January 31, 2015 6:03 AM ET

Biotechnology

Company Overview of TransTech Pharma, LLC.

Company Overview

TransTech Pharma, LLC., a clinical stage pharmaceutical company, engages in the discovery, development, and commercialization of human therapeutics. The company engages in translating the functional modulation of human proteins into medicines. Its products include a pipeline of small molecule clinical and pre-clinical drug candidates for the treatment of a range of human diseases, including central nervous system disorders, cardiovascular disorders, type I/II diabetes, obesity, metabolic diseases, inflammatory diseases, female sexual dysfunction, primary open angle glaucoma, and cancer. The company’s products comprise TTP488, an orally bioavailable compound, which is developed as a treatment...

4170 Mendenhall Oaks Parkway

High Point, NC 27265

United States

Founded in 1998

Phone:

336-841-0300

Fax:

336-841-0310

Key Executives for TransTech Pharma, LLC.

President
Age: 57
Chief Scientific Officer and Senior Vice President
Senior Vice President of Chemistry
Senior Vice President of Clinical Research & Medical Affairs
Senior Vice President of Clinical Development
Compensation as of Fiscal Year 2014.

TransTech Pharma, LLC. Key Developments

TransTech Pharma, LLC Announces Agreement with FDA on Special Protocol Assessment for TTP488 Phase 3 Trial in Patients with Mild Alzheimer's Disease

TransTech Pharma, LLC announced that it has reached an agreement with the U.S. Food and Drug Administration Division of Neurology Products, under the Special Protocol Assessment (SPA) process, on the design of a single Phase 3 trial of TTP488 for the treatment of patients with mild Alzheimer's disease. A Special Protocol Assessment (SPA) from the FDA is a binding agreement that the Phase 3 trial design, planned execution and statistical analyses are acceptable to support regulatory approval. The Phase 3 trial will be a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of TTP488 for the treatment of patients with mild Alzheimer's disease. The trial will compare TTP488 5mg daily to placebo over the course of 18 months of treatment. Approximately 800 patients with mild Alzheimer's disease receiving standard of care (that is acetylcholinesterase inhibitors) will be enrolled. The primary efficacy analysis will be based on the changes in ADAS-cog (Alzheimer's Disease Assessment Scale -- cognitive subscale) and CDR-sb (Clinical Dementia Rating -- sum of boxes). TransTech Pharma anticipates beginning enrollment of patients before the end of 2014.

TransTech Pharma, LLC and High Point Pharmaceuticals, LLC Appoint Stephen L. Holcombe as President

TransTech Pharma, LLC (TransTech) announced that effective March 28, 2014, Stephen L. Holcombe, who previously served as the company's Senior Vice President and Chief Financial Officer, has been appointed to serve as the President of TransTech and its sister company High Point Pharmaceuticals, LLC (High Point). Mr. Holcombe will also continue his duties as Chief Financial Officer. Mr. Holcombe's appointment as the President of the companies follows the resignation by the founder Adnan M.M. Mjalli, Ph.D. from his role as President and Chief Executive Officer of TransTech and High Point effective March 28, 2014. Dr. Mjalli will continue to serve as a member of the Board of Directors of both companies as well as Chief Executive Officer of TransTech's affiliate, High Point Clinical Trials Center, LLC.

TransTech Pharma, Inc. Completes End of Phase 2 Meeting with FDA for TTP488

TransTech Pharma, Inc. announced that it has successfully completed an End of Phase 2 meeting for TTP488 with the U.S. Food and Drug Administration (FDA). TTP488 is under development for the treatment of mild to moderate Alzheimer's disease. The FDA Division of Neurology Products agreed that the data from the completed Phase 2 clinical trial is sufficient to support the start of a Phase 3 registration program. The FDA concurred with TransTech's proposal for the overall size and design of the planned Phase 3 clinical studies, the primary endpoints, the total safety database proposed for NDA filing, the clinical pharmacology program and the plan to apply for a Special Protocol Assessment. The Phase 3 clinical trial design for TTP488 will focus on patients with mild to moderate Alzheimer's disease. TransTech Pharma anticipates filing an SPA request within the next few weeks.

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