Clinical trial failures…novel PD drugs face challenges

Bukwang Pharmaceutical had unmet primary endpoints in a Europe Phase 2 trial

D&D Pharmatech·Peptron failed at phase 2 trials

AbbVie·Amneal continue to develop…K-bio companies speed up clinical trials

Novel candidates for Parkinson’s disease that have gathered the industry’s attention are repeatedly failing to prove effectiveness in clinical trials.

 

Bukwang Pharmaceutical was developing novel drugs for Parkinson’s disease but failed to prove its efficacy in Europe phase 2 clinical trials.

 

D&D Pharmatech and Peptron also failed in phase 2 clinical trials.

 

U.S.

 

Amneal Pharmaceuticals and AbbVie also faced hurdles from the U.S.

 

FDA.

 

Despite of these circumstances, pharmaceutical companies continue to develop novel drugs for Parkinson’s disease and work to turn around failing history.

 

Contera Pharma, Bukwang Pharmaceutical’s subsidiary

According to industry sources on the 22nd, Denmark’s Contera Pharma, Bukwang Pharmaceutical’s subsidiary, announced that the phase 2 trial to confirm the efficacy of JM-010, a novel candidate for Parkinson’s disease, failed to meet the primary endpoint.

 

Contera Pharma specializes in developing neurological disease treatments and was acquired by Bukwang Pharmaceutical in 2014.

 

JM-010 targets Parkinson’s disease’s dyskinesia treatment.

 

It has been developed to lessen involuntary movements of arms, legs, and face in Parkinson’s disease patients.

 

This clinical trial, named Astoria, evaluated the efficacy and safety of JM-010 by administering either JM-010 or placebo in patients with Parkinson’s disease experiencing dyskinesia.

 

The study was conducted at 38 clinical sites across Europe and Asia, including Germany, France, Italy, Spain, Slovakia, and South Korea, and involved 38 patients with Parkinson's disease.

 

The clinical trial included patients who experienced dyskinesia as a side effect of levodopa, which is approved for the treatment of Parkinson's disease.

 

The primary endpoint was the result of dyskinesia reduction, which was evaluated by the Unified Dyskinesia Rating Scale (UDysRS) at 12 weeks.

 

The clinical results demonstrated that the total scores of UDysRS in the low-dose and high-dose groups of JM-010 were reduced by 0.3 points and 4.2 points, respectively, but the values were not statistically significant.

 

For the safety profile, two doses of JM-010 have shown good tolerability, and no adverse reactions have been found in the clinical trial.

 

Contera Pharma is also conducting additional analysis of Astoria’s complete clinical data, including secondary endpoints.

 

The company will disclose the complete clinical results at a major conference.

 

D&D Pharmatech·Peptron fail at phase 2 trials…AbbVie rejected by FDA Clinical trials for Parkinson's disease treatment have failed before.

 

Korean biotech ventures like D&D Pharmatech and Peptron have also experienced challenges in proving efficacy in clinical trials.

 

D&D Pharmatech's NLY01, a glucagon-like peptide-1 (GLP-1) agonist mechanism, failed to demonstrate efficacy in a phase 2 clinical trial in 2020.

 

After 36 weeks of administration, it did not show statistically significant improvement in symptom alleviation compared to the placebo group which was set as the primary endpoint parameter.

 

In detail, at 24 weeks of administration, a significant difference was found between the NLY01 treatment group and the placebo group.

 

However, between 24-36 weeks, the placebo group’s symptoms showed more improvements than those of the NLY01 group.

 

Peptron also failed to secure the efficacy of ‘PT320,’ a Parkinson’s disease candidate drug, in a phase 2 trial in South Korea, which was disclosed in 2022.

 

The PT320 2.0 mg group’s UPDRS part 3 score, which evaluated Parkinson’s disease movement symptoms and was used as the primary endpoint, was not different from the placebo group’s.

 

The PT320 2.5㎎ treatment group showed symptom improvements but failed to demonstrate statistical significance.

 

AbbVie failed to receive FDA approval last year.

 

ABBV-951, under development by AbbVie, has shown significant improvement in the onset time of efficacy compared to Duodopa (active ingredients: carbidopa·levodopa) used as a treatment for Parkinson's disease in phase 3 clinical trials, without exhibiting persistent dyskinesia.

 

When taken once daily, this medication's effects can last 24 hours.

 

However, the FDA has requested further clarification on using the adjunctive exercise device with ABBV-951 and has thus rejected approval.

 

Novel drugs for Parkinson’s disease have failed multiple times in the past…development continues Despite past failures, global pharmaceutical and pharmaceutical and biotech companies in South Korea continue to conduct clinical trials.

 

Amneal Pharmaceuticals’s IPX203 is an oral formulation of levodopa and carbidopa extended-release capsules.

 

Levodopa addresses dopamine shortage, which has been pointed out as the primary cause of Parkinson’s disease.

 

Carbidopa is used as a combination therapy because it can inhibit the conversion of levodopa to dopamine in peripheral nerves.

 

Last year, the FDA found scientific evidence of levodopa’s safety based on pharmacokinetics research last year.

 

However, the FDA requested additional information on Carbidopa due to inadequate proof.

 

The company plans to develop IPX203, which offers longer treatment effects with a lower dose than the conventional formulation.

 

AbbVie plans to receive approval through an additional novel drug candidate in addition to ABB-951.

 

AbbVie is conducting a phase 3 trial through Cerevel Therapeutics, which recently disclosed the top-line results of Tavapadon’s phase 3 trials.

 

Tavapadon is a novel drug candidate for Parkinson’s disease.

 

It is designed as a dopamine D1/D5 receptor partial agonist taken orally once daily to balance motor control activity and drug efficacy.

 

The clinical trial evaluated the efficacy and safety of Tavapadon as a levodopa adjuvant therapy in 507 Parkinson’s patients.

 

Clinical results showed that during the 27-week trial period, the Tavapadon treatment group had a longer duration of Parkinson’s disease remission than the placebo group.

 

AbbVie plans to share additional data from monotherapy trials of TEMPO-1 and TEMPO-2 by the end of this year.

 

The novel drug development for Parkinson's disease continues in the pharmaceutical and biotech industry in South Korea.

 

S.Biomedics is working on stem cell therapy TED-A9, Mthera Pharma is developing the natural drug MT-101, and Kainos Medicine is targeting the Fas Associated Factor 1 (FAF1) protein with KM-819.

 

Additionally, ABL Bio is working on a dual antibody, ABL-301.

 

Pipelines of pharmaceutical and biotech industry in Korea: Bukwang Pharmaceutical, S.Biomedics, Mthera Pharma, Kainos Medicine, ABL Bio, Hanall Biopharma, and Ildong Pharmaceutical.