Mezzion Receives Encouraging Pre-IND Feedback from FDA on Udenafil for ADPKD

Mezzion Reports on Pre-IND FDA Feedback for Udenafil

In a significant step forward for Mezzion Pharma Co., Ltd., the company has announced the receipt of written feedback from the U.S. Food and Drug Administration (FDA) concerning their investigational drug, udenafil, which is being developed for the treatment of autosomal dominant polycystic kidney disease (ADPKD). This communication follows a pre-Investigational New Drug (IND) Type C Guidance meeting, where the FDA evaluated Mezzion's plans and data related to their drug.

The FDA has noted that the nonclinical data submitted by Mezzion, combined with prior clinical and safety experiences with udenafil, suggests a solid basis for progressing toward clinical studies. This indication from the FDA marks a positive endorsement of Mezzion’s scientific rationale and development strategy in addressing ADPKD, a severe genetic disorder characterized by kidney cysts leading to kidney failure and significant unmet medical needs.

To date, udenafil has been involved in multiple clinical trials in other therapeutic areas, establishing a robust dataset over several years of patient exposure. Building on this extensive history, Mezzion is now poised to further expand its research, aiming to initiate Phase 2 clinical trials in the near future, followed by Phase 3 evaluations for ADPKD.

Dean Park, Chairman and CEO of Mezzion, expressed optimism about the results of the FDA's review. He stated, “We are encouraged by the FDA's feedback, which we feel supports our scientific rationale and stated development approach for udenafil in ADPKD. We hope that our existing clinical dataset may enable a more efficient path into potential clinical studies.” This sentiment underscores Mezzion’s commitment to using its data to expedite the path toward new treatment options for patients.

ADPKD poses a considerable challenge due to the current lack of effective treatment solutions. Mezzion Pharma is confident that the unique mechanism of action offered by udenafil, along with its previous clinical data, may hold promise for evaluating it as an investigational therapy specifically aimed at ADPKD. The company sees this pre-IND interaction as a vital step in advancing their therapeutic approach and broadening the treatment landscape for individuals affected by this progressive disease.

Mezzion Pharma Co., Ltd., headquartered in South Korea and publicly traded on the KOSDAQ (140410), focuses on developing innovative therapies for rare and underserved medical conditions. Apart from ADPKD, Mezzion is also exploring potential applications of udenafil in other areas, notably in patients with Fontan physiology.

As Mezzion continues to navigate the regulatory landscape and prepare for the next phases of its clinical program, the company remains dedicated to ensuring that effective options are available for patients suffering from chronic conditions like ADPKD, which have historically had limited therapeutic options.

For further inquiries, media representatives can reach out to John Presser, Executive Vice President and Chief Business Officer, or Mr. Sung-Il Noh, Chief Financial Officer, through the contacts provided by the company.