Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical candidates from proof-of-concept through to regulatory approval, announced that it has opened an Investigational New Drug (IND) application for a phase 2 study in plaque psoriasis under its co-development agreement with Merck (Darmstadt, Germany), a leading science and technology company. Avillion and Merck signed a co-development agreement in 2017 under which Avillion will develop, and finance the development of M1095, Merck's anti IL-17 A/F Nanobody from phase 2 through phase 3 to regulatory submission.
Avillion is focused on this collaborative approach to advancing the development of late-stage clinical candidates for pharmaceutical company partners. Avillion provides development expertise in addition to financing, with the aim of boosting R&D productivity for its partners. Avillion's first co-development agreement saw the Company successfully conduct a phase 3 trial of Pfizer's BOSULIF (bosutinib), which led to its accelerated approval in the US in December 2017 for newly-diagnosed chronic phase Ph+ chronic myelogenous leukemia (CML).
The new trial with M1095 is a phase 2b randomized, double-blind, placebo controlled, multi-centre study designed to assess its efficacy, safety and tolerability in up to 300 subjects with moderate to severe chronic plaque-type psoriasis (NCT identifier NCT03384745).
Allison Jeynes-Ellis, MD, CEO of Avillion, said: "We are delighted with the progress being made in our collaboration with Merck. Development of the novel bi-specific nanobody M1095 is our second major product development opportunity following the success with Pfizer's BOSULIF, and to receive FDA acceptance of our IND for a phase 2 trial is the first operational milestone in this project. We are pleased with how industry awareness of the capabilities of the team is growing and look forward to announcing further developments in the future."
In less than five years, Avillion has entered into co-development agreements under both US and EU accounting principles (GAAP and IFRS), conducted a Phase 3 programme, secured an accelerated approval for one product, and opened an IND with a planned Phase 2 trial for second candidate.
The Anti IL-17 A/F Nanobody M1095 is an investigational bi-specific half-life-extended Nanobody that is thought to neutralise both IL-17A and IL-17F with the potential to treat inflammatory diseases. Due to the small size and unique structure of Nanobodies, they could be an ideal building block for a new generation of novel biological drugs. Merck acquired full, exclusive rights to anti IL-17 A/F Nanobody through a global development and commercialisation deal with Ablynx in 2013. Avillion entered into a co-development agreement with Merck for the Phase 2 and Phase 3 development of the candidate in March 2017.