ifenprodil (NP-120) / Seyltx - LARVOL DELTA

Seyltx Announces Positive Pre-Clinical Dose-Ranging Data with Its Selective Oral Small-Molecule Inhibitor of GluN2B Illustrating Near-Complete Suppression of Refractory Chronic Cough within the Therapeutic Index (GlobeNewswire) - "Seyltx, Inc...announced positive pre-clinical data describing near-complete cough suppression in a dose-dependent manner below the no observed adverse effect level dose ('NOAEL'). Based on this data, the Company unveiled details and timing of the SILINDA Phase 2b program for its highly selective GluN2B allosteric antagonist product candidate for the treatment of RCC....'We are now well positioned to execute our SILINDA Phase 2b program, and we look forward enrolling our first patient in 2025'....Topline data from SILINDA are expected approximately at the end of 2026."

New P2b trial • P2b data • Preclinical • Chronic Cough • Cough

Seyltx Announces Results of Electronic Health Record Analysis to Determine the Prevalence of Refractory Chronic Cough (GlobeNewswire) - "The analysis indicates 2.19% of the adult population suffers from refractory chronic cough....Seyltx...today announced the results of a study performed that analyzed real world electronic health record ('EHR') data to determine the prevalence of refractory chronic cough ('RCC') in the adult population. Based on this data, the Company believes that it can optimize enrollment in its Phase 2b clinical trial and more accurately model the commercial opportunity for a product candidate....The Company’s preclinical data with its product candidate, ifenprodil, illustrates significant antitussive effects at doses well below the no observed adverse event limit ('NOAEL'). The completed Phase 2a clinical trial recapitulates and extends upon the preclinical data by illustrating statistically significant reductions in geometric mean cough count reduction. The Company plans to dose the first patients in its Phase 2b clinical trial in early 2025."

Clinical data • Preclinical • Trial status • Chronic Cough

Algernon Pharmaceuticals Announces Closing of the Acquisition of its Chronic Cough Research Program by U.S. Based Seyltx for USD $2M and a 20% Equity Position (GlobeNewswire) - "Algernon Pharmaceuticals Inc...is pleased to announce that it has closed on its agreement with Seyltx Inc...acquisition of Algernon’s NP-120 ('Ifenprodil') research program for the purchase price of USD $2M cash and a 20% common share equity position in Seyltx. The Company previously announced on November 22, 2023 that it had signed a Letter of Intent with Seyltx, to acquire Algernon’s Ifenprodil research program...Seyltx plans to initiate an Ifenprodil multi-center Phase 2b placebo-controlled chronic cough study in CY2024. Algernon’s clinical management team will be available to provide support, oversight, and management of the study....In connection with the transaction, Maxim Group LLC was paid a transaction advisory services fee pursuant to an agreement with Algernon whereby Maxim was retained to identify and evaluate potential M&A and strategic opportunities."

Licensing / partnership • New P2b trial • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

Algernon Pharmaceuticals Announces Notice of Allowance for Ifenprodil Patent in Japan for Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "Algernon Pharmaceuticals Inc...is pleased to announce that it has received a notice of allowance from the Japanese Patent Office for patent application No. 2021-547495 entitled: Compositions and Methods for Treating Idiopathic Pulmonary Fibrosis (IPF). The Company was previously granted a patent for the treatment of IPF in Canada and has also filed corresponding patent applications in the U.S., Europe, and China....'The invention claims treating interstitial lung disease, including idiopathic pulmonary fibrosis, with ifenprodil.'"

Patent • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

Algernon Pharmaceuticals Announces LOI for the Acquisition of its Chronic Cough Research Program by U.S. Based Seyltx for USD $2M and a 20% Equity Position (GlobeNewswire) - "Algernon Pharmaceuticals Inc...is pleased to announce that it has signed a Letter of Intent ('LOI') with Seyltx Inc. ('Seyltx'), a privately owned U.S. based drug development company, to acquire Algernon’s NP-120 ('Ifenprodil') research program for USD $2M cash and a 20% common share equity position in Seyltx. The transaction is subject to certain conditions including, inter alia, Seyltx financing and the negotiation and execution of a definitive agreement, which is expected to occur within the next 90 days. Seyltx plans to conduct an Ifenprodil Phase 2b chronic cough study as soon as possible."

