Alzheon to advance ALZ-801 into Phase II trial in patients with Alzheimer’s disease

Alzheon announced the launch of the company, the securing of initial private financing, and the signing of an exclusive license agreement to a novel clinical drug candidate for Alzheimer’s disease, a family of analogs, and a drug development platform of chemotypes and clinical datasets developed by BELLUS Health of Quebec, Canada.

Alzheon launches as a biotechnology company focused on drug development programs that have been tested in previous efficacy studies in neurodegenerative disorders, and where new insights can be applied to successfully advance a clinical drug candidate.

The company has secured initial financing from strong private investors with long-term vision and a history of exceptional success in building biopharmaceutical companies.

At the outset, Alzheon has a proven management team of seasoned leaders in the field of Alzheimer’s drug development as well as business transactions in neurosciences, including Martin Tolar, MD, PhD, Founder, President and CEO of Alzheon, John Hey, PhD, who has been appointed as Chief Scientific Officer of Alzheon, and Mark Versavel, MD, PhD, MBA, who will serve as Chief Medical Officer of Alzheon.

Drs. Tolar and Hey bring to Alzheon their previous experience at CoMentis, Inc., where they played leadership roles in building the first clinical-stage beta-secretase inhibitor program for Alzheimer’s disease, which culminated in a landmark $1.1 billion transaction with Astellas Pharma in 2008. Dr. Versavel led clinical development of a number of drug candidates in the fields of neurology and psychiatry, including metrifonate for Alzheimer’s disease at Bayer, pregabalin (Lyrica) for neuropathic pain and fibromyalgia at Pfizer, and eslicarbazepine acetate for epilepsy and eszopiclone (Lunesta) for insomnia at Sunovion.

As a result of the exclusive licensing agreement announced today, Alzheon will pursue clinical development of ALZ-801, which is a prodrug of the small molecule tramiprosate, previously in development as BLU8499 by BELLUS Health.

Alzheon’s exclusive license to ALZ-801 also includes rights to a family of analogs, along with an associated platform of chemotypes and clinical datasets.

Together these assets provide Alzheon with a drug development platform with proprietary chemistries as well as extensive clinical and biomarker datasets in Alzheimer’s disease patients, to produce a diverse and novel portfolio of new treatments for neurodegenerative diseases.

BELLUS Health will receive a portion of all future payments received by Alzheon related to ALZ-801 and royalties on future net sales of ALZ-801. Further terms of the license agreement are not disclosed.

Alzheon founder, president CEO Martin Tolar said with limited treatment options and no new approved therapies for Alzheimer’s, there is a tremendous and growing unmet need for effective treatments for Alzheimer’s disease. We see enormous potential in therapeutic approaches that have established clinical proof-of-concept activity in Alzheimer’s disease as well as favorable safety profile. We are making our approach a reality with the current drug candidate in our pipeline, ALZ-801, as well as additional therapeutic assets that we are pursuing or in-licensing. Our experienced drug development team at Alzheon is building on the novel insights into the existing base of clinical data, and is applying innovative drug development approaches to prove efficacy of ALZ-801 as a new treatment for Alzheimer’s disease.

Alzheon CSO John Hey said the past decade of high-profile failures of development programs for Alzheimer’s disease has provided a treasure trove of clinical and biomarker data, as well as new insights into the disease pathogenesis, early diagnosis, clinical trial design and treatment opportunities. Alzheon has unique capabilities to deploy our drug development platform and leverage the clinical knowledgebase from past Alzheimer’s programs to deliver the best of both worlds: innovative treatments for challenging neurodegenerative diseases and well-designed clinical programs that have a high likelihood of success.

Alzheon will advance ALZ-801 into a Phase 2 clinical study in patients with Alzheimer’s disease, guided by the existing clinical data and subpopulation analyses in more than 2,000 Alzheimer’s patients from Phase 3 studies with tramiprosate conducted by BELLUS Health and its predecessor Neurochem Inc.

Alzheon has developed an enhanced clinical program design and patient targeting to successfully evaluate ALZ-801 in those Alzheimer’s disease patients with the potential to receive the strongest benefit from this innovative therapy.

In addition to ALZ-801, Alzheon plans to build a pipeline of novel drug candidates for Alzheimer’s and other neurodegenerative diseases, including new prodrug candidates from its platform as well as additional therapeutic assets from in-licensing activities.