Accordion Pill carbidopa/levodopa CR (carbidopa/levodopa CR) / Jazz, Indaptus Therap - LARVOL DELTA

Continuous subcutaneous apomorphine infusion reduces motor fluctuations in PD (Healio) - "Lead study author Stuart H. Isaacson, MD, and colleagues sought to evaluate long-term safety and efficacy of continuous subcutaneous apomorphine infusion (CSAI) for those with motor fluctuations in PD treated in the United States, as the treatment has been used in Europe for nearly three decades and confirmed by the TOLEDO open-label extension study."

Form S-1 Indaptus Therapeutics (Streetinsider.com) - "On August 3, 2021, Indaptus completed its merger with Decoy Biosystems, Inc....In connection with the completion of the Merger, on August 4, 2021, our board determined to wind down the Accordion Pill business of Intec Israel. We expect that the winding down of the Accordion Pill business will be completed by the end of 2021."

Commercial • M&A • CNS Disorders • Parkinson's Disease

An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease Studio di fase II in aperto volto a valutare la farmacocinetica di Accordion Pill¿ carbidopa/levodopa rispetto a carbidopa/levodopa a rilascio immediato in pazienti affetti da malattia di Parkinson (clinicaltrialsregister.eu) - P2; N=12; Completed; Sponsor: INTEC PHARMA LTD

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Accordion Pill: Expiry of patent related to dosage forms in US in 2029 (22nd Annual H.C. Wainwright Global Investment Conference 2020 (Virtual Meeting), Intec Pharma) - Expiry of patent related to methods for making/folding gastro-retentive drug delivery system in US in 2028; Protection of patent related to CD/LD as active ingredient in US in 2029; Expiry of patent related to treatment of PD symptoms in US in 2031

Patent • CNS Disorders • Parkinson's Disease

Accordion Pill: Expiry of patent related to dosage forms in US in 2029 (22nd Annual H.C. Wainwright Global Investment Conference 2020 (Virtual Meeting), Intec Pharma) - Expiry of patent related to methods for making/folding gastro-retentive drug delivery system in US in 2028; Protection of patent related to CD/LD as active ingredient in US in 2029; Expiry of patent related to treatment of PD symptoms in US in 2031

Patent • CNS Disorders • Parkinson's Disease

Pharmacokinetics and efficacy of a novel formulation of carbidopa-levodopa (Accordion Pill) in Parkinson's disease. (PubMed, Parkinsonism Relat Disord) - "AP technology demonstrated effective controlled-release PK performance and reduced motor response fluctuations in advanced PD patients. A phase 3 randomized controlled trial is currently underway."

Clinical • Journal • PK/PD data • CNS Disorders • Gene Therapies • Movement Disorders • Parkinson's Disease

Safinamide in the management of patients with Parkinson’s disease not stabilized on levodopa: A review of the current clinical evidence (Dovepress) - "Evidence suggests that safinamide is a good option for add-on therapy to carbidopa/levodopa in patients with advanced PD with motor complications, but there is still insufficient evidence to recommend it as monotherapy or add-on therapy in patients with early PD."

Review • CNS Disorders • Parkinson's Disease

Prions, the pipeline, and the latest in Parkinson disease (Medscape) - "The Canadian company Cynapsus Therapeutics is developing a sublingual formulation of apomorphine (a dopamine agonist), and IntecPharma is implementing an accordion pill of levodopa/carbidopa that would release the drug for about 8 hours and allow more controlled absorption by the duodenum. Finally, both Impax Rytary® and AbbVie Duopa® (levodopa /carbidopa intestinal gel) are now available in the United States....AFFiRiS is waiting to see the results from PD03A and the exploratory data on the antibody response for this compound before selecting the best candidate to test in a phase 2 clinical trial (efficacy)."

