From Soviet antihistamine to Alzheimer's breakthrough: a UK biotech bets on a molecule the world forgot
A small UK-registered biotech company believes it has found an Alzheimer's treatment that is safer, cheaper and more effective than anything currently on the market — and it has done so by revisiting a molecule that Soviet chemists first synthesised in the 1970s and that Pfizer abandoned as a failure in the early 2000s. The drug candidate, DMB-I, is now entering phase 3 clinical trials after phase 2 results showed it significantly outperforming memantine, the most widely prescribed Alzheimer's treatment in the world. The company behind it, BIGESPAS Ltd, is aiming for a commercial launch by 2028.
A disease without a solution — and a market without one either
The backdrop to this story is a global health crisis that is, by any measure, accelerating. Alzheimer's disease is on course to affect tens of millions more people by 2050, driven by two converging forces: a rapidly ageing population — the disease typically presents at 60 and above — and improved diagnostics that are reclassifying vast numbers of previously miscategorised dementia cases. "Many people who were diagnosed with old age dementia — only recently did specialists start differentiating that clearly from Alzheimer's," said Dr Boris Gorin, the scientist at the centre of the DMB-I project. "Advanced diagnostic techniques show that the number of cases is growing."
The pharmaceutical industry has largely failed to keep pace. The existing standard of care — dominated by drugs such as memantine and donepezil — provides modest symptomatic relief at best. The most high-profile recent attempt at a step change, Biogen's biologic treatment Aduhelm, received conditional FDA approval in 2021 and briefly added $19bn to Biogen's market capitalisation. But it cost $100,000 per patient per year, required intravenous administration in a clinical setting and carried serious safety risks including brain bleeds. It has since been largely withdrawn. The market, in short, is enormous, undersupplied and in desperate need of something that actually works at a price ordinary patients can afford.
BIGESPAS believes DMB-I is that something. The question is whether anyone will trust a drug developed out of post-Soviet science in the current geopolitical climate.
The credibility problem
The name Trofim Lysenko does not appear in any of the company's marketing materials, but it looms over any discussion of Russian science in the West. Lysenko, the Soviet agronomist whose ideologically driven pseudoscience set Soviet biology back decades, has become shorthand in western scientific circles for the dangers of politicised research from that part of the world. More recently, Russia's announcement of a cancer cure that failed to materialise, and the Kremlin's promotion of Sputnik V — a Covid vaccine that never received European Medicines Agency approval despite widespread use elsewhere — have deepened western scepticism about bold claims emerging from the former Soviet space.
The founders of BIGESPAS are acutely aware of this. Their first and most emphatic response is structural: this is a British company. "The fact that it was tested in Russian clinical trials does not mean it is a Russian product," Gorin said flatly. The company is registered in the United Kingdom, and its co-founder Pavel Shmarenkov — an economist and fintech entrepreneur by background — is equally direct in rejecting the Sputnik parallel. "That was an emergency situation with extraordinarily high competition," he said. "Scientific results are multinational. One plus one equals two everywhere, not only in Russia."
The decision to conduct clinical trials in Russia was, they insist, purely financial. Russian trials cost approximately one tenth of equivalent Western studies. For a small, self-funded biotech without the backing of a major pharmaceutical company, that differential is not a minor consideration — it is the difference between running the trials at all and not running them. "We did it on our own, with our initial investors," Shmarenkov said. "We needed to verify the hypothesis that DMB-I is a real, strong product before going further."
The science: a question of shape
To understand why DMB-I might succeed where previous attempts failed, it helps to recall one of the most consequential — and most disturbing — episodes in 20th-century pharmaceutical history. Thalidomide, widely prescribed in Britain and Europe in the late 1950s as a treatment for insomnia and morning sickness, caused severe birth defects in thousands of children. The reason, understood only later, was that the drug existed in two mirror-image molecular forms — what chemists call enantiomers — one of which was therapeutically useful and one of which was catastrophically harmful. The physical shape of a molecule, it turned out, was not a secondary detail. It was everything.
DMB-I's story is a variation on this theme, though with a happier trajectory. The underlying molecule, latrepirdine (also known as Dimebon), has been known since the 1970s, when it was developed in the Soviet Union as an antihistamine. It is chemically identical across all its forms — the same atoms, the same bonds. But like many pharmaceutical substances, it can exist in different crystalline structures, known as polymorphs. Think of graphite and diamond: both are pure carbon, but their physical properties could hardly be more different. One is soft and black; the other is the hardest natural material on earth. The difference is purely structural.
Pfizer identified several polymorphs of latrepirdine when it ran its phase 3 clinical trials in the early 2000s — and the trials failed. What Gorin realised, while working on an unrelated polymorphism study in Canada around 2019, was that Pfizer had not found all of them. "I screened for all possible polymorphs using modern techniques and found one that Pfizer had not reported," he said. "The hypothesis came to life: could it be that Pfizer missed the most active polymorph?" Preclinical testing on animal models confirmed that the newly identified form — named DMB-I — was significantly more active than any of those Pfizer had studied. Gorin is careful not to frame Pfizer's failure as negligence. "I would not call it a mistake. I would call it tough luck." The screening techniques now available were simply not as comprehensive in the early 2000s. Pfizer did not know what it was missing.
