Melodia buys rights to potential AAV therapy MDI-0151

Company will ‘rapidly initiate’ steps toward clinical trials

Patricia Inacio, PhD avatar

by Patricia Inacio, PhD |

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Melodia Therapeutics has acquired the exclusive rights to develop, manufacture, and commercialize MDI-0151, a candidate therapy for hard-to-treat ANCA-associated vasculitis (AAV) and other disorders marked by overactivation of neutrophils, a type of immune cell.

Melodia said it will “rapidly initiate” investigational new drug (IND)-enabling studies in preparation of a Phase 1/Phase 2a clinical trial of MDI-0151 in AAV and other neutrophil-related inflammatory disorders. IND-enabling studies concern preclinical research intended to support regulatory clearance to test a therapy in clinical trials.

Under the terms of the agreement, Alivexis, the therapy’s developer, will receive up to about $275 million from Melodia as an upfront payment, in addition to development and sales milestone payments. Alivexis also will be eligible to receive royalties according to net revenues, as well as warrants for Melodia’s common shares.

The agreement “marks a significant milestone for Alivexis and serves as validation of our drug discovery R&D team and platform, our proprietary pipeline of discovery programs, and our business model involving the use of our cutting-edge platform to accelerate clinical candidate discovery for diseases with high unmet need,” Roy Kimura, PhD, CEO of Alivexis, said in a joint company press release.

“We are confident that the Melodia team will be able to take our candidate molecule through clinical trials and ultimately help many patients in need suffering from chronic inflammatory diseases,” Kimura said.

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‘Blockbuster potential’

AAV occurs when self-reactive antibodies, called ANCAs, glom onto neutrophils, overactivating them and priming them against small blood vessels, causing inflammation and damage. This causes symptoms affecting the kidneys and other organs.

Despite the availability of some approved therapies for AAV, some patients still don’t respond to treatment or relapse after a time.

MDI-0151, developed as part of Alivexis’ discovery program MOD-A, is a suppressor of cathepsin C. This enzyme, also known as dipeptidyl peptidase-1, activates neutrophil-derived enzymes that promote tissue damage.

Blocking cathepsin C is believed to have no major effect on neutrophils’ immune surveillance activity. MDI-0151, therefore, has the potential to be a promising therapy for hard-to-treat AAV and other inflammatory conditions associated with neutrophil overactivation, while not impairing the immune system.

“We consider that this asset from Alivexis has best-in-class, blockbuster potential,” said Forty51 Ventures, Melodia’s founding shareholder. “Melodia aims to develop the program in a variety of underserved indications in the field of immunology. Further announcements will follow shortly as Melodia advances this program expeditiously.”