Inhibitor Therapeutics Updates Clinical Development Plans
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Inhibitor Therapeutics Provides Clinical Development Update
Inhibitor Therapeutics, Inc. (OTCQB: INTI) has made strides in its efforts to advance its itraconazole formulation aimed at treating Basal Cell Carcinomas, particularly for patients diagnosed with Basal Cell Carcinoma Nevus Syndrome, also known as Gorlin Syndrome. The company is collaborating with The Gorlin Syndrome Alliance and has consulted with its knowledgeable Scientific Advisory Board to navigate a swift pathway toward approval from the U.S. Food and Drug Administration (FDA).
Regulatory Guidance and Milestones
Inhibitor has put forth a Pre-Investigational New Drug (PIND) application, which has garnered attention from the FDA’s Division of Dermatology and Dentistry, alongside insights from the Division of Oncology 3 where deemed necessary. Preliminary feedback from the FDA has been encouraging and is aiding Inhibitor in preparing for an Investigational New Drug Application (IND).
Engagement with Avior Bio
For the development of a new proprietary and potentially patentable itraconazole formulation, Inhibitor has selected Avior Bio for collaboration. This effort aims to bridge the new formulation with the one utilized in earlier clinical studies along with the generic itraconazole formulation by conducting a pharmacokinetic (PK) study. Notably, itraconazole is recognized for its well-established safety profile, and previous data showcases meaningful efficacy against Basal Cell Carcinomas in individuals with Gorlin Syndrome.
Clinical Study Outcomes
The clinical study examined 477 targeted tumors, revealing substantial results: 399 tumors experienced some degree of size reduction, with 275 tumors (57.7%) showing a clinically significant reduction of 30% or more. Additionally, 130 tumors (27.3%) completely resolved, highlighting the treatment's potential effectiveness.
Future Development Plans
Inhibitor’s strategy for ongoing development of its itraconazole formulation encompasses several key objectives. These include finalizing the new proprietary formulation and pursuing patent protection; conducting and compiling results from the bridging PK study; and preparing to submit the IND to the FDA. The company anticipates being ready to submit this IND by the close of the first quarter of the upcoming year.
Company Commitment and Contact Information
Inhibitor Therapeutics is dedicated to improving patient outcomes through innovative therapies. For more details about the company's mission and products, interested parties may refer to their website. Should there be any specific inquiries, individuals are encouraged to reach out through the provided contact page for assistance from the company's representatives.
Frequently Asked Questions
What is the focus of Inhibitor Therapeutics, Inc.?
Inhibitor Therapeutics focuses on developing treatments for Basal Cell Carcinomas, particularly in patients with Gorlin Syndrome.
What is the status of Inhibitor's itraconazole formulation?
The company's itraconazole formulation is progressing towards IND submission, with preliminary feedback from the FDA assisting in the process.
Who is Avior Bio?
Avior Bio is the partner engaged by Inhibitor Therapeutics for the development of a new patentable itraconazole formulation.
What were the results of the recent clinical study?
The study showed that 57.7% of the targeted tumors had a significant reduction in size, with 27.3% completely resolving.
How can I learn more about Inhibitor Therapeutics?
For more information, individuals can visit Inhibitor's website or contact their team directly through the contact page.
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