- Maze Therapeutics completed its Phase I healthy volunteer study for **MZE-782**, demonstrating an **excellent safety profile**, linear pharmacokinetics, and robust pharmacodynamics, including up to a **42-fold increase in urinary phenylalanine** and a **68-fold increase in urinary glutamine**.  **[1842295_2138397_2]** **[1842295_2138397_3]** **[1842295_2138397_4]** **[1842295_2138397_5]** 
- Based on these positive results, Maze Therapeutics plans to initiate Phase II proof-of-concept studies for **MZE-782** in both Phenylketonuria (PKU) and Chronic Kidney Disease (CKD) in **2026**.  **[1842295_2138397_1]** **[1842295_2138397_2]** **[1842295_2138397_5]** 
- The company also reported that its Phase II trial for **MZE-829** is continuing to enroll, with initial top-line data anticipated in **Q1 2026**.  **[1842295_2138397_1]** 
- Financially, Maze Therapeutics licensed **MZE-001** for Pompe disease to Shionogi & Co. in **May 2024**, receiving an **upfront payment of $150 million** and securing an expected financial runway into **2028**.  **[1842295_2138397_1]**

Maze Therapeutics Announces Positive MZE-782 Phase I Results and Phase II Plans

- Maze Therapeutics announced **positive Phase I results** for MZE-782, demonstrating an **excellent safety profile** with no serious adverse events, predictable pharmacokinetics (PK), and robust pharmacodynamics (PD) with up to a **42-fold increase in urinary phenylalanine** and **68-fold increase in urinary glutamine** by day seven.  **[1842295_2138490_2]** **[1842295_2138490_3]** **[1842295_2138490_5]** 
- Based on these results, Maze plans to **initiate Phase II trials** for MZE-782 in both **PKU and CKD in 2026**.  **[1842295_2138490_1]** **[1842295_2138490_2]** **[1842295_2138490_6]** 
- The company's financial runway is expected to extend into **2028** based on its current business plan, and it previously licensed MZE-001 for Pompe disease to Shionogi & Co. in May 2024 for an **upfront payment of $150 million**.  **[1842295_2138490_1]** 
- Enrollment for the Phase II trial of MZE-829, a dual mechanism inhibitor for APOL1-mediated kidney disease, is continuing, with **initial top-line data expected in Q1 2026**.  **[1842295_2138490_1]**

Maze Therapeutics Announces Positive MZE-782 Phase I Results and Advancement to Phase II

- Maze Therapeutics announced **positive Phase 1 results** for its oral SLC6A19 inhibitor, **MZE782**, for Phenylketonuria (PKU) and Chronic Kidney Disease (CKD) on **September 11, 2025**.  **[1842295_2138320:0]** **[1842295_2138320:7]** 
- The study demonstrated an **excellent safety profile** with no serious adverse events and showed significant increases in urinary Phe (up to **42-fold**) and Gln (up to **68-fold**) at Day 7.  **[1842295_2138320:7]** **[1842295_2138320:18]** 
- These results support the **advancement of MZE782 into Phase 2 trials** for both PKU and CKD, with initiation planned for **2026**.  **[1842295_2138320:7]** **[1842295_2138320:19]** 
- The company also reported a **strong cash position** with an expected runway into **2028**.  **[1842295_2138320:5]**

Maze Therapeutics announces MZE782 Phase 1 results

- The **Phase I healthy volunteer study for MZE782 is complete**, demonstrating an **excellent safety profile**, predictable pharmacokinetics (PK), and robust on-mechanism pharmacodynamics (PD), including up to a **42-fold increase in urinary phenylalanine**.  **[1842295_2138640_2]** **[1842295_2138640_5]** 
- The study also showed an initial **dose-dependent eGFR dip**, consistent with renoprotective drugs, supporting potential kidney benefit in CKD.  **[1842295_2138640_2]** **[1842295_2138640_5]** 
- Maze Therapeutics plans to initiate **Phase II trials for MZE782 in both PKU and CKD in 2026**.  **[1842295_2138640_1]** **[1842295_2138640_6]** 
- The company licensed **MZE001 for Pompe disease to Shionogi in May 2024**, providing an **upfront payment of $150 million** and potential future milestone payments and royalties.  **[1842295_2138640_1]** 
- With recent financing, Maze expects its cash runway to extend into **2028**.  **[1842295_2138640_1]**

Maze Therapeutics Announces Positive MZE782 Phase I Results and Future Plans

- Maze Therapeutics announced an **oversubscribed private placement** for **gross proceeds of approximately $150.0 million**.  **[1842295_0001193125-25-200760_d90404dex991.htm:0]** **[1842295_0001193125-25-200760_d90404d8k.htm:1]** 
- The private placement includes participation from **new and existing investors**, including Frazier Life Sciences, Deep Track Capital, and Janus Henderson Investors.  **[1842295_0001193125-25-200760_d90404dex991.htm:0]** 
- The company will issue **4,000,002 shares of common stock** at **$16.25 per share** and **5,231,090 pre-funded warrants** at **$16.249 per pre-funded warrant**.  **[1842295_0001193125-25-200760_d90404dex991.htm:0]** **[1842295_0001193125-25-200760_d90404d8k.htm:1]** 
- The private placement is expected to close on **September 12, 2025**.  **[1842295_0001193125-25-200760_d90404dex991.htm:0]** **[1842295_0001193125-25-200760_d90404d8k.htm:1]** 
- Proceeds will be used to **advance the development of MZE829**, **initiate Phase 2 clinical trials of MZE782** in phenylketonuria (PKU) and chronic kidney disease (CKD), continue research and discovery programs, further the Compass platform, and for general corporate purposes.  **[1842295_0001193125-25-200760_d90404dex991.htm:0]** **[1842295_0001193125-25-200760_d90404d8k.htm:1]**

Maze Therapeutics (MAZE)