Respirerx Pharmaceuticals Inc (OTCMKTS:RSPI) has received a copy of the Final Progress Report (the “Project Report”) with respect to the project titled “Cannabimimetic treatment of obstructive sleep apnea: A proof of concept trial” (the “Project”), grant number 5UM1HL112856. The Company received this Project Report from the National Heart, Lung and Blood Institute of the National Institutes of Health in response to a Freedom of Information Act (“FOIA”) request. A copy of the Project Report is attached as Exhibit 99.1 to this Current Report on Form 8-K.
As part of this Project, the University of Illinois and three other centers conducted a six week, placebo-controlled Phase 2B clinical trial investigating the effects of dronabinol in patients with obstructive sleep apnea (the “Clinical Trial”). The Company has licensed from the University of Illinois certain patent rights pertaining to the use of cannabinoids, including dronabinol, for the treatment of sleep-related breathing disorders such as obstructive sleep apnea. The Company did not manage or fund this Clinical Trial; this Clinical Trial was fully funded by the National Heart, Lung and Blood Institute of the National Institutes of Health and is being managed by University of Illinois researchers.
The Project Report describes preliminary data from three groups of patients who received either of two doses of dronabinol (2.5 or 10 mg) or placebo. The identities of the groups described in the Project Report remain blinded, but the Project Report indicates that significant group differences were observed in three of four primary outcome measures, including the Apnea-Hypopnea Index (AHI) and Epworth Sleepiness Scale (ESS). Unblinding of the group identities is expected to occur when the investigators have completed all planned primary and secondary analyses. The investigators have indicated that they “anticipate submitting an abstract detailing at least the top-line findings in December 2016, for presentation at the Sleep 2017 international conference of the Associated Professional Sleep Societies.” The investigators also stated they anticipate that they “will submit a peer-review manuscript detailing these findings in the Winter of 2017.”
The Company is not involved in the management of the Clinical Trial and takes no position on the information contained in the Project Report. The Company is providing the Project Report, which is publicly available, to update investors and shareholders with respect to the information available on the Clinical Trial, which the Company has discussed in its periodic filings with the Securities and Exchange Commission, including its most recently filed Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2016, as amended.
