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Details:
The Phase II trial is a randomized, double-blind, placebo-controlled, multicenter clinical trial to be conducted in China to evaluate the safety and efficacy of ASC40 for the treatment of patients with moderate to severe acne vulgaris.
Lead Product(s): Tvb-2640
Therapeutic Area: Dermatology Product Name: ASC40
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 09, 2021
Details:
The data from the Phase II trial have shown that the overall response rate (ORR) for ASC40 (TVB-2640) plus Bevacizumab was 65% including a complete response (CR) of 20% and a partial response (PR) of 45%.
Lead Product(s): Tvb-2640,Bevacizumab
Therapeutic Area: Oncology Product Name: TVB-2640
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2021
Details:
The data from the Phase II trial have shown that the overall response rate (ORR) for ASC40 (TVB-2640) plus Bevacizumab was 65% including a complete response (CR) of 20% and a partial response (PR) of 45%.
Lead Product(s): Tvb-2640,Bevacizumab
Therapeutic Area: Oncology Product Name: ASC40
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2021
Details:
The positive results were demonstrated from the investigator sponsored Phase II trial of ASC40 (TVB-2640) in combination with bevacizumab in patients with first relapse of high-grade astrocytoma i.e. rGBM, which was completed in the United States.
Lead Product(s): Tvb-2640,Bevacizumab
Therapeutic Area: Oncology Product Name: ASC40
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2021
Details:
Sagimet will present results from an ongoing Phase 2 clinical trial of TVB-2640 in NASH patients in the poster entitled "Analysis of non-invasive biomarker tests in the Phase 2 FASCINATE-1 Study of FASN Inhibitor TVB-2640.
Lead Product(s): Tvb-2640
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: TVB-2640
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2021
Details:
The preliminary data showed that ASC40 meaningfully reduced liver fat, the primary efficacy endpoint of this trial, with a 50% responder rate (patients achieving ≥30% reduction).
Lead Product(s): Tvb-2640
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC40
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2021
Details:
Funds raised will support the advancement of TVB-2640, an oral, first-in-class fatty acid synthase (FASN) inhibitor, including a planned Phase 2b trial evaluating the impact on histological endpoints.
Lead Product(s): Tvb-2640
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC40
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ascletis Pharma
Deal Size: $80.0 million Upfront Cash: Undisclosed
Deal Type: Financing February 11, 2021
Details:
The preliminary data showed that ASC40 (TVB-2640) significantly reduced liver fat, the primary efficacy endpoint of this trial, with a 61% responder rate in the 50 mg group. Participants also showed improvement in markers of liver function and fibrosis.
Lead Product(s): Tvb-2640
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC40
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sagimet Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
In this randomized, placebo-controlled trial, a novel, first-in-class, FASN inhibitor, TVB-2640 significantly decreased liver fat and serum biomarkers of liver injury, fibrosis and inflammation with an excellent safety profile and tolerability.
Lead Product(s): Tvb-2640
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC40
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
Details:
This bridging study in China demonstrated linear pharmacokinetic for ASC40 (TVB-2640) from oral, single doses of 25, 50 to 75 mg. ASC40 is safe and well-tolerated in Chinese subjects and majority of adverse events are grade1.
Lead Product(s): Tvb-2640
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: ASC40
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2020
Details:
The preliminary data showed that ASC40 (TVB-2640) significantly reduced liver fat, the primary efficacy endpoint of this trial, with a 61% responder rate in the 50 mg group. Participants also showed improvement in markers of liver function and fibrosis.
Lead Product(s): Tvb-2640
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: TVB-2640
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2020
Details:
TVB-2640 versus placebo demonstrated clinically significant reduction in liver fat by MRI-PDFF in NASH: A phase 2 randomized controlled trial (FASCINATE-1).
Lead Product(s): Tvb-2640
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2020
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