NYX-2925 / Aptinyx - LARVOL DELTA

New advances in small molecule drugs targeting NMDA receptors. (PubMed, Acta Pharmacol Sin) - "Among various therapeutic indications, depression has emerged as an especially active area of investigation, with mechanistically diverse compounds ranging from broad-spectrum channel blockers (ketamine, dextromethorphan, esmethadone) to glycine site modulators (rapastinel, 4-chlorokynurenine, D-cycloserine) and allosteric modulators (apimostinel, zelquistinel), progressing through clinical pipelines. Beyond depression, NMDA receptor-targeted drug discovery is also advancing in other challenging CNS disorders, including neurodegenerative diseases (salzanemdor, NYX-458), pain (NYX-2925), epilepsy (radiprodil), and stroke (nelonemdaz, NP10679). Collectively, these developments reflect the maturation of NMDA receptor pharmacology and reaffirm the broad therapeutic potential of NMDA receptor modulation, while highlighting promising directions for future drug discovery."

Journal • Review • Cardiovascular • CNS Disorders • Depression • Epilepsy • Mental Retardation • Pain • Psychiatry

What is the progress of experimental drug development for fibromyalgia? (PubMed, Expert Opin Investig Drugs) - No abstract available

Journal • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

NYX-2925 is a novel NMDAR PAM which augments NMDAR-mediated activity in hypo-functioning circuits (Neuroscience 2022) - P2 | "These findings lend support to the hypothesis that NYX-2925 selectively increases NMDAR-mediated activity only at hypoactive synapses. This novel therapeutic mechanism has the potential to augment abnormal NMDAR activity and restore normal circuit function in conditions like fibromyalgia without the risk of adverse effects due to NMDAR overactivation."

CNS Disorders • Musculoskeletal Pain • Pain • GRIN2A

Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia (clinicaltrials.gov) - P2 | N=305 | Completed | Sponsor: Aptinyx | Active, not recruiting ➔ Completed

Trial completion • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN) (clinicaltrials.gov) - P2 | N=229 | Completed | Sponsor: Aptinyx | Active, not recruiting ➔ Completed | Trial completion date: Jun 2022 ➔ Feb 2022 | Trial primary completion date: Jun 2022 ➔ Feb 2022

Trial completion • Trial completion date • Trial primary completion date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Aptinyx Reports First Quarter 2022 Financial Results and Highlights Recent Clinical Progress (Businesswire) - "Aptinyx Inc...today reported financial results for the first quarter of 2022 and highlighted recent progress across the company’s pipeline of novel, clinical-stage, NMDA receptor modulators....The company does not intend to dedicate additional resources to the development of NYX-2925 for painful DPN."

Discontinued • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

NYX-2925, a novel N-methyl-D-aspartate Receptor Positive Allosteric-Modulator, showed antinociceptive Activity in functional Neuroimaging evaluations correlated with improved Patient reported Pain and Fibromyalgia Symptoms (AAN 2022) - "Although these data were presented previously (Harte et al., 2019), they support further understanding of the role of NMDAR-hypofunction and restoration of circuitry integral to pain perception in treating chronic pain conditions like fibromyalgia. A Phase 2b double-blind, placebo-controlled study of 300 patients evaluating the safety and efficacy of NYX-2925 in fibromyalgia is ongoing."

Clinical • Diabetic Neuropathy • Fatigue • Fibromyalgia • Musculoskeletal Pain • Pain • Peripheral Neuropathic Pain • Rheumatology

Aptinyx Reports Results from Phase 2b Study of NYX-2925 in Painful Diabetic Peripheral Neuropathy (Businesswire) - P2b | N=229 | NCT04146896 | Sponsor: Aptinyx | "Aptinyx Inc...announced results from a Phase 2b clinical study evaluating the effects of NYX-2925 in patients with painful diabetic peripheral neuropathy (DPN). NYX-2925 did not achieve statistically significant separation from placebo on the study’s primary endpoint, which assessed the change from baseline in average daily pain on the numeric rating scale (NRS) during week 12....The primary endpoint of the study was not achieved. Patients receiving NYX-2925 showed an improvement in average daily pain scores, but separation from placebo was not observed. Separation between NYX-2925 and placebo was also not observed on the other pain endpoints. NYX-2925 was well tolerated in the study, with no concerning safety issues observed. Detailed data from the study continue to be evaluated."

P2b data • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Aptinyx Reports Fourth Quarter and Full Year 2021 Results and Highlights (Businesswire) - "Aptinyx Inc...today reported financial results for the fourth quarter and full year 2021 and provided updates across the company’s pipeline of novel NMDA receptor modulators....2022 Upcoming Milestones: Data readout from Phase 2b study of NYX-2925 in patients with painful DPN – April 2022...Data readout from Phase 2b study of NYX-2925 in patients with fibromyalgia – early to mid 3Q 2022...Data readout from exploratory Phase 2 study of NYX-458 in cognitive impairment – late 2022 or 1Q 2023..."

