Alzheimer’s drug development roundup – July 2024

In July, the pharmaceutical industry observed a series of new developments within Alzheimer’s treatment space. This includes the release of exciting clinical data and major regulatory assessments for these medicines.

In its meeting on 22-25 July 2024, the European Medicines Agency (EMA)’s human medicines committee established its decision about an EU marketing authorisation for Leqembi^® (lecanemab).

Considering the group held a negative opinion on its authorisation in this region, Eisai stated it will seek that the Committee for Medicinal Products for Human Use (CHMP) re-examines its decision. “We are extremely disappointed by the CHMP’s negative opinion and understand that this may also be disappointing for the wider Alzheimer’s disease (AD) community,” commented Dr Lynn Kramer, Chief Clinical Officer at Eisai.

This news follows exciting regulatory approvals of the medicine in Hong Kong, then Israel, in the second week of July.

According to GlobalData, the launch of Leqembi (lecanemab) in China last month is a “pivotal” moment in the treatment Alzheimer’s. It is the third country to have authorised the medicine.

“Given the rising prevalence of AD, the launch of Leqembi in China is timely and crucial”, noted Chilamula Srija, Pharma Analyst at GlobalData.

The organisation predicted that Leqembi will generate $13 million in sales this year and “grow to $398 million in 2030, at a CAGR of 76.9 percent in the Chinese market”.

Market competition

“The emergence of new Alzheimer’s disease therapies [in recent years] has demonstrated that we are increasingly capable of treating a condition once deemed untreatable, and the next step in this endeavour is to develop a therapeutic that is both safe and effective,” Dr Nataliya Agafonova, Chief Medical Officer at Longeveron Inc. commented, following the presentation of new data for the company’s Alzheimer’s cell therapy.

Last month, Eli Lilly’s donanemab was approved by the US Food and Drug Administration (FDA) as Kisunla™ (donanemab-azbt). The firm noted that it is the first amyloid plaque-targeting therapy using a limited-duration treatment regimen based on amyloid plaque removal.

Srija asserted that the treatment “could present substantial competition to Leqembi given their similar mechanisms of action targeting Aβ. While Leqembi requires biweekly administration, donanemab’s monthly dosing could reduce hospital visits by half, presenting a potential advantage in patient convenience. However, Leqembi has the first-mover advantage”.

Alzheimer’s Association International Conference^® (AAIC) – promise of treatment potential

Study results presented at the 2024 Alzheimer’s Association International Conference (AAIC) found that the cell therapy Lomecel-B™ had promising therapeutic potential.

Specifically, the treatment enabled a 49 percent reduction in brain volume loss, based on data from the CLEAR MIND Phase IIa clinical trial. Critically, the therapy demonstrated an overall slowing of disease worsening, according to the biotech Longeveron.

Moreover, the safety profile of Lomecel-B was positive. For example, no cases of amyloid-related imaging abnormalities (ARIA) were reported, Longeveron added.

“As a medicinal signalling cell therapy that has multiple potential mechanisms of action to address inflammatory responses in the brain, Lomecel-B offers potential to address the underlying pathology of Alzheimer’s disease without the limitations of previous therapies,” shared Wa’el Hashad, Chief Executive Officer at Longeveron.

Lecanemab – further clinical developments

In a positive update for Leqembi, separate data presented at AAIC demonstrated its benefit for early Alzheimer’s, in patients given three years of continuous treatment. Eisai and Biogen highlighted that Lecanemab “is the only widely available early Alzheimer’s treatment that offers a dual mechanism of action designed to selectively target highly toxic protofibrils in addition to amyloid plaques”.

In the optional tau PET substudy of the Clarity AD Phase III clinical trial, 51 percent of No Tau / Low Tau patients showed improved cognition and function over three years with the biologic. A total 59 percent of these patients showed improvement or no decline, according to the data.

Eisai and Biogen also shared that from the results presented at AAIC, in the “off-treatment period of 9-59 months following the 18-month core study…Lecanemab’s clinical effect was maintained”.

Other biotechs advancing the Alzheimer’s field

Furthermore, Vaccinex, Inc. also presented data for a promising biologic at AAIC.

Topline data from the Phase Ib/II SIGNAL-AD trial clinical trial, suggested the potential of the anti-Semaphorin 4D (SEMA4D) humanised IgG4 monoclonal antibody pepinemab.

“We believe that results of the SIGNAL-AD study demonstrate that pepinemab has a similar effect in Alzheimer’s to those we previously described for a key outcome in Huntington’s disease, preventing the characteristic disease-related decline of brain metabolic activity in a brain region known to be affected early in disease progression,” remarked Maurice Zauderer, PhD, Vaccinex’s CEO.

He continued, stating that based on the data, “pepinemab may be most effective in patients with very early-stage symptoms, eg, mild cognitive impairment (MCI) due to Alzheimer’s, but not subsequent dementia”.

Taking a wider view of the current Alzheimer’s treatment landscape, GlobalData’s Srija surmised that the growing pipeline “is good news for patients, potentially offering more therapy options.”