Licensing / partnership • Chronic Cough

Algernon Pharmaceuticals Engages Maxim Group to Explore Spin-Off of its Ifenprodil Phase 2 Chronic Cough Drug Development Program (GlobeNewswire) - "Algernon Pharmaceuticals Inc...is pleased to announce that it has engaged Maxim Group LLC ('Maxim') to provide financial advisory and investment banking services, and to assist in identifying and evaluating potential M&A and strategic opportunities, including the potential spin-off of the Company's NP-120 ('Ifenprodil') chronic cough research program...The decision to advance to a Phase 2b cough study was based on positive data previously reported from the Company’s proof of concept Phase 2a study of idiopathic pulmonary fibrosis ('IPF') and chronic cough on July 28, 2022..."

Licensing / partnership • New P2b trial • Chronic Cough • Cough • Immunology • Respiratory Diseases

Algernon Pharmaceuticals to Present Phase 2 Ifenprodil Cough Data at the 2023 American Cough Conference (GlobeNewswire) - "Algernon Pharmaceuticals Inc...pleased to announce that it will present its Phase 2a Ifenprodil cough data at the 9th American Cough Conference (ACC) being held June 9-10, 2023 in Reston, Virginia....Christopher Bryan, PhD, Vice President of Research and Operations at Algernon Pharmaceuticals, will present...during a thematic oral session on antitussive drug development programs. The focus of the talk will be on data from AGN-120-1, the Company’s Phase 2a clinical trial in Idiopathic Pulmonary Fibrosis (IPF) and associated cough."

P2a data • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

Algernon Pharmaceuticals Announces Plans for a 180 Patient Phase 2b Chronic Cough Study of Ifenprodil (GlobeNewswire) - "Algernon Pharmaceuticals Inc...is pleased to announce that it is planning a 180 patient, 90-day Phase 2b clinical study of NP-120 ('Ifenprodil') for chronic cough to begin in Q3 of 2023....The planned study design will include the following elements: Multinational, three-arm, randomized, double-blind, placebo-controlled trial to evaluate NP-120 in approximately 180 patients. Patients will be randomized 1:1:1 to receive NP-120 (20mg TID) or NP-120 (40mg TID), or placebo for 12 weeks. The primary endpoint will be the reduction in geometric mean 24-hr cough count over 12 weeks compared to placebo. Secondary endpoints will include safety, tolerability and patient-reported quality-of-life measures."

New P2b trial • Chronic Cough • Cough

Algernon Pharmaceuticals Forms Private Subsidiary to Advance Company’s Psychedelic DMT Stroke Program; Files Form 1-A Offering Statement with U.S. SEC for Regulation A+ Offering (GlobeNewswire) - "Algernon Pharma will provide an update on the Company’s plans for 2023 for Ifenprodil and its IPF and Chronic cough research program shortly."

Pipeline update • Cough • Idiopathic Pulmonary Fibrosis

Algernon Pharma inks equity distribution agreement to raise aggregate gross proceeds of up to $5.0M (Proactiveinvestors) - “Algernon Pharmaceuticals Inc…said it has entered into an equity distribution agreement dated December 23, 2022, with Research Capital Corp for the at-the-market (ATM) offering of its common shares….The company said it intends to use the net proceeds of the ATM offering to complete the…formulation and manufacturing of the finished drug product for the phase 2b study of Ifenprodil in chronic cough, and for general and administrative purposes.”

Licensing / partnership • Chronic Cough • Cough • Respiratory Diseases

Algernon Pharmaceuticals Receives U.S. FDA Orphan Drug Designation for Ifenprodil for the Treatment of Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "Algernon Pharmaceuticals Inc...pleased to announce that the United States Food and Drug Administration ('U.S. FDA') has granted Orphan Drug Designation (ODD) to Ifenprodil as a treatment for Idiopathic Pulmonary Fibrosis (IPF)."

