Four Phase 2 studies expected to be ongoing by year end; multiple data read-outs anticipated in 2019 and 2020
Management to host conference call today at
“So far, 2019 has been marked by the achievement of key milestones and important clinical study results that form the basis for several of our upcoming Phase 2 studies,” said
First Quarter 2019 and Recent Clinical Program Highlights
- Reported positive results from Phase 1 study of NYX-458, in development for Parkinson’s disease cognitive impairment: In
April 2019, Aptinyxreported positive results from a Phase 1 clinical study evaluating the safety, tolerability, pharmacokinetics, and CNS penetration of NYX-458 in healthy volunteers. In the study, NYX-458 was safe and well tolerated with no serious adverse events reported. NYX-458 exhibited a dose-proportional and predictable pharmacokinetic profile across a very wide dose range. As evaluated through measurement of concentration in cerebral spinal fluid, NYX-458 readily crosses the blood brain barrier and achieves ample CNS exposure in line with that observed at preclinically efficacious doses. The company expects to initiate a Phase 2 study in the second half of 2019.
- Reported robust analgesic activity of NYX-2925 in advanced DPN patients: In
April 2019, Aptinyxpresented detailed results from a 300-subject Phase 2 study in patients with painful DPN at the annual meeting of the American Pain Society. While statistically significant separation from placebo was not achieved for the primary endpoint in the total study population, post hoc analysis demonstrated increasing therapeutic benefit of NYX-2925 in patients suffering from DPN for a longer period of time. In particular, the company highlighted results showing that patients in the study who had been diagnosed with DPN for four years or longer (N=127) experienced a clinically meaningful and significant alleviation of their pain with NYX-2925 (p=0.004 vs. placebo). In advanced DPN patients, the 50 mg dose group showed the greatest separation from placebo on the primary efficacy endpoint, and these effects were even more pronounced for patients in this sub-group not taking a concomitant analgesic. These results, which were consistent across the various endpoints in the study, inform the future development of NYX-2925 in chronic pain and the company expects to initiate a Phase 2 study in patients with advanced DPN in the second half of 2019.
- Presented data showing NYX-458 reversed cognitive deficits in a non-human primate model of Parkinson’s disease: In
March 2019, Aptinyxpresented findings from two non-human primate studies at the International Conferenceon Alzheimer’s & Parkinson’s Diseases (AD/PD™) in Lisbon, Portugal. The results from the first study demonstrated that, in a highly translatable model of Parkinson’s disease cognitive impairment, NYX-458 reversed cognitive deficits in a rapid, robust, and enduring manner. This study employed chronic low doses of MPTP, a neurotoxin, to deplete dopaminergic neurons and induce cognitive deficits similar to those experienced by patients with Parkinson’s disease. In the second study, using higher doses of MPTP to induce parkinsonian-like motor symptoms, NYX-458 did not worsen motor symptoms or interfere with the anti-parkinsonian effects of levodopa therapy, the standard of care to treat the motor symptoms of Parkinson’s disease.
- Initiated Phase 2 study of NYX-783 for treatment of PTSD: In
February 2019, Aptinyxinitiated a Phase 2 clinical study of NYX-783 to characterize its safety, pharmacokinetics, and effects on symptoms in patients with PTSD. Approximately 144 patients will be enrolled and randomly assigned to receive either placebo or NYX-783 over the course of the eight-week study. Multiple efficacy endpoints will be evaluated in the study to assess the impact of NYX-783 across the spectrum of PTSD symptoms. The company expects to report data from this study in the first half of 2020.
Recent Operational Highlight:
- Announced election of
Henry Gosebruchto the Board of Directors: In early May, Aptinyxannounced the election of industry veteran Henry O. Gosebruchto its board of directors. Mr. Gosebruch is currently executive vice president and chief strategy officer at AbbVie and was formerly co-head of J.P. Morgan’s North American M&A Group. His industry expertise and insights will be valuable as the company expands and moves forward with its pipeline of innovative NMDA receptor-modulating therapy candidates.
Expected Near-Term Milestones
- Completion of, and reporting data from, NYX-2925 exploratory Phase 2 study in fibromyalgia in 1H 2019.
- Completion of, and reporting top-line data from, Phase 2 first-in-patient study of NYX-783 in PTSD in 1H 2020.
First 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: For the first quarter of 2019, 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||March 31, 2019||December 31, 2018|
|Cash and cash equivalents||$||136,580||$||150,637|
|Prepaid expenses and other current assets||1,518||1,784|
|Total current assets||138,765||153,251|
|Property and equipment and other long-term assets||2,228||2,363|
|Liabilities and stockholders’ equity (deficit)|
|Accrued expenses and other current liabilities||4,586||3,996|
|Total current liabilities||5,923||5,885|
|Other long-term liabilities||384||418|
|Stockholders’ equity (deficit)||134,686||149,311|
|Total liabilities and stockholders’ equity (deficit)||$||140,993||$||155,614|
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
|Three Months Ended
|Research and development||12,490||12,224|
|General and administrative||5,725||2,049|
|Total operating expenses||18,215||14,273|
|Loss from operations||(17,325||)||(11,809||)|
|Net loss and comprehensive loss||$||(16,711||)||$||(11,672||)|
|Net loss per share - basic and diluted||$||(0.50||)||$||(2.17||)|
|Weighted average shares outstanding - basic and diluted||33,390||5,378|
Source: Aptinyx Inc.