U.S. dementia drug ‘Aduhelm’ stumbles… The pace of drug development by domestic companies

• Despite the attention of the first dementia treatment, controversy over efficacy and safety
  Clinical trials of treatments being developed by domestic companies are progressing smoothly
  On the verge of entering phase 3 clinical trials such as Aribio and Gemvax

Competition for the development of dementia treatment drugs, which had been considered an impossible area, has come to the fore. While ‘Aduhelm (ingredient name: aducanumab)’, which was called the world’s first dementia treatment and received attention, was caught up in controversy over efficacy and safety and failed to perform as expected, clinical trials of latecomers are rapidly progressing. In particular, as clinical trials of domestic development companies are proceeding smoothly, the possibility of a domestic dementia treatment is increasing.

According to the biopharmaceutical industry on the 24th, it is known that the European Medicines Agency (EMA) Drug User Advisory Committee (CHMP) recently expressed a negative opinion about Aduhelm, developed by US Biogen, at a meeting in November.

Although this is an informal process, it seems unlikely that the EMA’s final approval will be difficult unless new information is added prior to the formal meeting scheduled for December.

Earlier, the U.S. Food and Drug Administration (FDA) also received a recommendation against approval of Aduhelm from an advisory committee. However, the FDA decided to accelerate the approval and pushed for approval for Aduhelm last June.

Even after approval of Aduhelm, controversy over efficacy and safety continues. After approval, influential academic journals such as the Journal of the American Medical Association (JAMA) and the British Medical Journal (BWJ) raised questions about its efficacy. In fact, in 2019, during the phase 3 clinical trial, the efficacy did not come out as expected, so the development was at risk of being halted.

Expensive drug prices also caught on. The prescription price for Aduhelm is set at about 66 million won. Among Biogen’s 3rd quarter earnings, Aduhelm’s sales were counted as 300,000 dollars (350 million won). It falls far short of the company’s projected sales of $14 million.

While Aduhelm faltered, the development of other dementia treatments is actively underway. Among global pharmaceutical companies, Lilly and Roche are in phase 3 clinical trials, and clinical results are expected to be announced next year.

Among domestic companies, Aribio and Gemvacs & KAEL are at the forefront. Both companies have completed phase 2 clinical trials and are preparing for phase 3.

Aribio recently announced the results of the US phase 2 clinical trial of ‘AR1001’, an Alzheimer’s disease treatment candidate, at the ‘2021 Alzheimer’s Clinical Association (CTAD)’ held in Boston, USA, and announced that it was about to succeed in developing the world’s first oral dementia treatment. did.

Phase 2 of ‘AR1001’ was conducted for a total of 12 months with 210 Alzheimer’s patients. As a result of administering AR1001 10mg or 30mg for 1 year, similar to the first 6 months clinical trial, no serious drug-related adverse reactions were found and the detected adverse reactions were mild.

Aribio CEO Jeong Jae-joon said, “The long-term safety of AR1001 has been secured through 12-month phase 2 clinical trials in the US. “Unlike existing symptom relievers, it has shown the potential to slow the progression of Alzheimer’s and maintain or improve cognitive function,” he said.

Gemvax also aims to submit a phase 3 clinical trial plan for Alzheimer’s treatment ‘GV1001’ within this year and enter phase 3 from next year.

Mediforum, a natural product new drug development company, has also recently started phase 2b/3 clinical trials of ‘PM012’, a candidate for dementia treatment. About 450 patients will participate in this clinical trial.

An industry official said, “The number of dementia patients is increasing not only in Korea but also around the world due to aging,” said an industry official. will,” he said.

By Son In-gyu, staff reporter

ikson@heraldcorp.com