HMI-102, Emerging Drug Insight and Market Forecast – 2032

HMI-102, Emerging Drug Insight and Market Forecast – 2032

“HMI-102, Emerging Drug Insight and Market Forecast – 2032” report provides comprehensive insights about HMI-102 for Phenylketonuria (PKU) in the 7MM. A detailed picture of the HMI-102 for Phenylketonuria (PKU) in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2019–2032 is provided in this report along with a detailed description of the HMI-102 for Phenylketonuria (PKU). The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the HMI-102 market forecast, analysis for Phenylketonuria (PKU) in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Phenylketonuria (PKU).

Drug Summary

HMI-102 is being developed by Homology Medicines as an investigational gene therapy to treat phenylketonuria (PKU) in adults. The therapy is designed to encode the PAH gene, which is mutated in people with PKU, and is delivered via the liver-tropic AAVHSC15 vector. It consists of an AAVHSC15 vector containing the coding sequence of human PAH under the control of a promoter designed to express PAH continuously, specifically in the liver. The company chose AAVHSC15 as the basis of this product candidate because of its tropism for the liver, the normal site for PAH protein expression.

Homology is conducting the Phase II dose expansion portion of a randomized, concurrently controlled clinical trial (called the pheNIX study).

In February 2022, the US FDA notified the company that its pheNIX gene therapy trial of HMI-102 in adults with phenylketonuria (PKU) was placed on clinical hold due to the need to modify risk mitigation measures in the study in response to observations of elevated liver function tests. The company planned to provide an update pending further clarity from the FDA. However, there are no further updates.

Scope of the Report

The report provides insights into:

A comprehensive product overview including the HMI-102 description, mechanism of action, dosage and administration, research and development activities in Phenylketonuria (PKU).

Elaborated details on HMI-102 regulatory milestones and other development activities have been provided in this report.

The report also highlights the HMI-102 research and development activity in Phenylketonuria (PKU) in detail across the United States, Europe and Japan.

The report also covers the patents information with expiry timeline around HMI-102.

The report contains forecasted sales of HMI-102 for Phenylketonuria (PKU) till 2032.

Comprehensive coverage of the late-stage emerging therapies for Phenylketonuria (PKU).

The report also features the SWOT analysis with analyst views for HMI-102 in Phenylketonuria (PKU).

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

HMI-102 Analytical Perspective by DelveInsight

In-depth HMI-102 Market Assessment

This report provides a detailed market assessment of HMI-102 in Phenylketonuria (PKU) in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2025 to 2032.

HMI-102 Clinical Assessment

The report provides the clinical trials information of HMI-102 in Phenylketonuria (PKU) covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

In the coming years, the market scenario for Phenylketonuria (PKU) is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.

The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence HMI-102 dominance.

Other emerging products for Phenylketonuria (PKU) are expected to give tough market competition to HMI-102 and launch of late-stage emerging therapies in the near future will significantly impact the market.

A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of HMI-102 in Phenylketonuria (PKU).

Our in-depth analysis of the forecasted sales data of HMI-102 from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the HMI-102 in Phenylketonuria (PKU).

Key Questions

What is the product type, route of administration and mechanism of action of HMI-102?

What is the clinical trial status of the study related to HMI-102 in Phenylketonuria (PKU) and study completion date?

What are the key collaborations, mergers and acquisitions, licensing and other activities related to the HMI-102 development?

What are the key designations that have been granted to HMI-102 for Phenylketonuria (PKU)?

What is the forecasted market scenario of HMI-102 for Phenylketonuria (PKU)?

What are the forecasted sales of HMI-102 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?

What are the other emerging products available in Phenylketonuria (PKU) and how are they giving competition to HMI-102 for Phenylketonuria (PKU)?

Which are the late-stage emerging therapies under development for the treatment of Phenylketonuria (PKU)?