SUSTAINED NANO SYSTEMS, LLCsmall answers to big problems
An interview with Barry Libin, DDS, MSD & MS at the 2019 Biotech Showcase in San Francisco.
The initial SNS candidates for FDA approval are:
SNS-SA: A sustained delivery ophthalmic injection indicated for the treatment of postoperative inflammation and reduction of ocular pain for patients who have undergone cataract surgery, utilizing extra-ocular administration. At this point only eye drops taken several times a day are being utilized. There is no FDA approved extraocular single administration of an anti-inflammatory drug that is to be taken following the over three million cataract surgical procedures performed each year in the U.S. This is a three month Phase II clinical study.
SNS- LA: indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, utilizing extra-ocular administration. Only eye drop application, taken several times a day for a patient’s lifetime, has received FDA approval.
SNS-Retina LA – A long acting anti-VEGF treatment for cases of age-related macular degeneration (AMD). AMD is the leading cause of vison loss in people fifty years of age or older in the United States. Treatment would include a single intra-ocular injection every six to eight months, significantly reducing the present treatment of one intraocular injection every four to eight weeks.
SNS technology, initially designed for small molecules, is now being adapted to allow delivery of protein therapeutics. This includes such important macromolecules as anti-angiogenic antibodies, oligonucleotides, trans-gene expression products and growth factors, all of which have immense therapeutic value. An example is in delivering monoclonal antibodies (anti-vegf) drugs to the back of the eye to treat serious visual impairment, including age-related macular degeneration and macular edema, leading causes of blindness affecting over eight million people in the United States.
As SNS has reported long term bioactivity of monoclonal antibodies that treat retinal disease, it is now applying the same platform to deliver similar human engineered antibody based drugs for cancer therapy. SNS believes that immunotherapy will play a significant role in cancer treatment.
With the majority of biologic drugs treating chronic conditions, such as cancer, the need to provide consistent, long term, sustained delivery of monoclonal antibodies and other immunotherapies becomes essential. The SNS Platform Technology has the potential to satisfy this need, and provide a new therapeutic alternative to short term, multiple dosing of pharmaceutical agents. The powerful physiological effects of antibodies, hormones, enzymes and other biologic drugs suggests such delivery may provide the advantage of lower therapeutic concentrations, while increasing safety and compliance.
The following drugs are now being studied:
Dex-SA™ (Short Acting), following cataract surgery, is a short-acting steroidal anti-inflammatory drug in a SNS Particle Conversion formulation. It is intended for continuous drug delivery for a duration of 3 weeks following cataract surgery. Dexamethasone is indicated for the treatment or prophylaxis of post-operative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Currently only eye drops typically administered 1-4 times per day are available. DEX-SA is administered by a single extra-ocular injection at the time of surgery.
TM-LA™ (Long Acting) is indicated for the reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension. There is no long-acting formulation in this category. TM-LA is administered by a single extraocular injection at the time of surgery. Its controlled release of the active agent for six months to a year, provides an important market need in replacing the more burdensome and potentially less compliant regimen of daily eye drops applied for a lifetime. Glaucoma is the second leading cause of blindness in the US, and presents a significant opportunity to fulfill unmet medical needs. As glaucoma is an adult disease, the patient pool is expanding as the population ages. It is estimated that over 2.2 million Americans have glaucoma and 60 million worldwide.
SNS CANNABINOID LA™ : SNS is carrying out research on the use of medical cannabis, utilizing the cannabis plant and its constituent cannabinoids to alleviate symptoms of a number of medical conditions, including glaucoma and seizure activity.
SNS Advantage: Current methods of delivery are limited to smoking, vaporizing, oil, capsule, cookies and by oral mucosal spray. However, the continuous need for local drug administration in chronic conditions has proven difficult for continuous patient compliance. To alleviate this problem, SNS is utilizing its patented delivery system to incorporate cannabinoid into its particles to allow for a sustained dose that can last for days, weeks or months, depending upon physician orders.
Dexamethasone Release Kinetics
This graph depicts the in vitro dexamethasone release kinetics for short term use following post-cataract and inflammatory states. At 20 days, it appears that complete dissolution has occurred. This is to replace eye drop therapy.