GNT Pharma’s anti-dementia drug shows efficacy in study
Therapies for fibrotic diseases
YONGIN, South Korea, Jan 15, (AP): GNT Pharma has successfully completed a Phase III clinical trial for crisdesalazine, a new drug for treating canine cognitive dysfunction syndrome or Alzheimer’s disease.
In the clinical study conducted with 48 companion dogs with severe cognitive dysfunction at 7 veterinary hospitals including Seoul National University Animal Hospital, crisdesalazine-treated group demonstrated outstanding and significant efficacy compared to the placebo group in canine cognitive dysfunction rating scale, the primary outcome measure, as well as in canine dementia scale, the secondary outcome measure. Efficacy was identified both at the 4-week and 8-week treatment in companion dogs that received 5 mg/kg or 10 mg/kg of crisdesalazine. No adverse events were found in relation with the administration of crisdesalazine.
Davis research group at the University of California reported that 28% of companion dogs aged 11-12 and 68% of such dogs aged 15-16 suffer from cognitive dysfunction. As lifespan of companion dogs increases thanks to the advancement in veterinary science and healthcare, their dementia prevalence rate is on the rise. But the increase in companion dogs with dementia is emerging as a serious socio-economic problem due to the unavailability of treatment for dogs with dementia.
Antioxidant
Crisdesalazine is a multi-target drug developed to provide strong antioxidant effect and safe anti-inflammatory action to prevent amyloid plaque, neurofibrillary tangle, and neurodegeneration that cause Alzheimer’s disease and companion dog’s dementia. Earlier, scientists at GNT Pharma proved that crisdesalazine reduced amyloid plaques and neuronal death while improving cognitive function in the Alzheimer’s disease mice models.
“Demonstration of safety and outstanding efficacy of crisdesalazine in companion dogs with dementia is a groundbreaking outcome and we recently filed an application for the PCT patent,” said Dr Jin Hwan Lee, Head of GNT Pharma Animal Healthcare Division.
“We expect to complete its Phase II clinical study in 2-3 years for patients with Alzheimer’s disease,” said Dr Byoung Joo Gwag, CEO of GNT Pharma and inventor of crisdesalazine. “We plan to submit an application to the Ministry of Food and Drug Safety in the second half year for the clinical study of crisdesalazine for treating Alzheimer’s disease.”
Fibro-inflammatory
diseases:
Boehringer Ingelheim and Enleofen Bio Pte Ltd (Enleofen) has announced that the acquisition of worldwide exclusive rights to Enleofen’s preclinical interleukin-11 (IL-11) platform by Boehringer Ingelheim to develop first-in-class therapies across a broad range of fibro-inflammatory diseases. The new partnership combines Boehringer Ingelheim’s leading expertise and comprehensive pipeline in fibrotic diseases with Enleofen’s
world-leading expertise in IL-11 biology and the company’s extensive range of therapeutic antibodies targeting this pathway.
“The impressive preclinical studies at Enleofen have revealed the potential of IL-11 blockade to treat a broad range of diseases,” said Clive R. Wood, PhD, Corporate Senior Vice-President and Global Head of Discovery Research at Boehringer Ingelheim. “We are excited to have these monoclonal antibodies in our pipeline and have the opportunity to accelerate their path to many patients whose needs are not met by current treatments.”
IL-11 is a cytokine, a protein certain cells of the body use to communicate, and plays a key role in fibro-inflammatory conditions. Blocking IL-11 action has been shown to inhibit disease across many organs (liver, lung, kidney, retina, bowel, heart and skin). In preclinical studies, antibody-based IL-11 antagonists were able to prevent and reverse inflammation and fibrosis, and restore organ function.
Enleofen is a spin out company from the National Heart Centre Singapore (NHCS) at SingHealth and Duke-NUS Medical School under the SingHealth Duke-NUS Academic Medical Centre (AMC), Singapore and exclusively licensed a suite of patents and number of antibody products when it was founded in 2017, from the AMC. Subsequent to this, Enleofen has built an extensive anti-IL-11 antibody platform and advanced its drug development programs towards the clinic.
Expand
Boehringer Ingelheim will now develop this platform further and plans to work jointly with scientists at the AMC to accelerate the platform into clinical development. The initial focus will be on novel therapies for patients with NASH and ILDs, two of Boehringer Ingelheim’s core disease focus areas, with a potential to expand into further fibro-inflammatory conditions based on IL-11’s central role in disease.
“Enleofen is very excited to engage Boehringer Ingelheim, a leader in anti-fibrotic therapy R&D to develop further anti-IL-11 therapies to begin to address the unmet medical needs of patients worldwide,” said Prof Stuart Cook, Director and co-founder of Enleofen. “The preclinical data across a range of conditions are unprecedented and this new approach of targeting IL-11 could be a game changer”.
The acquisition of the IL-11 program from Enleofen strengthens Boehringer Ingelheim’s pipeline portfolio, which combines approaches that are effective across multiple fibrotic diseases with disease-specific approaches to achieve greater therapeutic effect and builds on the experience gained with nintedanib in fibrotic lung diseases. Boehringer Ingelheim will be solely responsible for the clinical, regulatory and commercial development of the licensed therapies. Under the terms of the agreement, Enleofen may receive earn out payments in excess of one billion USD per product in upfront and success-based development and commercialization milestones.