synb1618 emerging drug insight and market forecast

“SYNB1618, Market Size, Forecast, and Emerging Insight – 2032” report provides comprehensive insights about SYNB1618 for Phenylketonuria (PKU) in the 7MM. A detailed picture of the SYNB1618 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 SYNB1618 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 SYNB1618 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

SYNB1618 is an oral investigational synthetic biotic medicine designed to break down Phe in the GI tract, potentially reducing plasma Phe levels or allowing patients to consume higher amounts of natural protein, improving their quality of life. To date, the company has determined that SYNB1618 can effectively break down phenylalanine in the GI tract of both healthy volunteers and patients. Synlogic has now initiated a Phase II study in PKU patients called SynPheny-1 to see if SYNB1618 can decrease Phe levels in the blood.

TCA and HA are specific quantitative biomarkers of SYNB1618 activity, as demonstrated by preclinical data published in Nature Biotechnology by Synlogic and data from healthy volunteers from the first part of this Phase I/IIa study.SYNB1618 is also designed to metabolize Phe to Phenylpyruvate (PP) via a second enzyme mechanism, L-amino acid transaminase (LAAD). One of the downstream metabolites of LAAD activity is phenyl-lactic acid (PLA), which can be measured in the urine.

In November 2021, the company presented interim data from the Phase II SynPheny-1 trial featured in a late-breaking oral presentation during the 14th International Congress of Inborn Errors of Metabolism meeting. Further, Synlogic has added an additional arm to the ongoing Phase II Synpheny-1 trial to include a cohort of PKU patients treated with SYNB1934.

In addition, SYNB1934, an optimized strain of SYNB1618, further demonstrated a two-fold increase in biomarkers of Phe metabolism compared to SYNB1618 in a head-to-head healthy volunteer study. The Phase II SynPheny-1 study has been amended to incorporate SYNB1934, with results expected in the first half of 2022. In addition to this, Synlogic is preparing to start a Phase III program with the preferred strain based on the SynPheny-1 study data in Phenylketonuria (PKU) in 2022.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the SYNB1618 description, mechanism of action, dosage and administration, research and development activities in Phenylketonuria (PKU).
• Elaborated details on SYNB1618 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the SYNB1618 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 SYNB1618.
• The report contains forecasted sales of SYNB1618 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 SYNB1618 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.

SYNB1618 Analytical Perspective by DelveInsight

• In-depth SYNB1618 Market Assessment

This report provides a detailed market assessment of SYNB1618 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.

• SYNB1618 Clinical Assessment

The report provides the clinical trials information of SYNB1618 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 SYNB1618 dominance.
• Other emerging products for Phenylketonuria (PKU) are expected to give tough market competition to SYNB1618 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 SYNB1618 in Phenylketonuria (PKU).
• Our in-depth analysis of the forecasted sales data of SYNB1618 from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the SYNB1618 in Phenylketonuria (PKU).

Key Questions

• What is the product type, route of administration and mechanism of action of SYNB1618?
• What is the clinical trial status of the study related to SYNB1618 in Phenylketonuria (PKU) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the SYNB1618 development?
• What are the key designations that have been granted to SYNB1618 for Phenylketonuria (PKU)?
• What is the forecasted market scenario of SYNB1618 for Phenylketonuria (PKU)?
• What are the forecasted sales of SYNB1618 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 SYNB1618 for Phenylketonuria (PKU)?
• Which are the late-stage emerging therapies under development for the treatment of Phenylketonuria (PKU)?