P2 data • P2b data • CNS Disorders • Cognitive Disorders • Diabetic Neuropathy • Fibromyalgia • Neuralgia • Pain • Parkinson's Disease • Peripheral Neuropathic Pain

Aptinyx Highlights Key Goals and Anticipated Development Milestones for 2022 (Businesswire) - "Aptinyx Inc. today provided a corporate update and highlighted development milestones anticipated in 2022....NYX-2925 for chronic pain – Phase 2b readouts expected in 2Q and mid-year 2022....The company’s Phase 2b study of NYX-2925 in 300 patients with fibromyalgia is on track to report results in mid 2022....NYX-458 for cognitive impairment – Phase 2 readout expected in 2H 2022....Enrollment is progressing in an exploratory Phase 2 study of NYX-458 in 100 patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies. The company anticipates reporting data from the study in the second half of 2022."

Enrollment status • P2 data • P2b data • CNS Disorders • Fibromyalgia • Musculoskeletal Pain • Pain • Parkinson's Disease

Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia (clinicaltrials.gov) - P2 | N=305 | Active, not recruiting | Sponsor: Aptinyx | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Aptinyx Completes Enrollment in Phase 2b Study of NYX-2925 in Fibromyalgia (Businesswire) - "Aptinyx Inc...today announced the completion of enrollment of 305 patients in the company’s ongoing Phase 2b study of NYX-2925 in fibromyalgia. Patients recently enrolled in the study are completing the 12-week treatment period and 30-day safety follow-up period. The company expects to report results from the study in early to mid 3Q 2022."

Enrollment closed • P2b data • CNS Disorders • Fibromyalgia • Musculoskeletal Pain • Pain

"$APTX Aptinyx Completes Enrollment in Phase 2b Study of NYX-2925 in Fibromyalgia https://t.co/VzbGwpaTLj" (@stock_titan)

Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Aptinyx Hosts Virtual Portfolio Review Event to Showcase NYX-2925 in Chronic Pain and Provide Update on Clinical Development Programs (Businesswire) - "Aptinyx Inc...will host a virtual portfolio review event today beginning at 10:00 a.m. ET. Presented in a live webcast format, the company will discuss its approach to the development of novel NMDA receptor modulators and review its pipeline of four clinical development programs, with particular focus on NYX-2925 in chronic pain....Aptinyx expects to report data from the Phase 2b painful DPN study in April or early May and anticipates reporting data from the Phase 2b fibromyalgia study in mid-2022....NYX-458 is currently under evaluation in an exploratory Phase 2 study in patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies. The company expects to report data from this study in 4Q 2022 or 1Q 2023."

Clinical • P2 data • P2b data • CNS Disorders • Cognitive Disorders • Diabetic Neuropathy • Fibromyalgia • Musculoskeletal Pain • Neuralgia • Pain • Parkinson's Disease • Peripheral Neuropathic Pain

Aptinyx Reports Third Quarter 2021 Financial Results and Recent Highlights (Businesswire) - “Clinical study enrollment updates: In October, the company announced the completion of enrollment in the company’s ongoing Phase 2b study of NYX-2925 for the treatment of painful diabetic peripheral neuropathy (DPN)…and the company expects to report results from the study in early to mid 2Q 2022….Enrollment progressing in Phase 2b study of NYX-2925 in patients with fibromyalgia – The study is expected to read out in mid 2022. Enrollment progressing in exploratory Phase 2 study of NYX-458 in patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies –The study is expected to read out in 2H 2022….Research and development expenses were $16.3 million for the three months ended September 30, 2021...The increase in R&D expenses was primarily driven by costs associated with enrollment activities in the company’s two ongoing Phase 2b studies of NYX-2925 in chronic pain.”

Commercial • P2 data • CNS Disorders • Cognitive Disorders • Diabetic Neuropathy • Fibromyalgia • Neuralgia • Pain • Parkinson's Disease • Peripheral Neuropathic Pain

Aptinyx Completes Enrollment in Phase 2b Study of NYX-2925 in Painful Diabetic Peripheral Neuropathy (Businesswire) - “Aptinyx Inc…announced the completion of enrollment in the company’s ongoing Phase 2b study of NYX-2925 for the treatment of painful diabetic peripheral neuropathy (DPN). Patients recently enrolled in the study are completing the 12-week treatment period and 30-day safety follow-up period. The company expects to report results from the study in early to mid 2Q 2022.”

