Vaginal Drug Delivery—The Future

Lara Zibners MD MMed MBA
Co-founder and Chairman

Things are busy over at Calla Lily Clinical Care! The office is buzzing with all hands-on deck as we prepare for our first in-women trial delivering progesterone via our leak-free Callavid® vaginal drug delivery device. I’m not joking when I saw “all hands-on deck.” Thang Vo-Ta has packed our office to the brim this summer. We’ve had to shift from hybrid to more days in our office and labs. There is so much to do—and believe me when I say I really had no idea how much detail goes into every part of this. The regulatory considerations. The patient information pamphlet. The materials. The supply chain. The packaging decisions. The data collection. The patient recruitment. What kind of coffee beans go into the office machine. (No, that matters too. Need my crew alert and happy.) Every single day, every single decision, is vital to our success and the team is killing it.

This is super exciting. I’ve talked about the reasons for intravaginal drug delivery before. Right drug, right place, right dose, no nasty side effects or hideously painful needles.

I’ve also talked about some of the medications that can be delivered vaginally. These are the ones you are already familiar with, like progesterone, estrogen and The Yeast Beast therapies.

But what else is out there? Our aspirations for Callavid go well beyond infertility and miscarriage support. There are so many opportunities for vaginal drug delivery, both already in existence and currently in development.

Remember when my sister said “Oh I get it! You guys are the juice box. A juice company asks you to put their juice in your box and then that box goes in my vagina.” So what other flavor juices are we eyeing?

Here’s just a few. Let me know which is your favorite.

Vaginal microbiome support. That’s so exciting that I’m leaving that for another day. Watch this space. I’ll just say that there are challenges in creating a healthy vaginal microbiome and sitting in yogurt or eating pineapple gummies are not the way.

Oncologic (cancer) therapeutics. There are a number of really exciting companies out there looking at novel localized treatments for cervical cancer, which is the 4th highest-ranking cancer-causing morbidity and mortality in women. Globally, over 340,000 womendie every year.  Wouldn’t it be amazing if we had great new drugs that could target cancer cells where they are living without all the systemic side effects of traditional chemotherapy? I happen to know a few companies looking at just that. But you know what they need? A better way to deliver the drug without leakage and completely hygienically.

In fact, here’s a great article about vaginal drug delivery specifically for cervical cancer. And if you keep reading, it says (and I am not making this up) “…the disadvantages of these formulations, such as ease of leakage and short residence time of vaginal gels, lead to poor efficacy which cannot satisfy the demand for the treatment of cervical cancer or CIN.”

Let me translate. What they mean is “we need a device like Callavid  to hold these leaky drugs in place and make sure the medication gets to the right spot while absorbing the icky leftovers.” What’s that? You’re looking for a team with the ability to bespoke integrate a medication into a scaffold so that drug is released while leakage is absorbed? Hmmm, I think I know someone you could call…

And lastly for today, what about novel treatments for endometriosis? There are both new drugs in the pipeline and the old standard treatments, one of which is progesterone. But what about something like danazol? It is highly effective but has largely been replaced with newer generation GnRH agonists because of the systemic side effects. Yes, your danazol works great, but it will sort of turn you into a man. Okay, I’m exaggerating, but a deepened voice and unusual hair growth aren’t for everyone. There is great evidence that vaginal danazol could be used for endometriosis but it’s an old drug. Not sexy. No interest. What is we could find a way to make danazol sexy again by integrating it into a convenient, leak-free scaffold for selective delivery to the target tissues without giving you a moustache? I think we’d be on to something!

So there you have it. Some “juices for the juice box.” What’s your favorite? Got any other suggestions? Because progesterone is just the tip of the iceberg.

REFERENCES

https://www.theguardian.com/society/2023/sep/11/the-vaginal-microbiome-how-to-look-after-it-and-what-to-avoid

https://www.sciencedirect.com/science/article/pii/S2667005425000134#:~:text=Results,and%20mortality%20in%20women%20worldwide.

https://www.sciencedirect.com/science/article/abs/pii/S0014299922000127

https://www.sciencedirect.com/science/article/abs/pii/S0169409X21001095

https://www.mayoclinic.org/diseases-conditions/endometriosis/symptoms-causes/syc-20354656

https://www.sciencedirect.com/science/article/abs/pii/S1701216316300755#:~:text=The%20available%20evidence%20shows%20that,as%20possible%20improvement%20in%20fertility.

https://www.mayoclinic.org/drugs-supplements/danazol-oral-route/description/drg-20067988