exenatide SR two-week formulation (PT320) / Peptron - LARVOL DELTA

Attenuating mitochondrial dysfunction and morphological disruption with PT320 delays dopamine degeneration in MitoPark mice. (PubMed, J Biomed Sci) - "Our findings suggest that the early administration of PT320 shows potential as a neuroprotective treatment for PD, as it can preserve mitochondrial function. Through enhancing mitochondrial health by regulating Opa1 and Fis1, PT320 presents a new neuroprotective therapy in PD."

Journal • Preclinical • CNS Disorders • Metabolic Disorders • Movement Disorders • Ocular Inflammation • Parkinson's Disease • OPA1

PT320, a Sustained-Release GLP-1 Receptor Agonist, Ameliorates L-DOPA-Induced Dyskinesia in a Mouse Model of Parkinson's Disease. (PubMed, Int J Mol Sci) - "Moreover, early treatment with PT320 was shown to not only increase tonic and phasic release of DA in striatal slices in L-DOPA-naïve MitoPark mice, but also in L-DOPA-primed animals. Early treatment with PT320 ameliorated L-DOPA-induced dyskinesia in MitoPark mice, which may be related to the progressive level of DA denervation in PD."

Journal • Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Despite failing phase 2a clinical trials, Peptron not giving up on Parkinson’s treatment (Korea Biomedical Review) - P2a | N=99 | NCT04269642 | Sponsor: Peptron, Inc. | "Peptron said...that it failed to secure statistical significance of the primary endpoint for its Parkinson’s disease treatment candidate (PT320) in phase 2a clinical trials but will continue developing the drug....According to the public disclosure, there was no statistical significance between test group 1 and the placebo group for the mean change of MDS-UPDRS part 3 score (p=0.7355). Similarly, when comparing test group 2 and the placebo group, although the motor symptoms improved in test group 2, there was no statistical significance between the groups (p=0.5042). Meanwhile, secondary outcomes like the K-PDQ-39 score, an indicator for evaluating the quality of life such as daily living ability, showed a statistically significant improvement compared to the placebo group."

P2a data • CNS Disorders • Parkinson's Disease

Invex believes in Peptron and goes… Joint development of brain disease treatment ’joint hand’ [Google translation] (eDaily) - "New drug developer Peptron...is expanding the scope of cooperation with Australian pharmaceutical company Invex Therapeutics (hereafter Invex) to develop treatments for brain diseases....Peptron announced on its website on the 21st that it had signed a memorandum of understanding (MOU) with Invex to verify additional indications for PT320, which is being developed as an IIH treatment. The goal is to jointly develop a treatment for brain diseases. According to the announcement, the two companies will first confirm the possibility of developing a treatment for diseases caused by multiple system atrophy (MSA) and acquired traumatic brain injury (TBI) among neurodegenerative diseases."

Licensing / partnership • CNS Disorders • Multiple System Atrophy

Peptron and Imperial College UK and 'PT320' Alzheimer's disease phase 2 joint research MOU [Google translation] (Pharm News) - "Peptron...recently signed a memorandum of understanding (MOU) with Imperial College, UK for 'PT320', and started work on this contract for joint research on Alzheimer's indications for phase 2 clinical trials on the 29th. said."

Licensing / partnership • Alzheimer's Disease • CNS Disorders

“Peptron will enter PT320 Alzheimer’s global phase 2 within this year” [Google translation] (Hankyung) - “At the '2022 Korea Bioinvestment Conference (KBIC 2022)' held on the 11th, Peptron Managing Director Jang Seung-gu said, ‘The domestic phase 2 clinical trial of PT320 for Parkinson's disease is currently in the final stage, and the global clinical trial for Alzheimer's disease will enter phase 2 within this year.’”

New P2 trial • Alzheimer's Disease • CNS Disorders

Ministry of Food and Drug Safety, Peptron Parkinson's disease treatment 'PT320' approved for therapeutic use [Google translation] (Pharm News) - "Peptron...announced...that it had received 'therapeutic use approval' from the Ministry of Food and Drug Safety for PT320, a GLP-1 type Parkinson's disease treatment. The 'therapeutic use approval' system is a system in which the Ministry of Food and Drug Safety permits the use of clinical investigational drugs only for therapeutic purposes before obtaining product approval in order to provide treatment opportunities to patients with severe life-threatening diseases who do not have alternative treatment methods. This system is being operated in various countries such as the United States and Europe only for drugs approved for clinical trials."

