Exciton Pharma | Carla Spina, CSO

(Transcription)

Carla Spina  0:00  

I wanted to first stop and thank Mohammed, Scott and the LSI team. For this incredible event. I have been both inspired and invigorated by the medical advancements presented here, knowing that they will undoubtedly become the medicine of the future. And as CEO and co founder of Exciton Pharma, I'm here to show you today, how I will be tackling one of the biggest unmet needs that is notoriously complex and challenging diabetic foot ulcer infection. Four of the nearly $240 billion spent on diabetic care in the US alone 1/3 of those costs is associated with foot disease, for up to 33% of diabetics will experience a foot ulcer in their lifetime, and up to half of these will become infected, nearly doubling the cost of care. Now, what we know is that now is that most of these infections contain biofilm a recalcitrant form of infection associated with extensive drug resistance, chronic inflammation and stalled healing. Yet, and without the mechanisms to address biofilm, the standard of care systemic antibiotics fails to address this need. And so I'm here today to show you how we are positioned to both address and meet this challenge. For as many said on the first night, some rewards are worth the risk. And we are here to turn the tables on the antibiotic market. So let's move back to the problem. It may not surprise you now to know that up to 50% of antibiotic treatments are ineffective. Think about that for one minute, the next time that you enter a hospital. For antibiotic treatment, there's a 50/50 chance that those antibiotics will not work. And this leads to a massive drain on the healthcare resources with up to 40% of hospital beds occupied by patients with wounds. This translates into 15% of Medicare beneficiaries and leads to up to 16% of Medicare costs associated with wound and wound infection. But this is only half the problem. We are met conventional anti air conventional pharmaceutical companies address infection and healing independently. However, these concepts are not mutually exclusive. Where there is an infection there is a wound and we are here today to disrupt this convention with a singular therapeutic solution. At Exciton Pharma. We are redefining the standard of care in anti infective treatments, providing lasting solutions to improve the lives of patients living with complicated infections. Our solutions will fundamentally change the approach to treating infection, leveraging both our IP from our first in class compounds and our drug delivery systems. Our lead composition is entering phase one B studies next month, and will be the first dedicated treatment to diabetic foot infection while our pipeline composed of a library of small patent pending molecules will afford first and class treatments for inflammatory skin disease. And how are we able to do this? Well, our ad non traditional anti microbials simultaneously moderate modulate inflammation attenuating the host inflammatory response. Indeed within invivo murine and uninfected wound models, we decrease recruitment of neutrophils and macrophages to the wound site upon initial injury and over the course of five days. All while providing broad spectrum anti microbial therapies are effective against gram positive gram negative yeast and fungi, including those that have identified as critical pathogens by the CDC and the who, as well as that big killer biofilm. Our compounds afford complete eradication of biofilm within an in vivo porcine model superior efficacy to conventional approved drugs, all while affording a null resistance profile, even at sub lethal concentrations over extended exposure. All while endogenously promoting human growth factors to accelerate the healing process and As demonstrated both in vitro and in vivo through a novel therapeutic target, distilling down the complexity of infection and healing into one unified course of care, affording us a unique position within a very complex competitive landscape, positioning us not only to treat infection, but also a wide array of inflammatory skin diseases. With our first target market, focused on diabetic foot infection, we know that the current standard of care systemic antibiotics is ineffective against biofilm. We're up to 80% of diabetic foot infections contain biofilm. This infection precedes 85% of amputations and is the leading cause of hospitalization in diabetic patients. And to achieve this, were leveraging over 100 years of experience in wound care. In addition to support from non dilutive funding partners, and an ever growing advisory network, our team has had successful exits and global licensing agreements within the wound infection and pharma space, where I myself have been in med tech for nine years, bringing over five class or class two class three medical devices for market in nine countries globally for the management of chronic wounds. And it was during this time that I identified therapeutic aspects of our active ingredients for the treatment of infection. Indeed, within a simple device configuration, our active ingredients were able to advance diabetic foot ulcer infection, not progressing under the current standard of care, affording a comparable clinical response to systemic antibiotics. However, we knew that we could do better. In 2016, we spun it out this pharma company, reformulating our active ingredients under new IP composition of matter to afford a drug composition capable of completely eradicating biofilm in vivo. providing us with the confidence to lead take our advanced our lead into clinical studies for the treatment of mild and moderate diabetic foot infection. We know that globally, diabetes is a growing problem. With over $7 billion market and growing over the net but to 11 billion by 2026. We have made that strategic decision to focus on the American market first mild and moderate diabetic foot infection with a clear regulatory path and pre ind meeting establishing our primary endpoints as well as our clinical trial design. We are structured to penetrate the market to 40% within five years, securing over half a billion dollars in sales by 2029. And projected sales of nearly a billion within 10 years. And this is just for our lead configuration. In our primary indication. We have ours will be seeking secondary indications for lead, as well as additional revenue streams anticipated for our pipeline supported by our IP encompassing both the active pharmaceutical ingredient and the drug delivery system. Our precede and non dilutive funds have advanced our lead drug candidate through preclinical studies, again, moving into Phase One B studies next month, following a pre ind meeting to verify endpoints. And our milestones will include have included completion of lead ID identification for our pipeline, focusing on atopic dermatitis as our primary indication for our pipeline. However, it is with the urgent need for novel antibiotics that we are really leveraging our advancement forward. The current incentives from the FDA and the CDC have spurred regulatory and reimbursement incentives for novel anti microbials capable of combating resistance combating resistance, translating to a renewed interest from big pharma for de risked mid to late stage clinical assets. And again, with our clinical study design cleared by the FDA, and critical next steps verified with potential strategic partners. For both our lead and our pipeline. We are ready to jump to the next inflection point. Leveraging these government incentives we are currently seeking 3 million in seed for plans to complete our phase one studies by q4 2022 and advance our pipeline into animal disease models to move to the next stage of discussions with strategic partners readying us for phase two to commence q1 2023. And to advance our lead into Phase One by q2 2023. moving us into a position to secure strategic pharma partners aligned with a merger acquisition by 2025. At Exciton Pharma, we are transforming the approach to infectious disease, disrupting convention while empowering patients to regain control over their own unmet needs. Thank you very much for having me. It's been a pleasure to be here.