Launch US • Pipeline update • Parkinson's Disease

Pint-sized biotechs join the IPO queue as Wall Street cash pours in (FierceBiotech) - "Intec plans to advance its 'accordion pill' technology, a drug delivery system the company says can improve the efficacy of existing drugs by increasing the time they spend in the stomach. The biotech's top prospect is an accordion-enabled take on the standard Parkinson's drugs carbidopa and levodopa, slated to enter Phase III in the second half, followed by a Phase II treatment for insomnia."

Anticipated new P3 trial • Parkinson's Disease

Intec Pharma Ltd. announces partial exercise of underwriters option to purchase additional ordinary shares (Market Watch) - "The Company plans to use the net proceeds from the offering to fund its Phase III clinical trial for its current product candidate, Accordion Pill Carbidopa/Levodopa, and its continued development, and for working capital, capital expenditures and other general corporate purposes..."

Financing • Parkinson's Disease

Intec Pharma completes enrollment of pivotal phase 3 clinical trial of Accordion Pill carbidopa/levodopa for the treatment of advanced Parkinson's disease patients (PRNewswire) - P3, N=420; ACCORDANCE (NCT02605434); Sponsor: Intec Pharma; "Intec Pharma...today announces the completion of patient enrollment in the Company's pivotal Phase 3 clinical trial (the ACCORDANCE trial) evaluating the safety and efficacy of Accordion Pill™-Carbidopa/Levodopa (AP-CD/LD) compared with immediate release CD/LD (IR-CD/LD; Sinemet®) as a treatment for the symptoms of advanced Parkinson's disease...The study is being conducted at approximately 90 clinical sites throughout the U.S., Europe and Israel...On Track to Report Topline Data in Mid-2019 for Potential New Baseline Levodopa Treatment."

Enrollment status • P3 data: top line • CNS Disorders • Parkinson's Disease

Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients (clinicaltrials.gov) - P2; N=12; Not yet recruiting; Sponsor: Intec Pharma Ltd.

New P2 trial • Biosimilar • CNS Disorders • Gene Therapies • Genetic Disorders • Parkinson's Disease

Intec Pharma reports first quarter 2020 financial results and provides corporate update (PRNewswire) - "Announced that the Accordion Pill (AP) developed for a Merck & Co. (MSD) proprietary compound met the in vitro specifications set forth in the companies' research collaboration and the Company is now in discussions with MSD regarding advancing the program into the clinic; Initiated AP-Carbidopa/Levodopa (AP CD/LD) commercial manufacturing stability lots with LTS Lohmann Therapie-Systeme AG (LTS)....'We continue our discussions with Merck with an aim to advance that program into human pharmacokinetic (PK) trials'....A decrease of $6.5 million....The decrease was primarily due to the ACCORDANCE study and Open Label Extension study, both of which were completed during 2019..."

Commercial • New trial • CNS Disorders • Parkinson's Disease

AP-CD/LD: Initiate PK studies with thrice daily dosing for Parkinson’s disease in H2 2018 (Jefferies 2018 Global Healthcare Conference, Intec Pharma)

New trial • CNS Disorders • Parkinson's Disease

AP-CD/LD: Initiate PK studies with thrice daily dosing for Parkinson’s disease in H2 2018 (Jefferies 2018 Global Healthcare Conference, Intec Pharma)

New trial • CNS Disorders • Parkinson's Disease

Intec Pharma publishes letter to shareholders (PRNewswire) - "The Phase 2 pharmacokinetic (PK) study of AP-CD/LD 50/500 mg dosed three times per day (TID)...Blood samples from the study are scheduled to be batch analyzed at the PK laboratory in Italy during January 2019...During 2019, we plan to begin the validation, bridging and stability studies needed for regulatory filing and expect these should put us on track for a submission with the U.S. Food and Drug Administration (FDA) in mid-to-late 2020."

