The agreement expands the companies' existing relationship, which entails collaborating on IND-enabling preclinical studies for IAMA-6

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IAMA is developing IAMA-6 for potentially treating drug-resistant epilepsies and rare syndromic forms of autism. (Credit: valelopardo from Pixabay)

IAMA Therapeutics, a pharmaceutical company focused on the discovery, development, and commercialization of novel medicines for children affected by brain disorders, today announced that it has signed a multi-phase agreement with Evotec, which offers integrated drug development solutions. Evotec will provide IAMA with preclinical and clinical services to support the anticipated Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD), and multiple ascending doses (MAD) clinical trial to investigate the safety, tolerability, PK and PD of IAMA’s lead program IAMA-6, a small molecule therapeutic targeting NKCC1 for the treatment of autism and epilepsy.

The agreement expands the companies’ existing relationship, which entails collaborating on IND-enabling preclinical studies for IAMA-6. Under the agreement, Evotec will be responsible for conducting, executing, and managing the randomized, double-blind, placebo-controlled phase 1 Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IAMA-6 administered orally to male and female healthy adult volunteers. IAMA plans to submit a CTA filing in the EU and initiate a Phase 1 clinical trial by the end of 2023.

“We are excited to continue our collaboration with Evotec, our partner, to provide seamlessly integrated toxicity, safety, manufacturing, and other discovery and development services, including INDiGO, to support our regulatory studies,” said Andrea P. Malizia, Ph.D., MBA Chief Executive Officer. “This is an exciting inflection point for IAMA as we advance our lead program into the clinic to fulfill our mission to develop clinically meaningful treatments for pediatric neurological conditions.”

“We are proud to support IAMA with Evotec’s full stack of clinical-enabling services, including INDiGO, as their lead program progresses towards clinical studies,” said Dr. Matthias Evers, Chief Business Officer of Evotec. “We look forward to adding further rapid, efficient, and seamlessly integrated services to build on our successful relationship with IAMA.”

Source: Company Press Release