Orphan drug • Cough • Idiopathic Pulmonary Fibrosis

An open label study of the efficacy, safety and tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and its associated cough (ICLAF 2022) - P2 | "NP-120 (Ifenprodil), an NMDA-receptor antagonist used in Japan in the treatment of vertigo, has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a murine model of IPF...Subjects receiving treatment with Nintedanib or Pirfenidone were also eligible provided treatment was deemed stable before enrolment... Primary outcome measures for the trial are 12-week changes in forced vital capacity and changes in cough count. In addition, the effects on biomarkers of fibrosis (proC3, C3M, proC5, C5M, proC6, C6M and reC1M), DLCO, the mmRC dyspnea scale, VAS cough severity score, K-BILD questionnaire, Leicester Cough Questionnaire, and Global Rating of Change Scale Questionnaire will be presented, along with safety outcomes."

Clinical • Cough • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Vertigo • PRO-C3

Algernon Pharmaceuticals Files for Orphan Designation with the U.S. FDA for Ifenprodil as a Treatment of IPF (GlobeNewswire) - "Algernon Pharmaceuticals...announce that it has decided to advance its investigation of NP-120 (Ifenprodil) for IPF with cough as its key indication. As a result, the Company further announces it has filed a request for Orphan Designation with the United States Food and Drug Administration ('U.S. FDA') for the use of Ifenprodil as a treatment for IPF."

Orphan drug • Cough • Idiopathic Pulmonary Fibrosis

Algernon Pharmaceuticals Reports Positive Results from Full Data Set of its Phase 2 Study of Ifenprodil for IPF and Chronic Cough (GlobeNewswire) - P2a | N=20 | NCT04318704 | Sponsor: Algernon Pharmaceuticals | “Algernon Pharmaceuticals Inc…is pleased to report positive results from the full data set of its Phase 2a Study evaluating NP-120 (‘Ifenprodil’) for the potential treatment of idiopathic pulmonary fibrosis (‘IPF’) and chronic cough….IPF Data: Secondary endpoints focused on pulmonary fibrosis, as indicated by key measures, were consistent with the preservation of lung function as measured by key indications, specifically; Unchanged diffusing capacity for carbon monoxide (DLCO) over twelve weeks (change from baseline 0.00, p > 0.99, 95% CI -3.14, 3.14)….Cough Data: Secondary endpoints focused on cough showed significant improvements, namely: A reduction of 23.6 mm from baseline in the cough visual analogue scale (VAS) (p = 0.0005, 95% CI -35.22, -11.94)."

P2a data • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis

Algernon Pharmaceuticals Invited to Present Phase 2 IPF and Chronic Cough Study Data at 9th American Cough Conference (GlobeNewswire) - "Algernon Pharmaceuticals...is pleased to announce it has been invited to present the results from its Phase 2a Study of NP-120 ('Ifenprodil') for idiopathic pulmonary fibrosis ('IPF') and Chronic Cough, at the 9th American Cough Conference in June, 2023."

P2a data • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis

Algernon Pharmaceuticals Reports Additional Positive Data From its Phase 2 Study of Ifenprodil for IPF and Chronic Cough (GlobeNewswire) - P2 | N=20 | NCT04318704 | Sponsor:Algernon Pharmaceuticals | "Algernon Pharmaceuticals...announce additional results from its Phase 2a Study of NP-120 ('Ifenprodil') for idiopathic pulmonary fibrosis ('IPF') and chronic cough. After further review of the topline data, Ifenprodil was shown to be much more effective at reducing cough in patients than initially reported....The geometric mean 24-hour cough counts were reduced by 32.0% at 4 weeks (p = 0.023) and 39.5% at 12 weeks (p = 0.001) compared to baseline. The geometric mean awake cough counts were reduced by 30.2% at 4 weekas (p = 0.038) and 37.4% at 12 weeks (p = 0.002) compared to baseline."

P2 data • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis

Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Algernon Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Cough • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Algernon Pharmaceuticals Hits Co-Primary Endpoint in its Phase 2 Study of Ifenprodil for Idiopathic Pulmonary Fibrosis and Chronic Cough (GlobeNewswire) - P2 | N=20 | NCT04318704 | Sponsor: Algernon Pharmaceuticals | "Algernon Pharmaceuticals...announce positive topline data showing that it has met the co-primary endpoint in its Phase 2 proof of concept study evaluating NP-120 ('Ifenprodil') for the potential treatment of idiopathic pulmonary fibrosis ('IPF') and chronic cough. In the study, 65% of patients had stable or improved forced vital capacity ('FVC') over the 12-week treatment period with statistical significance when compared to an anticipated placebo effect of 40%....For the chronic cough part of the study’s primary endpoint, 30% of subjects achieved the endpoint of a 50% reduction in the average number of coughs per hour over 24 hours from baseline to week 12....The Company expects to receive the full data set from the study in August 2022 and will present the full results of the study at the 21st International Colloquium on Lung and Airway Fibrosis in Reykjavik, Iceland in October 2022."