Clinical • NDA • CNS Disorders • Parkinson's Disease

Intec Pharma reports fourth quarter and year end 2017 financial results and business update (PRNewswire) - P3, N=300; NCT02605434; "The Company believes enrollment will be completed some time in the second half of 2018....A new pharmacokinetic (PK) study to determine the performance of the pill used in the Phase 3 Parkinson's study when dosed three time per day (TID) is being planned....The Company expects that these results will be available in the second half of 2018."

Enrollment status • PK/PD data • CNS Disorders • Parkinson's Disease

Intec Pharma reports first quarter 2018 financial results and corporate update (PRNewswire) - P3, N=420; NCT02605434; " 'We are especially pleased by the developments in our Phase 3 program of AP-CD/LD as a treatment for advanced Parkinson's disease. To date, we have enrolled more than 350 patients and remain on track to complete enrollment of this pivotal trial later this year, with top-line results expected in mid-2019....In addition, we are nearing initiation of a pharmacokinetic (PK) study of the 500 mg AP-CD/LD three times a day (TID) dose in order to demonstrate the PK profile of LD provided by AP-CD/LD."

Enrollment status • P3 data: top line • Trial initiation date • CNS Disorders • Parkinson's Disease

AP-CDLD: “More stable LD plasma levels: Peak to trough ratio was reduced from 29.9 to 3.2 with AP-CDLD” (Jefferies 2017 Global Healthcare Conference, Intec Pharma) - "Significantly reduced motor complications"; "Significantly reduced number of LD administrations per day"

P2 data • CNS Disorders • Parkinson's Disease

AP-CDLD: “More stable LD plasma levels: Peak to trough ratio was reduced from 29.9 to 3.2 with AP-CDLD” (Jefferies 2017 Global Healthcare Conference, Intec Pharma) - "Significantly reduced motor complications"; "Significantly reduced number of LD administrations per day"

P2 data • CNS Disorders • Parkinson's Disease

AP-CD/LD: "Apparent half‑life (t1/2)was increased from 1.8 h with IR‑CD/LD to 5.2 h with AP‑CD/LD, while Cmax was decreased from 4,062 ng/mL to 1,951 ng/mL" (Intec Pharma) - AAN 2018: "LD absorption was prolonged from ~2 h with IR‑CD/LD to ~10 h with AP‑CD/LD"

PK/PD data • CNS Disorders • Parkinson's Disease

Intec Pharma granted patent in Canada for Accordion Pill carbidopa / levodopa (PRNewswire) - "Intec Pharma Ltd....today announced that the Canadian Intellectual Property Office has issued a Certificate of Grant of a Canadian patent...The patent, entitled 'Carbidopa/Levodopa Gastroretentive Drug Delivery,' broadly covers the Accordion Pill containing certain drugs, including the combination of Carbidopa and Levodopa and provides patent protection through April 2029."

Patent • CNS Disorders • Parkinson's Disease

The Accordion Pill: unique oral delivery to enhance pharmacokinetics and therapeutic benefit of challenging drugs. (PubMed, Ther Deliv) - "AP provides a novel treatment platform for improving PK and efficacy for drugs with narrow absorption windows or poor solubility. Furthermore, AP allows multiple drug release profiles in a single capsule and can provide fixed-dose combinations."

Journal • PK/PD data

Accordion Pill: Expiry of patents related to dosage forms in US, Israel, Japan, Australia, Canada, South Africa, the United Kingdom and EU in November 2020 (Intec Pharma) - Annual Report 2019: Expiry of patents related to methods for making/folding gastroretentive drug delivery system in 2027, US in 2028; Protection of patents related to CD/LD as active ingredient in US until April 17, 2029; Expiry of patents related to treatment of PD symptoms in US, Canada, EU, India and Israel until November 2031

Patent

Intec Pharma reports third quarter 2019 financial results and provides business update (PRNewswire) - "Intec Pharma...today announces financial results for the three and nine months ended September 30, 2019...Completed the qualification studies for the commercial scale manufacture of AP-CD/LD with our partner, LTS LohmanTherapie-Systeme..."

Trial completion