Clinical trials are now underway
At Siolta Therapeutics, we are leveraging our knowledge of the developing infant gut microbiome and its role in promoting immune tolerance to develop targeted human microbiome therapeutics for the prevention and treatment of chronic inflammatory diseases, starting with allergic disease. Our exciting and novel approach, which includes prevention, is designed to address serious conditions and fill an unmet need, and as such has been granted Fast Track status by the U.S. Food & Drug Administration (FDA).
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-102, 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.
In addition to prevention, Siolta is investigating STMC-103H for it’s effectiveness in treating established allergic diseases, including atopic dermatitis, food allergy, and allergic asthma.
Siolta is utilizing it’s platform technology to develop additional live biotherapeutic products (LBPs) in order to address chronic diseases beyond allergy and asthma, particularly those with a clear microbial influence that impact children’s health and long term well-being.
Microbiome-based diagnostics will support our pursuit of precision medicine.
In addition to microbial therapeutics, we are employing the comprehensive data collected in our clinical studies to develop companion diagnostics and biomarker assays that can help clinicians identify those patients who will benefit most from intervention with our live biotherapeutic products.
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 on 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.