Takeda this week doubled down on a second coeliac disease project, buying Pvp Biologics only four months after licensing another candidate from Cour Pharmaceuticals. The Japanese company is clearly serious about this space, a field of research that has seen increasing evidence of big pharma interest in the past 12 months or so. Last year Glaxosmithkline bought out Sitari for its enzymatic approach, while Roche signed a deal with Parvus, which is using T cells to achieve immune sensitisation. Still, these collaborations have yet to make it into the clinic; in contrast the projects now owned by Takeda are heading into further mid-stage testing. Pvp and Cour have taken different tacks to treating the extreme immune response seen in sufferers of coeliac disease: the former has developed a “super glutenase” that degrades ingested gluten, while the latter uses encapsulated gluten antigens to induce immune tolerance. The apparent big pharma interest here means that data from the remaining independent players will be watched closely; although another conclusion is that the recent spate of deal making means that business development teams have already given more advanced projects from the likes of Innovate and Immunogenics a close look, and moved on.
Notable coeliac disease projects | ||||
---|---|---|---|---|
Company/sponsor | Project | Mechanism | NCT ID | Notes |
Phase III | ||||
Innovate Biopharmaceuticals | INN-202 | Intestinal tight junction regulator | NCT03569007 | Trial recruiting, completion date in 2021 |
Phase II | ||||
Immunogenics | IMGX-003 | Recombinant gluten-specific protease | NCT03585478; NCT04243551 | Two NIH funded phase II/IIb trials ongoing, results due late 2020 and '21. |
Takeda (Cour Pharmaceuticals) | TAK-101 (CNP-1010) | Gliadin desensitiser | NCT03738475 | Dose ranging studies planned. |
Igy Life Sciences/Vetanda | AGY (food supplement) | Gliadin neutraliser (anti-gluten ummunoglobulin Y) | NCT03707730 | Primary completion due late 2022. |
Dr Falk/Zedira | ZED1227 | TG2 inhibitor | 2017-002241-30 | Started late 2018, no updates since. |
Provention (Amgen) | PRV-015 (AMG 714) | Anti-IL-15 Mab | - | Phase IIb guided to start H1'20 |
Phase I | ||||
Takeda (PVP Biologics) | TAK-062 (Kuma-062) | Glutenase | NCT03701555 | Phase IIb planned |
Preclinical | ||||
Parvus/Roche | Parvus-Roche research project | T cell-targeted immunological tolerance | n/a | No news since Roche deal in May 2019. |
Source: EvaluatePharma, clinicaltrials.gov. |