Our lead compound is a highly selective dual TYK2/JAK1 inhibitor for inflammatory and autoimmune diseases. It has unparalleled selectivity with respect to JAK2, JAK3 and other kinases. Its high selectivity may give rise to better safety than other less or non-selective JAK inhibitors. Furthermore, the dual inhibition of TYK2 and JAK1 might lead to better efficacy than either TYK2 or JAK1 inhibitors in some inflammatory and autoimmune diseases.
TLL-018 is currently in a Phase 2 trial in subjects with moderate to severe ulcerative colitis. See the link below for more information.
https://clinicaltrials.gov/ct2/show/NCT05121402?term=TLL-018&draw=2&rank=1
Our policy on responding to requests to provide access to our investigational therapies to patients is outlined below.
Expanded access is defined as use of an investigational therapy outside of a clinical trial. A clinical trial is an approved research study conducted by trained physicians where comprehensive safety and efficacy data are collected on an investigational therapy to determine the therapy’s risk/benefit profile for patients. Highlightll (USA) Pharma encourages patient participation in our clinical trials. Please refer to clinicaltrials.gov to access our investigational therapies.
Rarely, physicians may identify patients with serious diseases or conditions who cannot participate in our clinical trials but who might benefit from access to an unapproved Highlightll (USA) Pharma product.
Consistent with the US Food and Drug Administration (US FDA) and other regulatory agencies’ guidelines, Highlightll (USA) Pharma considers the following with regards to patient access to investigational therapy being developed by Highlightll (USA) Pharma. They include:
· The patient’s illness must be serious or life-threatening with no other alternate treatment options for the patient (including approved therapies or enrolling in a clinical trial)
· Sufficient scientific/medical evidence must exist to support the potential benefit to the patient would likely outweigh the potential risks, based on available safety and efficacy data. Generally, safety information to support expanded access would be obtained from a completed Phase I study.
· Highlightll (USA) Pharma must have the capacity to provide the product fairly and equitably, ensuring adequate manufacturing capacity for ongoing clinical trials.
· Expanded access programs cannot compromise the scientific validity of ongoing Highlightll (USA) Pharma clinical development, interfere with or delay current or anticipated clinical studies or regulatory submissions due to Highlightll (USA) Pharma’s mission to provide approved therapies to as many patients as possible as soon as possible.
· Highlightll (USA) Pharma shall limit expanded access to countries where expanded access is permitted by local authorities and Highlightll (USA) Pharma has dequate resources including but not limited to safety monitoring to comply with all local regulatory requirements.
A qualified treating physician for any expanded access request must be identified and the physician must agree to comply with all applicable Highlightll (USA) Pharma and local regulatory requirements, including safety reporting, adverse event collection and long-term follow-up consistent with local health authority requirements.
Highlightll (USA) Pharma encourages patient participation in our investigational therapies. For additional questions, speak with your physician or contact <patients@highlightllpharma.com>. Highlightll (USA) Pharma will acknowledge receipt of emails sent to this address within five business days. Highlightll (USA) Pharma shall review all requests according to Highlightll (USA) Pharma procedures and notify the requestor of the determination.
