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Details:
The proceeds are expected to be allocated mainly to the development of ABX464 (obefazimod), an oral, first-in-class, small molecule, for the treatment of adults with moderately to severely active UC and other potential chronic inflammatory indications.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kreos Capital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing August 21, 2023
Details:
ABX464 (Obefazimod), is a highly differentiated oral drug candidate, with a novel mechanism of action based on the upregulation of a single microRNA (miR-124) with potent anti-inflammatory properties.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 17, 2023
Details:
The Company plans to use the net proceeds for the launch and continuation of the clinical programs of ABX464 (obefazimod), the Company's lead drug candidate in clinical development for ulcerative colitis.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: TCGX
Deal Size: $137.7 million Upfront Cash: Undisclosed
Deal Type: Financing February 22, 2023
Details:
ABX464 (Obefazimod), is a highly differentiated oral drug candidate, with a novel mechanism of action based on the upregulation of a single microRNA (miR-124) with potent anti-inflammatory properties.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2023
Details:
ABX464 (Obefazimod), is a highly differentiated oral drug candidate, with a novel mechanism of action based on the upregulation of a single microRNA (miR-124) with potent anti-inflammatory properties.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2023
Details:
The ABTECT program aims to confirm obefazimod’s potential to maintain and further improve patient-outcomes over time, as well as its safety and tolerability profile, as already observed during previously conducted Phase 2a and Phase 2b clinical trials in moderate to severe UC.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
In consultation with international regulators, including both FDA and EMA, obefazimod 25mg and 50mg will be investigated in ABTECT program for treatment of UC in advanced therapies (AT) naive and in AT-failure patients to support future submission of marketing authorizations.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2022
Details:
ABX464 (obefazimod) is a small molecule that selectively upregulates miR-124 in immune cells. We aimed to assess ABX464 as a treatment for patients with moderate-to-severe, active ulcerative colitis.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
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 September 05, 2022
Details:
The planned use of the net proceeds of the Transaction is, based on the Company’s current plans, follows the launch and continuation of the clinical programs of obefazimod (ABX464), the Company’s lead product in advanced development.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: TCGX
Deal Size: $49.2 million Upfront Cash: Undisclosed
Deal Type: Financing September 02, 2022
Details:
ABX464 (obefazimod) is an oral, first-in-class, small molecule that has demonstrated safety and profound anti-inflammatory activity in preclinical trials and in Phase 2a and Phase 2b induction trials to treat ulcerative colitis (UC).
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
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 04, 2022
Details:
ABX464 is an oral, first-in-class, small molecule that has demonstrated safety and profound anti-inflammatory against ulcerative colitis and COVID-19.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
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 18, 2021
Details:
In the study, 254 patients with moderate-to-severe UC received treatment with ABX464, with topline data showing significant clinical efficacy in the overall population on both primary and key secondary endpoints.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
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 24, 2021
Details:
The randomized, double-blind and placebo-controlled phase 2b induction trial had four arms: three once-daily oral ABX464 treatment groups (25 mg, 50 mg and 100 mg) and one placebo group.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
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 14, 2021
Details:
Peer-reviewed article confirms the quality and robustness of clinical data and the good safety and durable efficacy of once daily oral ABX464 in moderate to severe ulcerative colitis (UC) patients.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
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 03, 2021
Details:
Scientific data underpins ABX464’s potential to treat the root cause of inflammation explaining its efficacious induction and maintenance of clinical remission in Phase 2a ulcerative colitis clinical studies.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
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 January 05, 2021
Details:
ABX464 has shown in clinical and preclinical studies that it may have a potentially beneficial triple effect for the treatment of elderly and high-risk Covid-19 patients, including an antiviral and anti-inflammatory effect as well as tissue repair properties.
Lead Product(s): Obefazimod
Therapeutic Area: Infections and Infectious Diseases Product Name: ABX464
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2020
Details:
To further support the clinical dossier from the fully enrolled ABX464 phase 2b trial in UC, with results expected in Q2 2021, three phase 1 studies in healthy volunteers are being initiated which are part of usual practice during late-stage clinical development.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
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 December 09, 2020
Details:
Phase 2a open label maintenance results after second year of treatment confirm good safety profile and durable efficacy of 50mg once-daily oral ABX464.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology Product Name: ABX464
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 September 02, 2020
Details:
The randomized, double-blind, placebo-controlled miR-AGE study aims to measure the potential of ABX464 to limit viral replication as well as the severe inflammation that leads to acute respiratory distress syndrome (ARDS).
Lead Product(s): Obefazimod
Therapeutic Area: Infections and Infectious Diseases Product Name: ABX464
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 02, 2020
Details:
The randomized, double-blind, placebo-controlled study is investigating early treatment (at diagnosis) in 1,034 COVID-19 elderly or high-risk patients (miR-AGE trial).
Lead Product(s): Obefazimod
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2020
Details:
Active U.S. Investigational New Drug (IND) status extends Phase 2b clinical study in moderate to severe Ulcerative Colitis (UC) clinical trial to U.S. patients.
Lead Product(s): Obefazimod
Therapeutic Area: Gastroenterology 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 January 20, 2020
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