Funding to finish ongoing Part 3 trial and business launch of first oral disease-modifying remedy for Alzheimer’s.
Medical-stage biotech Alzheon has accomplished a $100 million Sequence E financing spherical to advance the event and commercialization of its oral drug for Alzheimer’s illness. The drug, referred to as ALZ-801 (valiltramiprosate), is designed to inhibit the formation of soluble poisonous beta amyloid oligomers, that are implicated within the cognitive decline noticed in Alzheimer’s sufferers. The small molecule acts upstream of different late-stage amyloid-targeting remedies, providing a probably simpler intervention by addressing the early formation of neurotoxic aggregates.
The brand new funding might be used to finish the present APOLLOE4 Part 3 research to judge the efficacy and security of ALZ-801 in sufferers with early Alzheimer’s illness. It’ll additionally help Alzheon’s plans to submit a New Drug Utility (NDA) in 2024 based mostly on the research’s outcomes, in addition to getting ready the manufacturing processes and business launch of ALZ-801, which is probably the primary oral disease-modifying remedy for Alzheimer’s.
“This newest fundraising ensures that we are going to have adequate capital to finish our pivotal Part 3 program and put together commercialization of oral ALZ-801/valiltramiprosate with runway properly into 2026,” stated Ken Mace, CFO of Alzheon. “ALZ-801 has the potential to disrupt the Alzheimer’s therapy paradigm by slowing the development of this relentless and debilitating illness, and the outcomes from our pivotal APOLLOE4 Part 3 trial will set the stage for the potential NDA submitting this yr, adopted by the U.S. business launch in 2025.”
The pivotal APOLLOE4 Part 3 research significantly targets sufferers with two copies of the APOE4/4 gene, a high-risk group that constitutes roughly 15% of Alzheimer’s sufferers, together with actor Chris Hemsworth. The research, which has screened over 6,000 sufferers and enrolled 325 topics, will conclude within the third quarter of 2024. Optimistic outcomes might pave the best way for regulatory approval and subsequent commercialization.
“We’re on the daybreak of a brand new period within the therapy of Alzheimer’s illness, and our novel therapeutic strategy has a chance to rework the usual of care and enhance entry to therapy for all Alzheimer’s sufferers,” stated Dr Martin Tolar, CEO of Alzheon. “Our well-differentiated drug candidate with a positive security profile, displaying no elevated danger of vasogenic mind edema in additional than 3,000 AD sufferers, is positioned to probably develop into the primary oral illness modifying remedy for the therapy of Alzheimer’s illness.”
Along with the Part 3 research, ALZ-801 has been evaluated in a two-year Part 2 biomarker trial involving 84 sufferers, together with 31 APOE4/4 homozygotes. This trial, accomplished in late 2023, is at present in a fourth-year extension section. The research’s main aim is to evaluate the consequences of ALZ-801 on biomarkers of Alzheimer’s pathology, alongside its medical efficacy, security, tolerability, and pharmacokinetic profile over 208 weeks of therapy.
Alzheon envisions extending the usage of ALZ-801 past APOE4/4 homozygotes to incorporate sufferers with one copy of the APOE4 gene and even noncarriers. The corporate says additionally it is specializing in a future precision medication strategy, leveraging particular person genetic and biomarker info to tailor therapies that supply the best profit to particular affected person subsets.
The funding spherical, which was led by Alerce Medical Expertise Companions, follows a $50 million Sequence D spherical accomplished in 2022.
“At Alerce, we deal with investing in firms within the late phases of improvement which can be growing lifesaving medicine or units with the potential to learn thousands and thousands of affected person lives,” stated Muneer Satter, Managing Accomplice of Alerce. “Alzheon’s ALZ-801 gives an modern precision-medicine resolution in an rising Alzheimer’s pipeline with a path to potential approval in 2025.”
