Developing live biotherapeutics products for diseases of high unmet medical need
Our unique platform is designed to address multiple targets across a wide range of diseases. With clinical studies underway for allergic disease, we are broadening our portfolio in the “maternal-infant axis” with the addition of new programs for bacterial vaginosis and necrotizing enterocolitis. Siolta’s expanding IP portfolio consists of 4 issued and 18 pending patents.
- STMC-103H (Atopic Diseases)
- STMC-105 (BV)
- STMC-106 (NEC)
The Power to Prevent
Allergic diseases, including atopic dermatitis, food allergy, allergic asthma, and allergic rhinitis, have a common underlying inflammatory cascade and often occur in a sequential order referred to as “the atopic march.” STMC-103H, also known as adored: allergic disease onset prevention study, is Siolta’s proof of concept study aimed at stopping allergic disease before it’s starts by targeting early intervention of infants at high risk for developing allergic diseases.
For more information please visit http://adoredstudy.com.
Atopic Disease Prevention
Atopic Dermatitis Treatment
In addition to prevention, Siolta has plans to investigate the effectiveness of STMC-103H in treating established atopic dermatitis in infants.
A New Class of Medicines
The current standard of care treatments such as antihistamines, steroids, bronchodilators, and biologics, target the downstream inflammation that results from an inappropriate immune response. In contrast, Siolta Therapeutic’s microbiome-based approach towards atopic diseases aims to prevent the initiation of the immune dysfunction cascade, thus preventing allergic disease before it starts. Our preclinical proof of concept studies provide evidence that oral supplementation with STMC-103H has the potential to alter the gut microbiome, reprogram metabolism, reduce immune activation, and thus protect against allergic inflammation
STMC-105 – Prevention of Recurrent Bacterial Vaginosis (BV)
Bacterial vaginosis is one of the most common women’s health conditions, impacting up to 50% of women globally. Bacterial vaginosis is associated with disruptions to the protective community of bacteria in the vaginal tract and the colonization by opportunistic microbes. Standard of care treatments using antibiotics can be effective at treating bacterial vaginosis by reducing microbial burden, however these approaches fail to address the critical need to establish a stable and protective microbiota for long-term vaginal health and prevention of disease recurrence. To address this unmet need, Siolta Therapeutics is applying deep characterization of metabolic crosstalk and functional ecology within vaginal microbial communities to develop the microbial consortium STMC-105. This synergistic multi-strain LBP is designed to provide maximum resilience from vaginal microbiota community disruption, opportunistic pathobiont colonization, and recurrence of symptomatic bacterial vaginosis.
STMC-106 – Prevention of Necrotizing Enterocolitis (NEC)
Necrotizing enterocolitis is a serious inflammatory disease of the bowel and the most common single cause of sepsis and death in preterm infants. NEC occurs primarily in infants born before 32 weeks gestation, with overall incidence inversely proportional to gestational age. Several additional risk factors for NEC, including initiation of enteral feeding, antibiotic treatment, and acid suppression treatment, are key factors influencing the development of the preterm infant gut microbiome. Observations of abnormal infant gut microbiome development in preterm infants, with increased colonization by opportunistic pathobionts, strongly supports the role of the gut microbiome in the pathogenesis of NEC. Siolta Therapeutics is leveraging our proprietary Precision Symbiotic Platform to develop STMC-106, a mixed-species LBP designed to fortify the preterm infant gut by instilling protective microbe-epithelial signaling and metabolic activity that reduces pathobiont colonization and restores intestinal epithelial barrier function. STMC-106 will simultaneously leverage multiple mechanisms of action to reduce the development of NEC in high-risk preterm infants.
Siolta Expanded Access Policy
Siolta Therapeutics is dedicated to advancing our microbiome-based clinical development programs to potentially benefit as many patients as possible. To accomplish this objective, Siolta Therapeutics is currently conducting the well-controlled clinical trials necessary to evaluate safety and efficacy data in clinical trial subjects in support of potential regulatory approval.
Siolta Therapeutics does not offer an expanded access program for our investigational products prior to FDA approval. Expanded access, also called compassionate use, allows access to investigational products to patients with serious or immediately life-threatening diseases who do not meet the enrollment criteria for current clinical trials. This policy has been established as outlined in the 21st Century Cures Act. The expanded access policy may be revised based on data from ongoing and future clinical development.
Siolta Therapeutics recognizes that expanded access to potentially beneficial therapies outside of clinical trials may be valuable to patients with serious conditions, particularly in the absence of effective alternatives treatments. However, at this phase of clinical development, and until sufficient safety and efficacy data are collected, Siolta Therapeutics believes the best approach to characterize and understand the risks and benefits of its investigational products is through the controlled setting of clinical trials. We believe that executing our current and future clinical trials with the highest rigor is the optimal path forward to the regulatory approval that will allow us to ultimately reach the greatest number of patients.
Siolta Therapeutics strongly encourages patients to speak with their physicians about possible clinical trial participation. Reference information about our investigational products and the ongoing clinical trials can be found at https://www.sioltatherapeutics.com/ and https://clinicaltrials.gov. If you have additional questions please speak to your physician or contact us at firstname.lastname@example.org.