What makes DMB-I specifically superior is its solubility. The new polymorph dissolves and penetrates the gastrointestinal wall faster than its predecessors, reaching the bloodstream more rapidly and building up in brain tissue more effectively. This matters enormously for an oral drug — one taken as a pill rather than administered intravenously — because the absorption efficiency of oral medications varies widely, and a compound that passes through the gut too slowly may never reach therapeutic concentrations in the brain at all.
Phase 2 clinical trials, conducted across 135 patients over 26 weeks, established the optimal dosage at 20mg taken three times daily and compared the drug's performance directly against memantine. "The short answer is yes — it is way more effective than memantine," Gorin said. The improvements observed spanned three domains: cognitive alertness, social communication — which Alzheimer's patients frequently lose entirely — and what Gorin calls operational ability, meaning the capacity to perform basic daily tasks independently. Side effects were negligible, limited to a mild aftertaste. "Next to nothing," Gorin said. The drug does not cure Alzheimer's — no drug does — but its symptomatic impact, based on phase 2 data, appears to be meaningfully greater than the current standard of care, with a safety profile backed by decades of use of the base molecule as an antihistamine.
The business case: cheap, oral and ready for a gap in the market
The commercial logic behind DMB-I rests on a set of conditions that are, for a drug developer, unusually favourable. The Alzheimer's treatment market is large and growing. The existing options are either modestly effective legacy drugs or expensive, inaccessible biologics that most patients cannot afford and most healthcare systems struggle to fund. DMB-I is oral — a pill taken at home, requiring no hospital visit, no intravenous line and no clinical supervision. That alone dramatically reduces the cost of treatment and the burden on patients, who are, by definition, elderly and often frail.
"Only a very small segment of the aged population can afford extremely expensive biologics," Shmarenkov noted. "Most rely on affordable drug products." The memory of Aduhelm — a drug whose $100,000 annual price tag provoked a public backlash and a Medicare coverage dispute even as its clinical benefit remained contested — casts a long shadow over the biologics market. A drug that demonstrably works, is safe, can be prescribed by a GP and taken at home, and costs a fraction of the current alternatives, represents a genuinely different proposition.
Phase 3 trials, targeting between 500 and 700 patients across multiple confirmatory studies, are planned to begin this year and run for 52 weeks — one year, compared with the 26 weeks of phase 2. The extended duration will allow the team to observe longer-term effects and to test DMB-I in combination with other medications, which phase 2 protocols did not permit. If results are positive, a regional commercial launch in the Eurasian market — Russia, Kazakhstan, Uzbekistan and neighbouring countries — is targeted for 2028. "You cannot get approval in one country today and start selling everywhere the next day," Shmarenov said. "That is not how the industry works."
The longer-term strategy is standard biotech: prove the asset in markets where regulatory approval is more accessible, build a commercial track record, then sell or partner with a major pharmaceutical company capable of global distribution. "Independently, we will not be able to penetrate the western market," Gorin said with characteristic candour. "It can be a partnership, a sellout, an IPO — but it has to be through interaction with big pharma." The Eurasian region may be retained independently under any such deal, given the team's existing relationships and infrastructure there. Canada — where Gorin has lived and worked for thirty years — is identified as the most likely first Western market entry point, with the European Medicines Agency and the FDA representing the larger but more complex targets beyond that.
Geopolitics and the long road West
The path from promising phase 2 results to a pharmacy shelf in London or Toronto runs directly through a set of obstacles that are as much political as scientific. Western regulators, particularly the FDA, have historically required that trials submitted for approval be conducted under their own protocols and on their own soil — meaning that however compelling the Russian data, an entirely separate set of studies may be required before the drug can be considered for Western markets.
Then there is the broader question of perception. Whatever the structural argument about British incorporation, the scientific roots of DMB-I lie in Soviet-era chemistry, its trials were conducted in Russia, and its initial commercial launch will be in the post-Soviet space. In a geopolitical environment defined by deep mistrust between Russia and the West, that is not a neutral provenance for a drug seeking FDA or EMA approval — however strong the underlying data.
The founders' counter-argument returns, ultimately, to the science. The molecule does not have a nationality. The clinical results are what they are. And the market they are addressing — hundreds of millions of people globally, most of them with no access to effective treatment — is not going away. "If it works, it works," Gorin said. "I don't see why western countries would not be interested in a product that works."
That confidence may prove justified. Or the journey from a Soviet antihistamine to a western pharmacy shelf may turn out to be longer and more complicated than a promising phase 2 trial suggests. Phase 3 will begin to provide the answer. In a year or two, as Gorin put it, the world will start to hear something. The question is whether it will be listening
