Accutar Biotech has terminated the clinical trials of AC176, an AR PROTAC therapy, for the treatment of prostate cancer. These decisions came after the termination of a clinical trial of AC682, an ER PROTAC treatment in the phase 1 stage.
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| Homepage of Accutar |
The clinical trials
AC176 is an AR-targeting PROTAC drug candidate discovered by Accutar Biotech. The IND application was cleared by both the China NMPA and the US FDA.
The clinical trial (NCT05673109/CTR20223355) was started in China, with the first patient receiving the dose in February 2023. Currently, the study has enrolled eight patients as reported on the clinical trial disclosure website. However, the trial was terminated due to changes in the benefit-risk ratio for the subjects at the end of 2023. No further statements were reported regarding this matter.
The phase 1 trial (NCT05241613) in the US has enrolled 28 patients and has been terminated for the same reason as above. The trial stopped enrolling new patients in October 2023 and was terminated in March 2024.
Accutar pipeline updates
Accutar currently has four PROTAC candidates in its pipeline, which includes AR, ER, and BTK targets. AC676, which targets BTK, and AC699 which targets ER are still recruiting patients.
AC682 is the second ER targeting product, following AC699. However, the trial was terminated in January 2024. Besides Accutar, Hengrui has initiated the phase 1 study of its ER PROTAC HRS-1358. It is worth noting that some of the ER PROTAC candidates, such as Hinova, are still in the preclinical stage.
#Accutar Biotech Has Terminated the Trial of #AC682 (AC0682) in ER-Positive Breast Cancer #PROTAC #AC699https://t.co/n8P0HkSAsD
— CBX (@CNBioXYZ) January 19, 2024
The competitive landscape of AR PROTAC differs from that of ER PROTAC in China. The termination of AC176 left some potential market for the below companies.
|
Product |
Company |
MoA |
Stage |
Indication |
Enrollment |
Initiation |
|
HP518 |
Hinova |
AR |
Phase 1 |
mCRPC |
62 |
2023.11 |
|
HRS-5041 |
Hengrui |
AR |
Phase 1 |
mCRPC |
100 |
2023.07 |
|
GT20029 |
Kintor |
AR |
Phase 2 |
Acne vulgaris |
165 |
2024.03 |
|
Phase 2 |
Androgenetic Alopecia |
180 |
2023.03 |
|||
|
Phase 1 |
Acne/Alopecia |
92 |
2021.06 |
|||
|
HC-X029 |
Hinova |
AR-sv |
Preclinical |
mCRPC |
- |
- |
In 2021, the CEO said, "The IND clearance for AC0176 is another important validation, after our AC0682 entered the clinic recently, that our AI platform can support and advance the discovery of potentially differentiated clinical candidates quickly, especially complex compounds such as chimeric degrades." This statement was made after the IND clearance of AC176.
Concerns were raised about the AI platform after terminating AC682 and AC176. We'll closely monitor AC699 and AC676.
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