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InDex Pharmaceuticals
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Kappaproct (cobitolimod) is a Toll-like receptor 9 (TLR9) agonist, that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis.


Lead Product(s): Cobitolimod

Therapeutic Area: Gastroenterology Product Name: Kappaproct

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 21, 2023

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Kappaproct (cobitolimod) is a Toll-like receptor 9 (TLR9) agonist, that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis.


Lead Product(s): Cobitolimod

Therapeutic Area: Gastroenterology Product Name: Kappaproct

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 11, 2023

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Under the agreement, Viatris will register and commercialize Kappaproct (cobitolimod), a TLR9 agonist being evaluated in phase III as a novel treatment for moderate to severe ulcerative colitis, in Japan.


Lead Product(s): Cobitolimod

Therapeutic Area: Gastroenterology Product Name: Kappaproct

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Viatris

Deal Size: $50 million Upfront Cash: $10 million

Deal Type: Licensing Agreement May 31, 2023

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Details:

Kappaproct (cobitolimod) is a Toll-like receptor 9 (TLR9) agonist, that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis.


Lead Product(s): Cobitolimod

Therapeutic Area: Gastroenterology Product Name: Kappaproct

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 15, 2023

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Details:

Kappaproct (cobitolimod) is a Toll-like receptor 9 (TLR9) agonist, that can provide an anti‐inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis.


Lead Product(s): Cobitolimod

Therapeutic Area: Gastroenterology Product Name: Kappaproct

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 14, 2023

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Patients responding to Kappaproct (cobitolimod) in the induction study will be eligible to continue in a one-year maintenance study, where they will be treated with either cobitolimod or placebo once every three weeks.


Lead Product(s): Cobitolimod

Therapeutic Area: Gastroenterology Product Name: Kappaproct

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 27, 2023

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The phase III program for Kappaproct (cobitolimod) in moderate to severe left-sided ulcerative colitis consists of two sequential global induction studies and a year long maintenance study, with patients that have responded to cobitolimod as induction therapy.


Lead Product(s): Cobitolimod

Therapeutic Area: Gastroenterology Product Name: Kappaproct

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 16, 2022

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Details:

Kappaproct (Cobitolimod) is a topically administered, DNA-based oligonucleotide that activates Toll-like receptor 9 (TLR9), and previous research has shown clinical efficacy in patients with moderate-to-severe ulcerative colitis.


Lead Product(s): Cobitolimod

Therapeutic Area: Gastroenterology Product Name: Kappaproct

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 13, 2022

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Details:

The study will evaluate the efficacy and safety of first-in-class TLR9 agonist cobitolimod for treatment patients with moderate to severe left-sided ulcerative colitis. The phase III program will form the basis for marketing approval of cobitolimod in ulcerative colitis.


Lead Product(s): Cobitolimod

Therapeutic Area: Gastroenterology Product Name: Kappaproct

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 24, 2021

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Details:

The patent provides additional protection for the use of certain dosage regimens of cobitolimod for treating chronic active ulcerative colitis in patients that are not responding or are intolerant to anti-inflammatory therapy.


Lead Product(s): Cobitolimod

Therapeutic Area: Gastroenterology Product Name: Kappaproct

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 16, 2021

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