Drugmaker plans to improve treatment for Russia’s HIV patients using grant from Skolkovo

19 мая 2016 г.

A Russian company is hoping to revolutionise the treatment of HIV patients around the world with the help of a grant from the Skolkovo Foundation.

Currently, Russia's one million HIV patients take a daily cocktail of tablets. Viriom is working on an injection that will last for up to three months, considerably simplifying treatment routines. Photo: Pixabay.

Viriom, a resident of the foundation’s biomed cluster, plans to develop a treatment routine in which daily pills can eventually be replaced by pills or injections that will last for up to three months.

Currently, Russia’s one million HIV patients take a daily cocktail of tablets that over time can result in the patient developing a psychological aversion to the treatment and not following the prescribed routine.

“Since HIV patients receive lifelong treatment, therapy compliance is a major challenge, and the main aim right now of scientists and companies is to simplify the treatment process,” says Irina Tyrnova, general director of Viriom.

The company was awarded a 150 million ruble ($2.3 million) grant after its application was approved at the Skolkovo Foundation’s council meeting in March. The same amount was awarded in co-financing by ChemRar Ventures, a Russian venture investment company specializing in biopharma and medicine.

With the help of the grant, the aim is to develop a prolonged “sequential” HIV/AIDS therapy, Tyrnova told Sk.ru.

This would mean HIV patients taking traditional treatment – either three tablets a day in combination, or one “three-in-one” tablet – for the first three to six months to reduce the viral load. Then, when the viral load falls to a certain level, the patient would be downgraded to either two tablets or a two-in-one tablet, Tyrnova said.

Eventually, the patient would move over to having injections once a month or once every three months, she explained.

“With the support of the Skolkovo Foundation, the scientists will be able to develop a new prolonged form of Russian medicine and new treatment routines to improve patients’ adherence to HIV treatment and make it more efficient, which is an important condition of success in this disease area,” said Kirill Kaem, head of the Skolkovo Foundation’s biomed cluster.

“If the clinical trials of the new form are successful, this development will enable patients to receive treatment once a month, simplifying the treatment regime, making it safer and increasing patients’ adherence,” said Kamila Zarubina, Viriom’s project manager at Skolkovo.

Viriom, which is headquartered in Moscow and also has an office in San Diego, is not the only company working on developing this model of treatment. But amid shortages of medicines for HIV patients in Russia, and following the government’s decision last year to replace imported drugs with domestic medicines, the need for effective and safe homegrown treatments has never been so pressing.

In January, the number of registered cases of HIV in Russia reached one million, and Vadim Pokrovsky, head of Russia’s Federal AIDS Centre, has said the real figure could be as high as 1.5 million, about one percent of the country’s population. Health Minister Veronika Skvortsova says the figure is rising by about 10 percent every year.

“Other companies like Johnson & Johnson and ViiV [a partnership between GlaxoSmithKline and Pfizer] are also working on similar [prolonged effect] programmes, but there’s no product on the market yet,” said Tyrnova.

Viriom’s new treatment model could be available to patients in the next three to five years, she said, explaining that HIV drug trials are lengthy, as the effectiveness of the drug generally only becomes apparent after at least a year of treatment.

Homegrown treatment

Irina Tyrnova, general director of Viriom. Photo: Viriom.

In the meantime, the company is completing the final clinical trials of its HIV drug Elpida (elpivirine), which Tyrnova says should be on the market at the beginning of 2017. Unlike the prolonged formulations currently in development, the fixed-dose formulation of Elpida, whose name means “hope” in Greek, will not change patients’ treatment routines – it must be taken daily in combination with two other drugs for the duration of the patient’s lifetime – but Tyrnova and Kaem say it will still improve conditions for Russia’s HIV patients.

“It has several advantages: It’s more effective and safer than other drugs in its class, it’s best-in-class,” says Tyrnova of the non-nucleoside reverse transcriptase inhibitor (NNRTI).