Enrollment closed • P2 data • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN) (clinicaltrials.gov) - P2; N=229; Active, not recruiting; Sponsor: Aptinyx; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Aptinyx Announces Publication of Review Article Highlighting Preclinical Data in Medicine in Drug Discovery Demonstrating the Potential of NYX-2925 to Treat Chronic, Centralized Pain Conditions (Businesswire) - "Aptinyx...today announced the publication of a recent review article in Medicine in Drug Discovery featuring data on its novel NMDA receptor modulator, NYX-2925. The data span across numerous preclinical models and highlight the potential therapeutic benefits of NYX-2925 in treating chronic, centralized pain conditions...Given all of the compelling evidence we have gathered to date with NYX-2925, we are eager to complete the two ongoing Phase 2b studies in the first half of 2022 and to move closer to our goal of bringing NYX-2925 to patients in need of better therapeutic options."

Preclinical • Review • Trial completion date • CNS Disorders • Pain

Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN) (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Aptinyx; Active, not recruiting ➔ Recruiting; Trial completion date: Nov 2020 ➔ Jun 2022; Trial primary completion date: Nov 2020 ➔ Jun 2022

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Aptinyx Announces Recommencement of Phase 2 Study of NYX-2925 in Patients With Painful Diabetic Peripheral Neuropathy (Businesswire) - "Aptinyx...today announced that in December it recommenced patient recruitment and screening in a Phase 2 study of NYX-2925 in patients with painful diabetic peripheral neuropathy (DPN)...'This study in painful DPN represents the second ongoing Phase 2 study of NYX-2925 in chronic pain...and we expect to read out data from each of these studies in the first half of 2022.'"

Enrollment status • P2 data • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Aptinyx Reports Third Quarter 2020 Financial Results and Recent Highlights (Businesswire) - "Strengthened the company’s financial position through the completion of a $48.3 million common stock offering....The company’s current cash balance, inclusive of the net proceeds from the offering, is expected to provide financial support into 2023 and enable completion of multiple ongoing Phase 2 clinical studies. Expected Upcoming Milestones: Recommencement of Phase 2b clinical study of NYX-2925 in patients with painful diabetic peripheral neuropathy – 4Q 2020; Recommencement of Phase 2 exploratory clinical study of NYX-458 in patients with cognitive impairment associated with Parkinson’s disease – 1Q 2021;...Reporting of data from Phase 2b clinical study of NYX-2925 in patients with fibromyalgia – 1H 2022; Reporting of data from Phase 2b clinical study of NYX-2925 in patients with painful DPN – 1H 2022."

Financing • P2b data • Trial initiation date • CNS Disorders • Fibromyalgia • Musculoskeletal Pain • Neuralgia • Pain • Parkinson's Disease • Peripheral Neuropathic Pain

Aptinyx posts phase 2 PTSD win nearly 2 years after diabetes pain flop (FierceBiotech) - "Aptinyx is still chugging along with NYX-2925. It recently restarted enrolling patients in a phase 2 trial testing it as a treatment for pain in patients with fibromyalgia. It expects to report top-line data in early 2022....'Coupled with the positive evidence of biological activity relevant to central pain processing from our recently announced interim analysis of a fibromyalgia study, we believe the total body of clinical data indicates the potential of NYX-2925 to treat chronic pain. We will continue to interrogate the full dataset to determine the most appropriate path forward for NYX-2925 in development for chronic pain...'"

P2 data • CNS Disorders • Fibromyalgia • Neuralgia • Pain • Peripheral Neuropathic Pain

Aptinyx Announces Pricing of Public Offering of Common Stock (Businesswire) - "Aptinyx Inc....today announced the pricing of its public offering of 14,000,000 shares of its common stock at a public offering price of $3.00 per share....Aptinyx intends to use the net proceeds received from the offering to advance the development of its novel NMDA receptor modulators, including NYX-2925, NYX-783, and NYX-458, in development for chronic pain, PTSD, and cognitive impairment, respectively, and for working capital and other general corporate purposes."

Financing • CNS Disorders • Fibromyalgia • Musculoskeletal Pain • Neuralgia • Pain • Parkinson's Disease • Peripheral Neuropathic Pain • Post-traumatic Stress Disorder

Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia (clinicaltrials.gov) - P2; N=300; Recruiting; Sponsor: Aptinyx; Active, not recruiting ➔ Recruiting; Trial completion date: Feb 2021 ➔ Jun 2022; Trial primary completion date: Feb 2021 ➔ Jun 2022

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Aptinyx Recommences Patient Recruitment in Phase 2 Study of NYX-2925 in Patients with Fibromyalgia (Businesswire) - "Aptinyx Inc....today announced that it has re-activated study sites and recommenced patient recruitment in a Phase 2 study of NYX-2925 in patients with fibromyalgia. Enrollment in the study had been suspended in March 2020 due to the escalation of the COVID-19 pandemic in the United States....'We will be watching the pace of enrollment closely in the coming months to inform timeline expectations, but currently expect to report data from this study in the first half of 2022; Also on track to recommence separate Phase 2 study of NYX-2925 in painful DPN in 4Q 2020."

Enrollment status • P2 data • Trial status • Musculoskeletal Pain • Neuralgia • Pain • Peripheral Neuropathic Pain