Kazakh-American venture capital fund promotes Kazakhstan's role as a preferred destination for clinical trials

ASTANA – FutureMed Ventures KZ, a Kazakh-American venture capital fund, aims to promote Kazakhstan's growing role as a clinical trials site and bring innovative technologies to the country, Almas Kenessary, the fund's managing partner, said in an interview with The Astana Times. He spoke about the fund's goals, a brain tissue regeneration technology it is investing in, and why Kazakhstan is on track to become a reliable base for medical innovation.

Venture capital fund based in Delaware

The fund was founded Founded in Delaware, USA, in January and has its operational headquarters in Kazakhstan, it benefits from its “unique risk mitigation concept”.

“In terms of our strategic goals, we are a venture capital firm specializing in biotechnology and medical devices. Our unique risk mitigation approach accelerates scientific progress not only in Kazakhstan, but also worldwide,” said Kenessary.

The fund targets promising developments in biotechnology and medical technology. It attracts biotechnology and medical technology companies from around the world, especially from the American market. Kenessary stressed that one of the outstanding features of the company's approach is the ability to conduct early-stage clinical trials in Kazakhstan at a fraction of the usual cost and in a significantly shorter timeframe.

Kenessary also added that the fund is focused on identifying technologies in Phase 2 clinical trials where efficacy is the primary endpoint.

Technology for stroke rehabilitation

Kenessary said the fund has invested in technologies focused on regenerating brain tissue after severe ischemic strokes. It has completed Phase 1 trials in the U.S. and is scheduled to begin Phase 2 trials in Kazakhstan in December.

“There are currently no approved technologies for regenerating brain tissue after a severe ischemic stroke,” said Kenessary

He emphasized the prevalence of ischemic strokes, which account for the majority of all stroke cases. “There are two types of strokes: hemorrhagic and ischemic. Depending on the cause, ischemic strokes account for 70 to 90 percent of all strokes. They represent a tremendous burden not only for the U.S. population, but worldwide,” said Kenessary.

According to him, the financial burden of rehabilitation after a stroke in the USA is enormous: insurance companies pay on average between 40,000 and 120,000 dollars per patient.

“We plan to conduct Phase 2b trials here in Kazakhstan. The sample size is 120 patients. This is a placebo-controlled, double-blind study. If we demonstrate high efficacy, we will apply to the FDA for conditional approval. [Food and Drug Administration] Agency, which means the U.S. population will have access to this revolutionary technology,” Kenessary said.

According to preliminary calculations, the cost of this single injection therapy is approximately $15,000 to $20,000.

“If a patient does not show significant positive dynamics within the first six months after a stroke, the chances of full rehabilitation are extremely low,” he explained. “There are cases after a severe ischemic stroke with left- or right-sided impairments. That is, people cannot brush their teeth or eat on their own. We give such patients a chance to rehabilitate and become an active cell of society again.”

Estimated schedule

The first injections are planned for December. The studies will last 12 months.

After six months, the effectiveness of the treatment is assessed and at the end of the twelve-month period the team determines whether there have been any side effects.

Once the study is completed, they plan to submit the application to the California FDA.

Since this is a Phase 2 study, Kenessary said they are seeking conditional approval.

“The final BLA [Biologics License Application] or NDA [New Drug Application] is usually approved by the FDA after a Phase 3 trial,” he added.

The study is scheduled to be completed in 2025. Kenessary said they hope to receive conditional approval by the end of 2026.

“2027 will be the year the drug will first be distributed to the U.S. population,” he said.

Clinical trials in Kazakhstan

Kazakhstan may not be the first country that springs to mind when you think of cutting-edge clinical trials, but Kenessary sees it differently. While Kazakhstan can't match the healthcare standards of the United States or Japan, it can certainly keep up, especially in certain areas like cardiovascular surgery.

He referred to the Global Health Security Index, which ranks Kazakhstan 55th among 195 countries. The ranking was developed by the Nuclear Threat Initiative (NTI), the Johns Hopkins Center for Health Security and Economist Impact and assesses countries' ability to prevent, detect and respond to infectious disease threats, including pandemics.

The GHS Index assesses countries' health security and capacity based on six categories and 37 indicators. This is Kazakhstan's ranking.

Kenessary believes Kazakhstan can easily compete with developed countries in some areas, such as cardiovascular surgery. He said that when international medical experts, such as hospital directors and vascular surgeons from the United States, visit Kazakhstan, they are often surprised by the capabilities of local facilities.

“When we bring them to our cardiovascular surgery clinics, they say that even 10% of clinics in the United States are not able to perform such sophisticated operations. In Kazakhstan, transplants of artificial hearts and ventricles are performed. We were the first country in the world to transplant one donor heart after another,” Kenessary said.

In addition, many clinics in Kazakhstan have accreditation by the Joint Commission International (JCI), the gold standard for the quality of medical services in the United States.

A key advantage that Kazakhstan offers biotech and medtech companies is the significantly lower costs and faster timelines for conducting clinical trials.

“One of our portfolio companies has developed a bioresorbable stent for peripheral arteries. Originally they wanted $15 million to do their trial in the US. I told them, 'First we'll do a super cheap and super fast trial in Kazakhstan.' They will prove the effectiveness of the stent. If all goes well, we will repeat the trial in the US,” he said.

According to him, the entire study, which will involve 60 surgeries, will cost $378,000. This significant cost reduction is possible because the cost of performing a stent implantation in Kazakhstan is only a fraction of the cost in the United States, even when using the same high-quality stents from major manufacturers.

The same procedure that costs $15,000 to $110,000 in the United States costs less than $3,000 in Kazakhstan.

Overall, Kenessary emphasized the cost-effectiveness of clinical trials in Kazakhstan.

“A Phase 2 trial costs an average of around $20 million in the US. For the same amount, we can test up to 30 technologies here in Kazakhstan,” he said.

“The price of drugs in the United States always includes all costs for unsuccessful trials,” he added. “Using international clinical sites significantly reduces the cost of trials and ultimately lowers the price of drugs.”

Speed ​​is another crucial factor. While the trial itself cannot be expedited due to compliance with FDA-approved protocols, the bureaucratic and operational procedures are streamlined.

“Today we are able to obtain approval for clinical trials within two to four months. [in Kazakhstan]In the United States, to obtain an IND [Investigational New Drug] On average, it takes nine to twelve months to be appointed,” he explained.

Kazakhstan's centralized healthcare system also offers a significant advantage in patient recruitment, a process that can be a bottleneck in clinical trials.

Kenessary noted that the company hopes to recruit 120 patients within three months for Phase 2b trials of the technology to treat ischemic stroke. This speed is possible because the company can access a central database of ischemic patients after a stroke and contact their doctors directly.

“The CEO of the company always tells me that if we were to do the trials in the United States, it would take two to three years,” Kenessary added.

Clinical trials market in Kazakhstan

Kenessary noted that the clinical trial market in Kazakhstan has undergone a transformation in recent years.

“About three to five years ago, clinical trials were considered something ridiculous or famous in society because the clinical trial market was still very underdeveloped,” he said.

However, he noted that views are changing, particularly among doctors.

According to him, pharmacogenetics – the study of how genetic differences between individuals affect their response to drugs – is a key reason why clinical trials are so important.

The full interview will be published for the first time on the Astana Times YouTube channel in September.