Non-US regulatory • CNS Disorders • Parkinson's Disease

Peptron acquires US patent for PT320, a candidate drug for Parkinson's disease [Google translation] (Health Korea News) - "Peptron...acquired a US patent for PT320, a candidate substance for treating Parkinson's disease....According to the company on the 17th, the recently registered patent is a patent for the treatment of neurodegenerative diseases of the GLP-1 family of peptides technology introduced by the National Institutes of Health (NIH) in the form of excellent penetration of the blood-brain barrier (BBB). Peptron's unique technology, SmartDepot technology, was applied to expand the scope of rights throughout the CNS."

Patent • Alzheimer's Disease • CNS Disorders • Multiple System Atrophy • Parkinson's Disease

Peptron Parkinson's disease phase 2 clinical trial results imminent.. Generate 2 trillion won in sales when commercialized [Google translation] (eDaily) - "New drug development company Peptron...faces a turning point this year. 'We will officially announce the results of the PT320 clinical trial within the fourth quarter at the latest, and based on this, we will advance into the Alzheimer’s treatment market in earnest'....As soon as the results of phase 2 clinical trials are announced, phase 3 clinical trials and technology transfer with global pharmaceutical companies will be pursued."

P2 data • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

Peptron to participate in Bio-Europe 2021… Concentrate on expansion of drug efficacy continuity platform business [Google translation] (Pharm News) - "Peptron...will participate in 'Bio-Europe 2021' to be held from the 25th to the 28th (local time)....At this event, Peptron will hold various meetings to expand the technology business of its drug sustainability platform 'SmartDepot'. In particular, the company plans to initiate discussions on partnering and global copyright licensing for three candidate substances for the GLP-1 series long-acting drug that can be produced directly at its own GMP facility. The three pipelines are Parkinson's disease treatment 'PT320'..."

Licensing / partnership • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

Sustained Release GLP-1 Agonist PT320 Delays Disease Progression in a Mouse Model of Parkinson's Disease. (PubMed, ACS Pharmacol Transl Sci) - "Positron emission tomography showed protection of striatal DA fibers and tyrosine hydroxylase protein expression was augmented by PT320 administration. Early PT320 treatment may hence provide an important neuroprotective therapeutic strategy in PD."

Journal • Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease

SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's Disease (clinicaltrials.gov) - P2a; N=99; Active, not recruiting; Sponsor: Peptron, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

An extended release GLP-1 analogue increases α-synuclein accumulation in a mouse model of prodromal Parkinson's disease. (PubMed, Exp Neurol) - "The repurposing of drugs developed to treat type 2 diabetes for the treatment of Parkinson's disease (PD) was encouraged by the beneficial effect exerted by the glucagon-like peptide 1 (GLP-1) analogue exenatide in a phase 2 clinical trial...Thirteen weeks after PFF injection, mice treated with long-acting the GLP-1 analogue had a significant increase in pathological α-syn in brain regions connected to the olfactory bulb, accompanied by signs of microglia activation. Our results suggest that the nature of the neuronal insult and intrinsic properties of the targeted neuronal population markedly influence the effect of GLP-1 analogues."

Journal • Preclinical • CNS Disorders • Diabetes • Metabolic Disorders • Movement Disorders • Parkinson's Disease • Type 2 Diabetes Mellitus

Peptron, paid the gift money... Management category crisis avoidance [Google translation] (Paxnet News) - "With this share payment, convertible bonds (CB) worth 25.5 billion won will be redeemed every three months starting from January next year. In addition to using 25.5 billion won of the funds raised this time for debt repayment, Peptron decided to use 44.3 billion won for operating funds and 1.3 billion won for issuance fees. The operating funds are invested in promoting the clinical and commercialization of major pipelines....Peptron has a pipeline of...Parkinson's disease treatment 'PT320'...PT320 started phase 2 clinical trials in Korea in the first quarter of this year."

Financing • CNS Disorders • Parkinson's Disease

Peptron, 33% of the CEO decided to participate in the capital increase [Google translation] (eDaily) - "Peptron (087010) announced on the 10th that CEO Ho-il Choi has decided to purchase 33% of the total allocation for a capital increase....'In order to further stabilize management rights by maintaining a sufficient stake even after the bequest, the CEO's participation rate in the bequest has been significantly increased from the original plan'...The funds inflow through the bequest will be used to promote clinical and commercialization of major pipelines such as...Parkinson's new drug 'PT320'..."

