Our surgical site infection (SSI) prevention and treatment program includes a pipeline of biodegradable, polymeric core-shell microparticle and nanoparticle products for the controlled and extended, local delivery of existing antibiotics designed to offer an alternative means of antibiotic prophylaxis for both Gram-negative and Gram-positive bacterial infections. It is our belief that systemic antibiotic prophylaxis and treatment regimens, in healthcare associated infections (HAIs) and SSIs, are among the major contributing factors leading to the problem of drug-resistant bacteria. Thus, at the heart of the program is our belief that local infections should be treated with a local intervention.
Our biodegradable, polymeric core-shell particles are engineered to possess a polymeric shell with desired material science properties to control the release of multiple antibiotics via diffusive and degradative mechanisms. Following release of the antibiotics, the particles biodegrade through interaction with water, leaving no residual.
Ultimately, our approaches are intended to enable either synergistic action or a more rigorous broad-spectrum approach for prophylaxis.
Anti-infective Program: Approach #1Biodegradable, polymeric core-shell particles are engineered to exhibit several important physicochemical characteristics. These particles are designed to enable efficient encapsulation within and controllable, simultaneous sustained release of multiple antibiotics from the hollow core. These products are lyophilized and terminally sterilized to enable administration via injection or instillation. The target efficacy duration for these products is 7-10 days.
Anti-infective Program: Approach #2Biodegradable, polymeric core-shell particles are engineered to exhibit several important physicochemical characteristics. These particles are designed to enable efficient encapsulation within and controllable, simultaneous sustained release of multiple antibiotics from both the hollow core and the polymeric shell. These products are lyophilized and terminally sterilized to enable administration via injection or instillation. The target efficacy duration for these products is 7-10 days.
Our non-opioid pain management program includes a pipeline of biodegradable, polymeric microparticle and nanoparticle products for the controlled and extended, local delivery of existing, non-opioid analgesics designed to offer alternative means of acute and chronic pain management than those interventions which have been conventionally utilized as standards of care. It is our belief that sustained peripheral nerve blocks (PNBs) performed with the right analgesics have the potential to completely change the paradigm for surgeons and anesthesiologists tasked with management of post-surgical and chronic pain indications. Thus, at the core of our pain program is the appropriate selection of high potency, non-opioid analgesics with ideal mechanisms of action that when delivered locally have the capability to be therapeutically effective without the risk of systemic side effects.
Biodegradable, solid matrix polymeric particles are engineered to possess desired material science properties to enable efficient entrapment and controllable release of analgesic(s) via diffusive and degradative mechanisms. The particles biodegrade via bulk erosion with water, leaving no residual.
We select and control the particle size and polydispersity to enable:
- Controllable release of the analgesic(s) with rapid onset of therapeutic efficacy,
- Control over particle residence time in and clearance from the site of administration,
- Mitigation of foreign body response, and
- Administration without changing the standard of care for PNBs.
These products are lyophilized and terminally sterilized to enable administration via injection or instillation. The target efficacy durations for the post-surgical and chronic pain management products, are 7-10 days and up to 60-90 days, respectively.
In post-menopausal women, the decreasing levels of estrogen cause (1) a thinning of the superficial cells and stratified squamous epithelial cells that line the vaginal mucosa and (2) a decrease in squamous epithelial glycogenation, resulting in a decrease of exfoliated, glycogenated cells. Glycogen is an important biomolecule that is responsible for maintaining vaginal health. The conversion of glycogen to lactic acid by Lactobacilli, the beneficial flora of the vaginal mucosa, is essential for maintaining the healthy, low vaginal pH. In the absence of glycogen, the vaginal pH rises, resulting in a decrease in Lactobacilli and a potential for overgrowth of harmful bacteria that can lead to infection and inflammation. Further, the decline in estrogen levels leads to decreased vulvovaginal blood flow, decrease mucous production, and decreased vaginal lubrication.
The initial product, ATX-001, formulation will serve as the base formulation across all our pipeline products, as this base formulation is designed to easily incorporate active ingredients to create a pipeline of over-the-counter (OTC) and prescription products across a number of vaginal health-based pathologies. Given that the ATX-001 formulation is designed to create a unique interface with the vaginal mucosa, our scientific team believes that this formulation will lead to increased absorption and transport of small-molecule, active pharmaceutical ingredients.