Combo therapy for inflammation in Parkinson’s may enter clinical trial

COYA-301 aims to promote regulatory T-cells, modulate immune responses

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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A potential anti-inflammatory therapy for Parkinson’s disease may be evaluated in clinical trials within the next year.

The investigative treatment combines a low-dose formulation of interleukin-2 (IL-2) and granulocyte macrophage-colony stimulating factor (GM-CSF), two natural signaling molecules made in the body to help coordinate the activity of immune cells.

Coya Therapeutics will further develop and, if approved, market the therapy, following a recent licensing agreement between the pharmaceutical company and UNeMed, the technology transfer office of the University of Nebraska Medical Center (UNMC).

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“We are incredibility excited about this partnership. Coya is in a great position to develop this new therapy and bring it to the market, where it can have a significantly positive impact on health care,” Michael Dixon, PhD, the president and CEO of UNeMed, said in a university press release.

IL-2 and GM-CSF work to increase the activity of regulatory T-cells, or Tregs, immune cells that help keep the body’s immune system in check, dampening excessive immune and inflammatory responses.

Evidence shows that people with Parkinson’s and other neurodegenerative disorders tend to have elevated inflammation and lower Treg levels. This inflammatory dysregulation is thought to damage and promote the death of nerve cells.

Research conducted in the UNMC labs of Howard Gendelman, MD, and Lee Mosley, PhD, first identified low dose IL-2 as a potential Parkinson’s treatment.

Mice treated with IL-2 at low dose showed increased Treg levels and, importantly, greater survival of dopamine-producing nerve cells, whose loss is a cause of Parkinson’s.

Coya signed an exclusive license agreement with UNeMed in June 2023, acquiring the rights for COYA 301, a low-dose formulation of IL-2 designed to increase the activity of regulatory T-cells and lower inflammation in Parkinson’s disease.

COYA 301 also is being developed as a potential treatment for Alzheimer’s disease. In an early clinical trial in eight people with Alzheimer’s dementia, COYA 301 showed a potential to improve patient’s cognitive scores over four months of treatment.

Findings in a proof-of-concept trial of COYA 302, another Treg-targeting combo therapy, in four amyotrophic lateral sclerosis (ALS) patients suggested that treatment might slow disease progression.

“We believe that Treg dysfunction is the common thread that binds together many neurodegenerative diseases,” said Arun Swaminathan, PhD, Coya’s chief business officer.

Further research at UNMC then combined the IL-2 with GM-CSF. Preclinical data show that the combined therapy led to a four- to six-fold increase in Tregs when compared with either IL-2 at low dose or GM-CSF alone, the university reported.

“These two licenses are based on strong preclinical animal data and builds upon the highly promising clinical data observed in ALS and AD [Alzheimer’s disease], and expands the optionality that Coya has in strategic partnering discussions to execute on future clinical trials in Parkinson’s disease,” Swaminathan said.