Omeros Finalizes Clinical Plan For Kidney Disease Treatment, Reports Additional Positive Phase 2 Data

Omeros Corporation
OMER 3.71%
shares are seeing buying interest Thursday following a clinical update on its lead human monoclonal antibody OMS721, which is being evaluated for IgA nephropathy.

What Happened
IgA nephropathy is a kidney disease resulting from the accumulation of an antibody called immunoglobin A in the kidney, which causes inflammation and in turn impacts the ability of the kidney to filter wastes from blood.

Following a meeting with the FDA on the Phase 3 trial, Omeros said Thursday it has finalized its clinical plan for OMS721.

OMS721 targets MASP-2, the effector enzyme of the lectin pathway of the complement system. The company said the FDA agreed to extend the primary endpoint of the assessment of proteinuria from 24 weeks to 36 weeks to allow additional dosing if warranted. This allows a path to accelerated or full approval, either in the entire population or the high-risk population, according to Omeros.

The FDA also agreed for allowing open-label treatment of the high-risk population only after at least one year of blinded treatment. The change in the trial design is viewed negatively by a few, including Stat biotech reporter Adam Feuerstein.

Omeros said the Phase 3 ARTEMIS-IGAN study for which enrollment is underway will incorporate the beneficial changes agreed to with the FDA without impacting the study patients already enrolled.

The biotech announced additional data from patients in the second cohort of the Phase 2 trial, which showed stable eGFR measurements and 61-percent median reduction in proteinuria from baseline. Five of the eight patients achieved greater than 50-percent proteinuria reductions, and across the first and second cohorts, nine of the 12 patients achieved greater than 50-percent reductions in proteinuria, the company said.

Why It’s Important
IgA nephropathy has no approved therapy. Omeros is also evaluating the asset for other kidney ailments such as stem-cell transplant associated TMA, atypical hemolytic uremic syndrome, lupus nephritis and other renal diseases.

“The data, together with the recently finalized registration plan, are further consistent with our expectations that the OMS721 Phase 3 ARTEMIS-IGAN trial will be successful, and we look forward to making the drug available to our patients,” Richard Lafayette, chair of the OMS721 IgAN Academic Leadership Committee, said in a statement.

What’s Next
“We’re confident in the effects seen with OMS721 and in our registration approach for the drug in IgA nephropathy, and we expect that it will likely follow stem-cell transplant TMA as the second approved indication for OMS721,” Omeros CEO Gregory Demopulos said in a statement.

Omeros shares were trading up by 1.35 percent at $13.10 at the time of publication Thursday.


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Serious kidney injury common during cancer chemotherapy

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Nearly one in 10 cancer patients treated with chemotherapy or newer targeted drugs may be hospitalized for serious kidney injury, a Canadian study suggests.

The study involved roughly 163,000 patients who started chemotherapy or targeted therapies for a new cancer diagnosis in Ontario from 2007 to 2014. Overall, 10,880 were hospitalized with serious kidney damage or for dialysis.

This translated into a cumulative acute kidney injury rate of 9.3 percent, the study found.

People with advanced tumors were 41 percent more likely to have acute kidney injuries than patients with early-stage cancer.

Compared to the group as a whole, individuals who already had chronic kidney disease were 80 percent more likely to be hospitalized for a kidney injury, and people with diabetes had a 43 percent greater chance.

“Patients should be aware that kidney injury can result during cancer treatment – both due to cancer itself and the drugs used to treat it,” said lead study author Dr. Abhijat Kitchlu of the University of Toronto.

Many medicines that treat tumors are removed from the body by the kidneys and can damage certain cells within the kidneys, Kitchlu said by email.

“It may be possible to reduce the risk of acute kidney injury by maintaining good hydration and in some cases, avoiding other drugs that can increase risk to the kidneys,” Kitchlu added. Medications that can damage the kidneys include ibuprofen and other non-steroidal anti-inflammatory drugs(NSAIDs), certain blood pressure medicines, and diuretics. In fact, in the study, older patients taking water pills or certain heart medications were also at higher risk for serious kidney problems.

“Patients should seek early medical attention when concerned about dehydration or infection, as the symptoms related to kidney injury (decreased urine output, swelling, nausea, fatigue or confusion) may only occur after the kidneys have been damaged,” Kitchlu advised.

In the current study, patients were more than twice as likely to develop acute kidney problems within the first 90 days of starting cancer treatment than they were later on, researchers report in the Journal of the National Cancer Institute.

Patients who are already at high risk of kidney damage because of health problems like diabetes may be able to take cancer drugs that are less likely to damage the kidneys, said Leah Siskind, of the University of Louisville Medical School in Kentucky.

“However, these less nephrotoxic chemotherapeutics are often less effective at reducing tumor burden,” Siskind, who wasn’t involved in the study, said by email.

Patients at high risk for kidney damage should discuss alternative drugs or doses with their physicians to see if they can treat tumors in a way that minimizes their chance of kidney injury, advised Dr. Laura Cosmai of San Carlo Borromeo Hospital in Milan, Italy.

And all patients should be on the alert for potential warning signs of kidney problems like dehydration, nausea, vomiting or diarrhea, Cosmai, who wasn’t involved in the study, said by email.

Vigilance is important because “cancer patients who develop acute kidney injury during treatment do have reduced survival odds,” Cosmai said.

Kidney Flown Thousands of Meters by Drone Successfully


In the critical organ transplant operation, once a donor is matched, the most vital and crucial factor is the organ reaching the recipient in time, every second matters. To maximize the chances of success, organs must be shipped from A to B as quickly and as safely as possible—and a recent test run suggests that drones are up to the task.

