Hansa Gears Up In Kidney Transplant

Aug. 16, 2017 9:56 AM ETHansa Biopharma AB (publ) (HNSBF)
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Kidney transplant is the gold standard for patients with end-stage renal disease, but some have antibodies against the donor organ that make it hard for them to find a match, often leaving them on the waiting list for years.

Hansa Medical (OTCPK:HNSBF) is tackling this population with its lead project, Ides, a bacterial enzyme that eliminates IgG antibodies, designed to desensitize patients so transplantation can be carried out. Promising results from a small study were recently published in the NEJM, but the real test for Ides will come next year with the readout of its phase II HighIdes trial, which could be used to support registration.

"We try to lower the IgG levels to an acceptable level for transplantation - it opens up a window," explains Hansa's Chief Executive, Göran Arvidson. The relevance of IgG is that it is the most prevalent type of human antibody, protecting against bacterial and viral infections.

There is already a way of eliminating antibodies pre-transplant - plasmapheresis, which allows some sensitised patients to receive a kidney. But the method, which involves removing plasma from a patient and replacing it with new plasma or saline solution, is far from ideal, according to Mr. Arvidson.

"Plasmapheresis takes a long time, you have to repeat the treatment many times to prepare the patient for maybe a couple of weeks before transplantation," he tells EP Vantage. "We've demonstrated that Ides can, very effectively and within hours, inactivate IgG."

Still, this presumably raises the risk of leaving patients immunocompromised, though Mr. Arvidson insists: "Ides eliminates antibodies temporarily: IgG starts to come back at between four and seven days and, on average, is back at original levels three to four weeks post treatment."

He adds that the group has not seen an increase in infections in the five clinical trials carried out so far, and that Ides does not cleave other isotypes of antibodies.

Speed

Ides's fast onset of action also means that patients treated with it can receive organs from deceased donors; because of the time it takes, plasmapheresis only allows living donor transplants, which are harder to come by.

This appears to be backed up by the recent NEJM publication: Ides was given to 25 highly human leukocyte antigen (HLA)-sensitised patients who then received a transplant from an HLA-incompatible donor. All but two of the organs came from deceased donors, according to Mr. Arvidson.

24 of the patients had good kidney function six months after the procedure, while one transplant failed because of the presence of non-IgG antibodies, according to Hansa.

The results bode well for the ongoing phase II HighIdes trial, which is due to report results in the first half of next year and could support approval, at least in the most severely affected patients.

"We're targeting really difficult patients, those who today cannot be transplanted even with currently available methods like plasmapheresis," says Mr. Arvidson.

The single-arm trial will evaluate Ides's efficacy using the crossmatch test, which ascertains whether a patient has antibodies to their donor. "If the test if positive you cannot go ahead with the transplantation," the chief executive explains. "The primary objective is conversion of a positive crossmatch test to a negative one."

When asked what proportion of patients would need to convert for the trial to be considered a success, he replies: "I'm pretty confident that we can convert the crossmatch test to negative in the majority of patients, if not all."

If successful, Hansa will initially be targeting a relatively small population - of the roughly 100,000 US patients on the waiting list for a kidney transplant around 9% are so highly sensitised that finding a suitable donor is almost impossible, it says.

New indications

Eventually, though, Ides could be used more broadly, in sensitized and moderate patients. And Hansa is already looking into new indications within kidney transplant, including ABO-incompatible cases, allowing transplantation regardless of blood type, and treating post-transplant antibody-mediated reactions. Ides could be a $600m product within kidney transplantation, Mr. Arvidson estimates.

Beyond this, Ides might have utility in autoimmune diseases where plasmapheresis is currently used to remove problematic antibodies. Hansa has already started a trial in anti-glomerular basement membrane, or Goodpasture's disease, with results expected in 2019, and it is also interested in Guillain-Barré syndrome.

Mr. Arvidson says transplantation and these two additional uses will be pursued in-house: "It's a relatively limited number of patients so you don't need a huge infrastructure. But we're evaluating regional partnerships and we're also looking to [new] indications. We're open-minded to that."


Ongoing Ides trials
Indication Study Trial ID Data due
Kidney transplant HighIdeS NCT02790437 H1 2018
Kidney transplant Phase II Cedars-Sinai-led trial NCT02426684 H1 2018
Anti-GBM disease Good Ides NCT03157037 H1 2019

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