Work on VM-1500, the innovative molecule on which Elpida is based, began in the ’90s by the Swiss pharmaceuticals company Hoffman-La Roche. When the company shuttered its HIV research, Viriom obtained an exclusive license to develop and commercialise the product. 

The drug is manufactured entirely in Russia, which is key in giving Russian patients access to innovative but affordable drugs.

“It is fully made here from scratch, so nothing is bought abroad,” says Tyrnova.

This is crucial in Russia, where HIV drug shortages are common, and where imported foreign medicines are being replaced by domestic ones under government policy.

Last year, the government pledged to double funding for combatting HIV in 2016 to $600 million. But so far, the online forum Pereboi.ru, where HIV patients across Russia share reports of drug shortages at their local clinics, is still full of people complaining that one or more of their usual medicines is not available, and that their treatment plan is constantly being changed as a result.

HIV patients in theory can buy their own treatment drugs – including imported ones – if they have the means to do so, but far from all of them do, and there is also no guarantee the drugs they require will always be available.

A patient writing on the forum from Moscow last month who identified himself as Viktor wrote: “They have changed my medicines every month since February 2015. In September the doctor gave me a prescription for only two of the three medicines, and now they have said none of them are available, and I should change my treatment plan to one that didn’t agree with me when I tried it at the start of my illness. I can’t buy the medicines myself anymore, the prices in Moscow have soared, and the medicines are not always available.”

Localised production will mean that Elpida should be cheaper and consistently available, Tyrnova said.

“Unlike medicines made by foreign manufacturers like Gilead, ViiV or GSK (GlaxoSmithKline), it’s significant that we won’t depend on the dollar rate,” she said. 

Last year, Pokrovsky said the number of HIV patients was growing faster than funding for treating them, and said the lack of funds was an issue in drug shortages. He told Sk.ru that access to medicine in Russia had not changed, and said that Russian patients currently take both Russian generics and original Russian drugs such as Phosphazide, branded as Nikavir.

Tyrnova said that patients are currently mostly given older treatments, because they are cheaper, but that they tend to be less effective or have more side effects.

“Now generics are starting to be made here, but only a couple are fully made in Russia, and they are usually quite old,” she said.

“There are a lot of patients, so the budget is only big enough for the oldest treatments,” she explained.

“They were developed years ago, and ours is more effective and safer. That’s important because the patients take the medicine for the rest of their lives, and over time, they accumulate a lot of unpleasant side effects,” she said.

The government has pledged $600 million this year to combat HIV. Photo: Public Domain Files.

These side effects can result in a psychological weariness among patients from constantly taking the drugs, which can cause them to stop their treatment. This is a vicious circle, as stopping treatment allows the virus to develop, requiring patients to undergo more complex and costly treatment.

Three in one

To make the early stage of the therapy easier, Viriom is also developing a domestic three-in-one treatment, which are in widespread use abroad but are not provided by Russian health authorities due to their high cost.

“Three-in-one is better, as it’s fewer tablets for the patients to take, and since they have to take them every day, it’s hard for them,” says Tyrnova.

The company is also investigating the potential for an oral weekly formulation of Elpida to provide pre-exposure and post-exposure prophylaxis.

Viriom, a member of the ChemRar group of Russian pharma companies, does not plan to limit sales of its drug to Russia. The company’s license from Hoffman-La Roche was originally for four markets: Russia, Ukraine, Belarus and Kazakhstan, but in 2013, the Swiss company extended the license to the drug’s commercial use throughout the world, and its makers expect it to have high export potential.

In addition to Viriom, the Skolkovo Foundation’s biomed cluster contains eight more companies working on ways to diagnose and treat HIV, including Biomedical Centre, which is working on the development of a vaccine against HIV, and AGCT, which is developing a treatment system for HIV-associated malignant tumours and HIV using stem cells and genome editing.

“The fight against HIV/AIDS is one of the most important tasks of global healthcare,” says Kaem. “A new kind of treatment always means a step forward in this fight, and new possibilities for patients.”