Initiated two Phase 2 studies of NYX-2925 in chronic pain conditions
On track to have four Phase 2 studies ongoing by year end across pipeline of CNS product candidates
Conference call today at
“We made significant progress in the third quarter and subsequent period, including the initiation of two Phase 2 studies of NYX-2925 in patients with painful DPN and fibromyalgia,” said
Third Quarter 2019 and Recent Highlights
- Initiated a Phase 2 study of NYX-2925 in patients with painful diabetic peripheral neuropathy. Earlier today,
Aptinyxannounced the initiation of a Phase 2 study evaluating the effects of NYX-2925 in patients with painful diabetic peripheral neuropathy (DPN). The study is evaluating daily oral dosing of NYX-2925 50 mg compared to placebo. The primary endpoint is the change from baseline in average daily pain score over a 12-week period as reported on the 10-point numeric rating scale (NRS). The company expects to report top-line results from this study in late 2020 or early 2021.
- Initiated a Phase 2 study of NYX-2925 in patients with fibromyalgia. Earlier today,
Aptinyxannounced the initiation of a Phase 2 study evaluating the effects of NYX-2925 in patients with fibromyalgia. The study is evaluating daily oral dosing of two dose levels of NYX-2925—50 mg and 100 mg—compared to placebo. The primary endpoint is the change from baseline in average daily pain score over a 12-week period as reported on the 10-point numeric rating scale (NRS). The company expects to report top-line results from this study in the first half of 2021.
- Results of a Phase 2 fibromyalgia study of NYX-2925 were selected for a late-breaking presentation at the
American College of RheumatologyAnnual Meeting (ACR/ARP). In October 2019, Aptinyxannounced that data from its Phase 2 neuroimaging study of NYX-2925 in patients with fibromyalgia were selected to be presented in a late-breaking poster presentation at the ACR Annual Meeting. The results of the study show that NYX-2925 had statistically significant effects on neuroimaging biomarkers associated with central pain processing and that it significantly improved patient-reported symptoms of fibromyalgia. The ePoster was presented today, November 12, 2019in Atlanta, Georgia.
- Presented preclinical data on all three clinical-stage product candidates at the 49th Annual Meeting of the
Society for Neuroscience. In October 2019, Aptinyxannounced six presentations at the 49th Annual Meeting of the Society for Neuroscience. The presentations exhibited preclinical data supporting the development of each of the company’s three novel NMDA receptor modulators, NYX-2925, NYX-783, and NYX-458, in chronic pain, PTSD, and cognitive impairment, respectively.
- Three preclinical publications highlighted NMDA receptor activation facilitated by NYX-2925. In
September 2019, Aptinyxannounced the publication of three papers in peer-reviewed scientific journals. The publications describe the novel mechanism of action of NYX-2925 and demonstrate that its activation of NMDA receptors leads to enhanced synaptic plasticity, or neuronal communication.
- Former principal deputy commissioner of the
FDA, Rachel Sherman, M.D., joined the company’s Board of Directors. In September 2019, Aptinyxannounced that Dr. Sherman joined the company’s Board of Directors. She served at the FDAfor nearly 30 years, holding roles of increasing responsibility and influence. Dr. Sherman led numerous key initiatives credited with enhancing product development and facilitating patient access to innovative medicines, including expedited drug development and breakthrough therapy designation programs and the Opioid Policy Steering Committee.
- Initiation of Phase 2 study of NYX-458 in patients with mild cognitive impairment in Parkinson’s disease in 4Q 2019.
- Completion of, and reporting data from, Phase 2 first-in-patient study of NYX-783 in PTSD in 2H 2020.
- Completion of, and reporting top-line data from, Phase 2 study of NYX-2925 in painful DPN in late 2020 or early 2021.
- Completion of, and reporting top-line data from, Phase 2 study of NYX-2925 in fibromyalgia in 1H 2021.
Third Quarter 2019 Financial Results
Cash Position: Cash and cash equivalents were
Collaboration and Grant Revenue: Revenue was
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Net Loss: Net loss was
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the company’s business plans and objectives, including future plans or expectations for the company’s product candidates, therapeutic effects of the company’s product candidates, expectations regarding the design, implementation, timing, and success of its current and planned clinical studies, the timing for the company’s receipt of data from its clinical studies, expectations regarding its preclinical development activities, and expectations regarding its uses and sufficiency of capital. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the company’s product candidate development activities and planned clinical studies; the company’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in
|CONDENSED BALANCE SHEETS|
|Assets||September 30, 2019||December 31, 2018|
|Cash and cash equivalents||$||114,214||$||150,637|
|Prepaid expenses and other current assets||3,980||1,784|
|Total current assets||118,834||153,251|
|Property and equipment, net and other long-term assets||1,496||2,363|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||5,344||3,996|
|Total current liabilities||7,094||5,885|
|Other long-term liabilities||309||418|
|Total liabilities and stockholders’ equity||$||120,330||$||155,614|
|CONDENSED STATEMENTS OF OPERATIONS|
|(in thousands, except per share data)|
|Three Months Ended
|Nine Months Ended
|Research and development||11,761||11,950||33,732||37,860|
|General and administrative||4,523||3,782||14,419||7,853|
|Total operating expenses||16,284||15,732||48,151||45,713|
|Loss from operations||(15,348||)||(14,789||)||(45,400||)||(40,178||)|
|Net loss and comprehensive loss||$||(14,790||)||$||(14,181||)||$||(43,632||)||$||(39,188||)|
|Net loss per share - basic and diluted||$||(0.44||)||$||(0.43||)||$||(1.30||)||$||(2.48||)|
|Weighted average shares outstanding - basic and diluted||33,646||33,191||33,510||15,789|
Source: Aptinyx Inc.