P2 data • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis

Algernon Announces Patients Requested Ongoing Supply of Ifenprodil after IPF and Chronic Cough Phase 2 Study Ended (GlobeNewswire) - "Algernon Pharmaceuticals...announces that patients from multiple sites participating in its Phase 2 proof of concept study of NP-120 ('Ifenprodil') for idiopathic pulmonary fibrosis ('IPF') and chronic cough, being conducted in Australia and New Zealand, have requested ongoing supply of Ifenprodil for their personal use beyond the study’s treatment period."

Commercial • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis

Algernon Pharmaceuticals Announces Issuance of Patent for Ifenprodil for the Treatment of Idiopathic Pulmonary Fibrosis (GlobeNewswire) - "Algernon Pharmaceuticals...is pleased to announce that it has been issued a patent from the Canadian Intellectual Property Office ('CIPO'), No. 3101853, for the treatment of interstitial lung disease with NP-120 ('Ifenprodil'), entitled 'Compositions and Methods for Treating Idiopathic Pulmonary Fibrosis.'...The base claims of the patent will be valid through 2038, excluding any patent term adjustments or extensions which may provide additional protection. The Company also has active patent applications for Ifenprodil for the same compositions and methods in the U.S., Europe, China and Japan."

Patent • Idiopathic Pulmonary Fibrosis

Algernon Pharmaceuticals Announces Database Lock in Phase 2 Study of IPF and Chronic Cough (GlobeNewswire) - "Algernon Pharmaceuticals...announce that its Phase 2 proof-of-concept study of NP-120 ('Ifenprodil') for idiopathic pulmonary fibrosis ('IPF') and chronic cough has reached database lock. This means that all data from the trial is now finally reported, cleaned and 'locked' in the database. As previously stated, the Company is projecting that topline data will be available in July, 2022."

P2 data • Trial status • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis

Algernon Pharmaceuticals Announces Last Patient Treated in Phase 2 Study of IPF and Chronic Cough (GlobeNewswire) - "Algernon Pharmaceuticals...announce that the last patient has completed the treatment period in its Phase 2 proof of concept study of NP-120 ('Ifenprodil') for idiopathic pulmonary fibrosis ('IPF') and chronic cough.The Company is projecting that topline data will be available in July 2022....'New treatment options are needed, and I look forward to seeing the results of Algernon’s proof of concept Phase 2 trial.'"

P2 data • Trial status • Chronic Cough • Cough • Idiopathic Pulmonary Fibrosis

Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Algernon Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Cough • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Phase 2 Study of NP-120 for Hard-to-treat Cough Hits Full Enrollment (Pulmonary Fibrosis News) - "Algernon Pharmaceuticals hit the full enrollment of 20 patients with idiopathic pulmonary fibrosis (IPF) in its Phase 2 study of NP-120 (ifenprodil) for persistent, hard-to-treat cough, a common symptom of the disease. Early interim data from the study (NCT04318704), underway in Australia and New Zealand, showed that those given treatments with the investigational oral medication for up to three months (12 weeks) tended to cough less than before. The company now expects to have more data in the second quarter of this year."

Enrollment closed • P2 data • Chronic Cough • Cough

Algernon Pharmaceuticals Announces Completion of Enrollment in its Phase 2 Study of Ifenprodil for IPF and Chronic Cough (GlobeNewswire) - "Algernon Pharmaceuticals Inc...is pleased to announce that it has completed enrollment in its Phase 2 NP-120 ('Ifenprodil') idiopathic pulmonary fibrosis ('IPF') and chronic cough study. The Company is projecting a data readout in calendar Q2, 2022."

Enrollment closed • P2 data • Idiopathic Pulmonary Fibrosis • Respiratory Diseases