Financing • CNS Disorders • Parkinson's Disease

Peptron licenses out Alzheimer's drug candidate to Harvard University (Korea Biomedical Review) - "Peptron said that it has signed a licensing agreement with Harvard University to evaluate the efficacy of PT320, a treatment for Parkinson's disease, as a possible treatment candidate for Alzheimer's disease."

Licensing / partnership • Alzheimer's Disease • CNS Disorders

Technology export is possible if peptron management item crisis is over, Choi Ho-il suspended capital increase [Google translation] (businesspost.co.kr) - "Peptron is conducting phase 2 clinical trials in Korea for 'PT320', a treatment for Parkinson's disease...An official from Peptron said, 'PT320 is expected to be able to export technology in the next year when the phase 2 clinical trial in Korea is expected to end.'"

Trial status • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

Peptron decides to increase capital by KRW 75 billion… Secured funding for clinical and commercialization of major pipelines [Google translation] (Maekyung Media Group) - "Peptron announced on the 15th that it has decided on a paid-in capital increase...allocating 75 billion won to shareholders to finance the clinical and commercialization of major pipelines. The funding will be used to...promote clinical development of new Parkinson's disease drug 'PT320'....'PT320' is currently undergoing phase 2 clinical trials for Parkinson's disease patients in Korea. As of the end of September, the drug was administered to 61 patients...Despite the coronavirus outbreak, the recruitment of 99 patients is expected to be completed by the end of this year, and it will be used as funds for rapid termination of phase 2 and global commercialization clinical trials."

Enrollment status • Financing • CNS Disorders • Parkinson's Disease

Peptron (21,100 0.00%) announced on the 28th that recruitment of patients for phase 2 clinical trials of 'PT320', a new treatment for Parkinson's disease , is proceeding smoothly. [Google translation] (The Korea Economic Daily) - "Peptron (21,100 0.00%) announced on the 28th that recruitment of patients for phase 2 clinical trials of 'PT320', a new treatment for Parkinson's disease , is proceeding smoothly....To date, 80% of patients have been screened. The medication was started in 61 patients (62%)....'We expect to complete the recruitment of all clinical patients by the end of the year.'"

Enrollment status • Trial status • CNS Disorders • Parkinson's Disease

Peptron, persistent GLP-1 'Relieves preclinical Parkinson's disease LID' [Google translation] (Biospectator) - "Peptron...announced on the 14th that it has confirmed the efficacy of levodopa side effects LID (Levodopa-Induced Dyskinesia) progression of the persistent GLP-1 drug 'PT320' in a preclinical animal model (6-OHDA)....Peptron announced that it has completed an application for a Pre-IND meeting with the US Food and Drug Administration (FDA) to promote the phase 2 clinical trial of PT320, which has been confirmed to reduce side effects of levodopa."

FDA event • Preclinical • CNS Disorders • Parkinson's Disease

Peptron, first dose of clinical treatment for Parkinson’s disease…Full-scale clinical trial 2 [Google translation] (Maekyung Media Group) - "The clinical trial of Parkinson's disease drugs being developed by peptron has entered the main track. Peptron, a company that specializes in R & D for drug-sustainable drugs, announced that the first dose was administered to patients selected for clinical trials on the 19th, while the recruitment of clinical patients for the treatment of Parkinson's disease 'PT320', which is currently in Phase 2 clinical trials, continues to be smooth."

Enrollment status • Trial status

Peptron's Parkinson's disease treatment blocks levodopa side effects (Korea Biomedical Review) - "Peptron said it has confirmed that PT320, a Parkinson's disease treatment, blocks side effects caused by levodopa, a conventional treatment for Parkinson's....'The drug was found to have the effect of inhibiting the progression of dyskinesia by more than 80 percent compared to the control group in an animal experiment conducted by Motac, a U.K. research firm,' the company said. 'We have subsequently filed for a U.S. patent, which will further strengthen the company's patent portfolio'...'PT320 has proved to prevent neurotoxic side effects of levodopa, and our company expects that combination therapy of the two will have a great effect.'"

Patent • Preclinical

Ministry OKs Peptron’s P2 clinical trial of Parkinson’s disease treatment (Korea Biomedical Review) - "Peptron said Monday that the Ministry of Food and Drug Safety has approved its revised phase 2 clinical trial plans of PT320, a Parkinson’s disease treatment candidate...Under the changed plan, the company will produce the candidate at its Osong plant, which received GMP approval from the ministry on Thursday...company expects to complete the trial by 2020..."

New P2 trial