HomeCorporateNeurizon Enters Long-Term Agreement with Elanco Strengthening Commercialisation Readiness

Neurizon Enters Long-Term Agreement with Elanco Strengthening Commercialisation Readiness

  • Neurizon executes long-term supply agreement with Elanco Animal Health (Elanco), with an initial five-year term

  • The agreement provides long-term access to GMP monepantel, the active pharmaceutical ingredient in Neurizon’s lead asset, NUZ-001

  • Agreement represents an important commercialisation milestone and materially strengthens Neurizon’s long-term manufacturing and supply chain readiness

  • Execution further strengthens Neurizon’s position as a clinically advanced, capital efficient neurodegenerative disease company with a defined regulatory and commercialisation pathway

Elanco continues its strategy to augment its “Innovation Portfolio” and as part of this strategy, it has entered in a long term supply arrangement with Neurizon for commercialization of Monepantel in Companion Animals.

Monepantel (MPL) is an oral aminoacetonitrile (AAD) compound that modulates the mTOR pathway, which is recognised as a key driver of cancer.  Neurizon is evaluating MPL for treatment of lymphomas and other cancers in companion animals.

An estimated 6 million dogs are diagnosed with cancer in each year in the US compared to 1.7 million humans.  Many of the most common cancers in dogs (eg. Lymphoma, Osteosarcoma, Mammary) are recognised as being very similar to human cancers.  As such, dogs are increasingly recognised as excellent models for human disease.

The agreement with Elanco represents a major milestone for Neurizon and demonstrates the Company’s focus on capital efficient commercialisation readiness. The agreement furthers the Company’s collaboration with Elanco, as NUZ-001 (Monepantel) progresses through late-stage clinical development via the Phase 2/3 HEALEY ALS platform trial and into commercialisation.

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As such, dogs are increasingly recognised as excellent models for human disease, Neurizon – PharmAust’s strategy is to develop MPL as a novel therapy to treat common cancers in dogs and then use this information to inform and de-risk its human clinical development programme.

As MPL is already registered as a parasiticide for use in animals Neurizon intends to significantly reduce the cost and time required to register a new treatment for pets.  Further, PharmAust has shown that MPL is a cost-effective, safe and potent therapy which, meets the unique combination of criteria required to generate a commercial return in the companion animal drug market.

MPL Clinical Trials in Dogs Diagnosed with Cancer

In a Phase I trial conducted in dogs diagnosed with solid tumours, Monepantel (MPL) was shown to be well tolerated and reported as beneficial to Quality of Life (QOL) in canines with cancer doses up to 25 mg/kg bw daily either as monotherapy or at 5 mg/kg bw in combination with carboplatin. Further, MPL dosed at 5 mg/kg bw daily in canines with “standard of care” treatment-refractory cancer effectively and significantly reduces blood levels of the cancer-specific marker p-Rbps6k.

In a Phase 2 pilot programme, dogs diagnosed with lymphoma were treated with MPL as front-line therapy with doses up to 25mg/kg/day for two weeks before transitioning to standard therapy.  Results showed that 100% of dogs diagnosed with B-cell lymphoma developed the stable disease and showed evidence of tumour regression with minimal side-effects following MPL treatment. Lymphoma in dogs is very aggressive and, without treatment, the tumours are often fatal within weeks.

With this deal, Elanco plans to have access to growing pet animals’ oncology segment and help Vet Oncologists and Pet Parents with re-purposed drugs for common canine cancers.

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