Dr. Joseph Scalea of the University of Maryland Medical Centre organized a group of researchers, including associates at the University Of Maryland’s Department Of Aerospace Engineering, to explore whether organ delivery by drone was feasible. “I frequently encounter situations where there’s simply no way to get an organ to me fast enough to do a transplant. And that’s frustrating, so I wanted to develop a better system for doing that,” Scalea says.

Last March, they received news of the availability of a kidney—for research purposes. Over the course of roughly 24 hours, the kidney was shipped more than 1,600 kilometres to Baltimore and the drone was set up for its first delivery mission. The results were published in the IEEE Journal of Translational Engineering in Health and Medicine on 6 November.

The team selected a DJI M600 Pro for the experiment because its six motors lie directly below their respective rotors. That would keep the rotors far away from where a smart cooler containing an organ would dangle, and that separation would spare the organ from heat emitted by the motors. This particular drone can manage a payload of approximately 9.1 kg (20lbs). The drone is considered flight worthy in wind speeds of up to 32.2 km/h (20 m/h). A GoPro camera was mounted inferiorly for video data collection. The chaser drone was a DJI Inspire 1.

Next, the team designed a specialized wireless biosensor, called the Human Organ Monitoring and Quality Assurance Apparatus for Long-Distance Travel (Homal), to measure temperature, barometric pressure, altitude, vibration, and GPS location of the organ while it’s en route. With the drone and wireless biosensor ready, the researchers needed an organ to complete the experiment.

It took less than 10 seconds to successfully place the organ in the HOMAL and the artery, vein and ureter were unaffected by the HOMAL. The kidney-HOMAL unit was then packaged in the Smart Cooler for transportation. The temperature dropped to 3.9 degrees Celsius prior to active flight. Over approximately 1 hour, the HOMAL showed a stable temperature of 2.5 degrees Celsius.

Vibration and pressure changes can injure fragile human tissues. Biopsies were taken prior to and immediately after drone flights. Drone flight did not affect biopsy results.

The vital factor here is the cold ischemia time (CIT) involved. CIT is the amount of time which accumulates between organ recovery and organ transplantation. In general, surgeons attempt to transplant, for example, deceased donor kidneys with less than 24 hours of CIT and livers in less than about 8 hours. Because higher quality organs result in more life-years for the recipient, lower CITs resulting from UAS transport could add life-years to transplant recipients. Inner city drone organ transportation may be a good first-step for implementing UAS technologies.

Notably, a drone operated in the United States must currently remain within a pilot’s line of sight throughout the entire flight. And U.S. Federal Aviation Administration regulations state that a drone may not fly higher than 122 meters (400 feet) above structures within the area in which it is flying. These limitations will affect not only vital organs, but a swath of other medical supplies for which drones are being explored as a delivery method.

Although the group’s recent experiment did not involve the kidney being transplanted into a living person that is the obvious next step. Scalea suspects that such an experiment will happen in the very near future, perhaps early in 2019. “Stay tuned,” he says.

UAS applications to transportation issues have been proposed in literature but at the moment the lack of a clear and shared regulation is a drawback and obstacle to the implementation. Success with transplantation could open up the possibility of additional, future UAS applications. Beyond solid organs, drone transportation of blood products has been suggested as well. UAS organ transportation is a potentially appealing opportunity in the field of medicine.


Israeli kidney-cells startup gets backing from billionaire Kahn’s venture arm

KidneyCure Ltd., a biotech firm that uses personalized cell therapy to help improve the function of kidneys, nabs funding from investors including Morris Kahn’s Aurum Ventures

An Israeli startup that is developing a way to use a patient’s cells to treat damaged kidneys, has received the backing of the South African born Israeli billionaire and philanthropist Morris Kahn.

KidneyCure Ltd., the biotech firm that is developing a new cell-therapy technology for treating advanced chronic kidney disease, said it has completed a financing round with investors including Aurum Ventures, the technology investment arm of Kahn, and Direct Insurance Financial Investments.

The new investors join KidneyCure’s existing backers, including Jonathan Leitersdorf, Prof. John Finberg and Gilad Altshuler Holdings. The investment from Aurum Ventures and Direct Insurance brings the total amount raised by KidneyCure to $4 million.

KidneyCure is developing cell-based personalized medicine therapy that compensates for renal cell depletion by injecting the patients with renal stem cells attained from the patients’ own cells. Upon administration, these cells are expected to significantly improve kidney function, prevent the formation of fibrotic renal tissue, and delay the progression of the disease, the company said.

A substantial delay in the need for dialysis and kidney transplantation will be the expected major benefit of the treatment, the company said.

KidneyCure’s team is led by its CEO Dr. Alon Yaar, a serial entrepreneur, who served as founder and former CEO at Neuroderm, an Israeli pharmaceutical company that was bought by by Mitsubishi Tanabe Pharma in 2017 for $1.1 billion. The chief scientific and medical adviser of at the firm is Prof. Benjamin Dekel, a specialist in nephrology, human renal progenitor cells and renal regenerative medicine.

“The new funds from Aurum and Direct Insurance will enable us to accelerate our R&D process and meet the goal of completing all regulatory requirements to bring us to the start of clinical trials,” said the CEO Yaar in a statement announcing the funding. KidneyCure offers a new regenerative medicine technology for treating advanced stages of chronic renal disease “that currently have no treatment or cure,” he said.

Some 30 million people, or 15 percent of US adults are estimated to have Chronic Kidney Disease (CKD), according to the US Centers for Disease Control and Prevention, while 10% of the population worldwide is affected by CKD, and millions die every year, because of lack of access to affordable treatment, according to the National Kidney Foundation.