Pharma Focus Europe

IAMA Therapeutics and Evotec Establish Multi-phase, Strategic Provider Agreement

Tuesday, October 03, 2023

IAMA Therapeutics, a pharmaceutical company dedicated to developing innovative medicines for children affected by brain disorders, has recently announced a strategic collaboration with Evotec, a company specializing in integrated drug development solutions. This partnership aims to support IAMA in conducting a Phase 1 clinical trial for their lead program, IAMA-6, a small molecule therapeutic designed to target NKCC1 for the treatment of autism and epilepsy, with a particular focus on evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics.

This agreement builds upon the existing relationship between the two companies, which initially centered on preclinical studies to enable the submission of an Investigational New Drug (IND) application for IAMA-6. Under this expanded agreement, Evotec will assume responsibility for the execution and management of the Phase 1 clinical trial. This trial is planned to be a randomized, double-blind, placebo-controlled study involving the administration of single ascending doses (SAD) and multiple ascending doses (MAD) to healthy adult volunteers, both male and female. IAMA's objective is to submit a Clinical Trial Application (CTA) within the European Union and initiate the Phase 1 trial by the conclusion of 2023.

Andrea P. Malizia, Ph.D., MBA, the Chief Executive Officer of IAMA, expressed enthusiasm for the ongoing collaboration with Evotec. Malizia highlighted the joint efforts to offer a seamless range of services, including toxicity assessments, safety evaluations, manufacturing support, and other critical aspects of drug discovery and development. Additionally, they emphasized the significance of INDiGO, a regulatory support service, in facilitating their mission to develop effective treatments for pediatric neurological conditions. Malizia emphasized that this represents a pivotal moment for IAMA as they progress their lead program towards clinical trials.

Dr. Matthias Evers, Chief Business Officer of Evotec, expressed pride in their support for IAMA, underscoring Evotec's extensive suite of clinical-enabling services, including INDiGO, as they move closer to clinical studies. He conveyed anticipation for further enhancements to their partnership, emphasizing the efficiency and seamless integration of their services in advancing IAMA's mission.

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