Alzheimer’s drug gantenerumab disappointed in clinical studies

Roche building

The Swiss have suffered another setback in Alzheimer’s research.

(Photo: RERUTERS)

Zurich The pharmaceutical company Roche and its German partner Morphosys have to accept a new setback in the development of their Alzheimer’s drug. As Roche announced on Monday morning, the active substance gantenerumab missed the goal of significantly delaying the progression of the disease in early-stage Alzheimer’s patients in two larger studies.

This has dashed hopes that this drug could still play a role in the fight against Alzheimer’s. Roche had tested the active ingredient in two studies with almost 2,000 participants over a relatively long period of 27 months. Half of the participants received either gantenerumab or a placebo.

A slight delay in cognitive decline of eight and six percent was observed in the treated patients in both studies. However, the results were not statistically significant. That said, the odds that they were just due to chance were relatively high — nine percent in one study and almost 30 percent in the second study.

Gantenerumab is directed against certain protein deposits in the brain cells, the so-called beta-amyloid plaques, which many researchers previously considered a contributing factor in Alzheimer’s dementia. The active ingredient had previously failed in previous studies, as had numerous other drug candidates that attacked the amyloid deposits.

Top jobs of the day

Find the best jobs now and
be notified by email.

However, confidence in the molecule and the entire amyloid hypothesis has recently grown in the pharmaceutical industry after a similar active ingredient from the pharmaceutical companies Biogen and Eisai was able to show surprisingly positive data in a large study a few weeks ago. Lecanemab slowed mental loss in patients by 27 percent and is now pending approval in the US. In Europe, Biogen and Eisai intend to apply for approval next year.

Roche shares fall significantly

Gantenerumab followed a similar principle of action as Biogen’s competitor product. It is also an antibody, i.e. a special protein molecule with very specific binding properties. And Gantenerumab was also aimed at eliminating the amyloid deposits. The molecule is based on the antibody technology of the Munich biotech company Morphosys, which, if successful, would have been entitled to license claims of 5.5 to seven percent of sales.

>> Also read: Diabetes drug with multi-billion potential: Eli Lilly is the new star of the pharmaceutical industry

Investors reacted with some disappointment to the results on Monday. Roche’s share price fell by almost five percent on Monday morning, and Morphosys even lost almost 30 percent in value, although the biotech company had already sold 60 percent of its potential license rights to gantenerumab to Royalty Pharma last year.

In view of the numerous failures in Alzheimer’s research, many analysts were already rather skeptical about Roche’s project. In any case, the estimates for Roche’s sales have always refrained from considering Alzheimer’s-related sales, wrote Vontobel analyst Stefan Schneider in a comment on the test data. “For the simple reason that Alzheimer’s studies seemed too risky to us because of the unproven beta-amyloid theory.”

Roche’s failure follows a series of other flops in other areas, such as the development of new drugs to treat lung cancer. In addition, another Alzheimer’s project that the Basel-based group had pursued with the biotech company AC Immune had previously failed.

“Accordingly, the train seems to have left Basel for Alzheimer’s drugs,” commented Michael Kunz, analyst at the Luzerner Kantonalbank. If successful, experts had expected gantenerumab to generate peak sales of up to ten billion dollars a year.

Position of Biogen and Eisai is strengthened

To what extent Roche’s new failure will give new impetus to critics of the amyloid hypothesis remains to be seen. Because the pharmaceutical company pointed out that the degradation of the amyloid plaques in the treated patients was lower than originally expected. In this respect, the weak test results do not necessarily appear to be proof that the basic assumption is incorrect. They could also be based on the fact that the agent did not sufficiently bring about the desired biological effect, i.e. the reduction of deposits.

Given the results, gantenerumab should no longer play a role in the race for Alzheimer’s therapy. This in turn could strengthen the position of Biogen and Eisai should their active ingredient actually receive regular approval in the coming year as intended. Biogen shares rose about 4 percent in premarket trading in response to weak data from Roche. The need for Alzheimer’s drugs is considered to be huge, as there are currently no effective therapies. Market observers therefore believe that successful products can generate sales in the double-digit billions.

The only potential competitor left is an anti-amyloid drug from the US company Eli Lilly, for which clinical data from a larger study are expected in the coming year. Most other development projects in Alzheimer’s are still in the earlier stages of clinical development.

More: New hope for Alzheimer’s patients: Medication from Biogen and Eisai scores in study

source site-13