Denovo Biopharma Acquires Global Rights to Experimental Alzheimer’s Drug

Alzheimer's

With the multiple failures in targeting amyloid plaque in the treatment of Alzheimer’s disease, San Diego-based Denovo Biopharma is taking a different approach by targeting the Alpha2C adrenoceptor.

On Tuesdau, the company announced it licensed ORM-12741 from Finland-based Orion Corporation. The new asset, now known as DB105, is a highly potent and selective alpha-2c adrenoceptor (AR) antagonist. The asset will be assessed as a potential treatment for neuropsychiatric indications such as Alzheimer's disease, schizophrenia, and depression, among others. Under terms of the deal with Orion, which were not disclosed, Denovo has gained global rights to develop, manufacture and commercialize DB105.

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Denovo Chief Executive Officer Wen Luo said most companies that have gone after Alzheimer’s, such as Biogen and Eli Lilly, had programs aimed at beta amyloid or tau. DB105 offers a distinct mechanism of action by targeting the alpha-2c adrenoceptor, Luo said.

“Despite the failures of most Alzheimer's drug development programs across the pharmaceutical industry, we believe our biomarker platform and targeted personalized medicine approaches may provide a breakthrough to address this serious unmet medical need,” Luo said in a statement.

When DB205 was under development by Orion, the drug had shown some promise in treating patients with Alzheimer’s. Results of a 2013 Phase II study showed that ORM-12741 demonstrated significant positive effects on episodic memory in patients with moderate Alzheimer's disease. After three months, the patients who took ORM-12741 tested higher on the tests of memory compared to those who received the placebo pill, Orion announced at the time of the study.

In its announcement today, Denovo said more than 540 patients across 11 clinical studies have been dosed with ORM-12741. The drug has been found to be safe and well-tolerated, the company said. The information generated from those previous studies will provide a rich data set for Denovo to conduct its biomarker discovery, the company said.

In its announcement, Denovo did not outline its planned developmental steps for DB105 but noted that more licensing is likely to come to expand the company’s pipeline. Michael Haller, Denovo's chief business officer, said the licensing of the new asset provides Denovo with four late-stage compounds in oncology and neurology. Haller said Denovo intends to expand its portfolio in these two therapeutic areas.

Haller said the company has pushed its lead asset DB102 (enzastaurin) into a Phase III trial as first-line therapy for the treatment of Diffuse large B-cell Lymphoma. That asset, which it acquired from Eli Lilly, is also Phase III-ready in a glioma study. DB102 has received orphan drug certification in the U.S. and Europe. A data readout for the Phase III DLBCL trial is expected in mid-2021, the company said.

In addition to DB102 and the newly licensed DB105, the company has two additional late-stage programs targeting CNS diseases. DB103 is in development for schizophrenia and DB104 is in development for depression.

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