevaluate long-term guidance at JP Morgan in early 2017 based on the strength of Revlimid growth and bullish comments from management on the growth outlook ahead.”

Celgene and IBM team up to transform patient safety monitoring
 
SUMMIT, N.J. & CAMBRIDGE, Mass.—Celgene Corp. and IBM Watson Health recently announced a collaboration to co-develop IBM Watson for Patient Safety, a new offering that aims to enhance pharmacovigilance methods used to collect, assess, monitor and report adverse drug reactions. The new offering will run on the Watson Health Cloud.
 
The collaboration will combine Watson’s cognitive computing ability with Celgene’s deep history and experience in drug safety and risk management in order to create an outcome- and evidence-based drug safety decision support system for life-sciences companies. Watson’s cognitive computing engine continuously learns, so it is expected that Watson for Patient Safety will increasingly be able to help identify potential drug safety signals.
 
Watson for Patient Safety is being developed as a first-of-its-kind, highly automated drug-safety offering designed to enable the rapid collection, collation and automated analysis of high volumes of data from diverse sources, including anonymized electronic medical records, medical claims databases and other healthcare information sources. Watson for Patient Safety will be designed to drive pharmaceutical companies’ understanding of complex safety questions and delivery of evidence-based insights to help support ongoing understanding of the safety profiles of drug products by stakeholders.
 
“With this collaboration, we intend to create a paradigm shift in identifying patient safety data that we hope can be applied across the entire product lifecycle, from early development through to approved medicines,” said John Freeman, corporate vice president of global drug safety and risk management for Celgene. “The new offering we are co-developing will bring the cognitive computing power of Watson and its growing view of clinical, research and social health data to bear on this critical healthcare challenge.”
 
“Celgene established one of the first risk management systems, and its commitment to pharmacovigilance continues with this collaboration,” said Lauren O’Donnell, vice president of life sciences for IBM Watson Health. “Together we look forward to creating a cognitive solution that can be applied across the industry to help benefit patients everywhere, leveraging our cloud platform.”
 
Watson for Patient Safety will be developed in phases, with the first module anticipated within the next year.
 
Code: E111603

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