Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) today announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted CRN04777 an "Innovation Passport" for the treatment of congenital hyperinsulinism (HI), which enables Crinetics to access the Innovative Licensing and Access Pathway (ILAP). The ILAP was launched in the United Kingdom in 2021 with the goal of reducing the time to market for innovative medicines that treat life-threatening or seriously debilitating conditions and/or conditions for which there is a significant unmet patient need. The ILAP aims to achieve this goal by enabling enhanced coordination between sponsors and MHRA leading up to Marketing Authorization Application (MAA) submissions and by providing the opportunity for accelerated MAA reviews.

"Congenital HI is a rare, life-threatening condition afflicting infants and young children that can lead to complications such as seizures, coma, and brain damage. Many children with the disease require intensive 24-hour glucose management, which is extremely burdensome and of limited efficacy," stated Scott Struthers, Ph.D., Crinetics' president and CEO. "We believe the Innovation Passport provides important external validation for the CRN04777 program and shows that the MHRA recognizes the struggle congenital HI patients and caregivers face each day. We are pleased to gain access to an expedited review pathway in the UK and look forward to developing CRN04777 as a potential effective oral therapy with the prospect to avoid many of the side effects and burdens associated with current treatments."

About the MHRA Innovation Passport
The MHRA Innovation Passport is the entry point to the ILAP, which aims to accelerate time to market, facilitating patient access to new medicines including new chemical entities, biological medicines, new indications and repurposed medicines. An ILAP designation is linked to a portfolio of activities through the product specific creation of a Target Development Profile (TDP). The TDP will define key regulatory and development features, identify potential pitfalls and create a road map for delivering early patient access to designated product candidates. The TDP will include details about how sponsors can work with other UK stakeholders for coordinated and efficient evidence generation and evaluation and address commercial and managed access considerations. More information on TDPs and the ILAP is available on the UK government website.