The bad thing is that post Brexit, it seems that the MHRA has gotten a bit backlogged and isn’t able to keep up with our current demands on their time. It takes too long to get meetings and responses to applications currently. We’ve had to take our first human clinical trial to Australia, where it’s a faster, more streamlined, and cheaper process.
I think Insilico has opened an office in the middle east (don’t remember the country). I can see some countries deciding that testing drugs could be a growth industry for them.
"Cyclodextrins, the core chemical structure of UDP-003, are cyclic sugar-based molecules capable of encapsulating lipophilic compounds such as cholesterol. While some forms of cyclodextrins have been used as excipients or in experimental cholesterol efflux therapies, the dimeric structure of UDP-003 confers around 1,000-fold greater selectivity for 7KC over cholesterol, according to the authors [1].
This selectivity appears to be central to the compound’s ability to remove 7KC from human atherosclerotic plaque tissue in as little as 15 minutes, and to promote urinary excretion of the toxin in vivo. Notably, these effects occurred without significant toxicity; UDP-003 has completed a suite of preclinical safety studies and is now considered ready for clinical development."
7-Ketocholesterol (7KC) is a toxic oxysterol formed by the non-enzymatic oxidation of cholesterol that accumulates in atherosclerotic plaques, driving arterial damage by turning macrophages into foam cells and triggering inflammation, oxidative stress, and cell death. Selective removal of 7KC from arterial tissue is currently being developed as a therapeutic approach, with the dimerized cyclodextrin compound UDP-003 demonstrating the ability to extract 7KC from human plaque-laden arteries more effectively than monomeric cyclodextrins.
Mechanism of Harm : 7KC cannot be properly digested by cells, leading to lysosomal dysfunction, autophagy impairment, and the accumulation of lipid-filled foam cells that destabilize plaques and cause arterial blockage.
Therapeutic Strategy : Direct removal of 7KC from within cells is considered the only effective method to reverse foam cell formation and prevent atherosclerosis progression, as antioxidants or drugs targeting circulating oxysterols do not reach intracellular deposits.
Current Development : A Phase 1 clinical trial is underway for UDP-003 , a novel therapeutic candidate designed to sequester and remove 7KC from foam cells, potentially rejuvenating macrophage function and reducing plaque burden.
To obtain the specific chemical synthesis procedures, you would need to access the full text of the primary research article, “Cyclodextrin dimers: A versatile approach to optimizing encapsulation and their application to therapeutic extraction of toxic oxysterols” , published in the International Journal of Pharmaceutics in 2021.
I’m not surprised that it’s safe, cyclodextrins are considered safe and this is just them hooked together. So that’s one hurdle.
I told my doc I couldn’t wait to get it in a few years and he went on and on about the drugs he had waited for then they failed or caused harm then failed. Basically telling me to not get my hopes up.
I feel like this is the equivalent of mechanical removal of weeds. Like nearly foolproof. It pulls out the bad guys without reacting with anything else. I know there could be a surprise, but still believe this is good stuff.
The only thing I didn’t understand is when they said they still want investors. I thought it was private and not possible to invest. Does anybody know of the way to invest? Where is it sold?
It is a private company, but just like OpenAI and Anthropic, there are many investors… but you have to be a specific type of investor. Mostly its going to be venture funds (venture capital), but it may also be private equity funds, or even just wealthy people investing (you have to be an “accredited investor” meeting specific wealth levels to invest in these “unregistered” securities (not on the stock exchanges).
The cost of the next phase of trials, phase 2 clinical trials, go up a lot compared to phase 1 clinical trials. Phase II trials range from $7-20 million total, so they need this amount of money to run that trial, and so are raising for that round right now.
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