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Relmada Therapeutics Top-Line Results of REL-1017
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Relmada Therapeutics teilt Einbruch des Phase-3-Studienversagens >RLMD
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Conference Call and Webcast Information
Relmada will host a conference call and webcast presentation today, July 27, 2021 at 8:30 AM Eastern Time to discuss the study results, which can be accessed with the information below:
Tuesday, July 27 at 8:30 AM ET
Domestic:
877-407-0792
International:
201-689-8263
Conference ID:
13721997
Webcast:
public.viavid.com/index.php?id=145999
The subsequent archived recording will be available on the Investors section of the Relmada website at www.relmada.com.
Background
REL-1017 (which is also known as esmethadone, dextromethadone, or d-methadone), is the opioid-inactive, dextro- or right-side isomer of racemic methadone. Prior preclinical and clinical findings have indicated that the dextro-isomer REL-1017 lacks the addiction liability and respiratory depressant effects of its parent molecule. In contrast, levomethadone, the left-side isomer, is an opioid agonist and is entirely responsible for the analgesic activity of the parent molecule.1
Human Abuse Potential (HAP) studies are conducted to evaluate the likelihood that a medicine affecting the central nervous system may be abused by patients or the general public. The study comparing REL-1017 to oxycodone is the first of two clinical trials to assess abuse potential per FDA guidance as part of the planned REL-1017 NDA for the treatment of MDD.
The scheduling of a drug depends on the analysis of several parameters (receptor studies, animal studies, human studies, history of abuse). These parameters are generally referred to as the "eight factor analysis". All tested parameters suggest a lack of any meaningful abuse potential for REL-1017 and are fully aligned with the 2019 DEA statement on methadone.1
About The Human Abuse Potential Study for REL-1017 vs. Oxycodone
The study was a single-dose, Phase 1, randomized, double-blind, double-dummy, active- and placebo-controlled, five-way crossover study to assess the abuse potential of REL-1017 relative to oxycodone and placebo in healthy experienced recreational drug users. Oxycodone, the active control, was administered at the dose of 40 mg, a standard dose in HAP studies. A total of 50 subjects were enrolled and 44 fulfilled criteria for the predefined statistical analysis.
Once available, the full data set and detailed results will be submitted to the FDA and for presentation at future scientific conferences and publication in peer-reviewed journals.
About REL-1017
REL-1017, a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development for the treatment of MDD. The ongoing RELIANCE Clinical Research Program is designed to evaluate the potential for REL-1017 as the first rapid-acting, oral, once-daily antidepressant treatment. In a Phase 2 trial, REL-1017 demonstrated robust, rapid and sustained antidepressant effects with statistically significant improvements compared to placebo. The Phase 2 study also confirmed the favorable pharmacokinetic, safety and tolerability profile of REL-1017 observed in previously completed Phase 1 studies.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Our experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada' s lead program, REL-1017, is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 has entered late-stage development as an adjunctive treatment for MDD in adults. Learn more at www.relmada.com.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to," "potential," "promising," and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Tim McCarthy
LifeSci Advisors
917-679-9282
tim@lifesciadvisors.com
Media Inquiries:
FischTank PR
Relmada@FischTankPR.com
Reference:
1. DEA: Diversion Control Division. December 2019. Accessed May 2020. www.deadiversion.usdoj.gov/drug_chem_info/...ne/methadone.pdf
Cision View original content to download multimedia:www.prnewswire.com/news-releases/...-potential-301341996.html
SOURCE Relmada Therapeutics, Inc.
Relmada will host a conference call and webcast presentation today, July 27, 2021 at 8:30 AM Eastern Time to discuss the study results, which can be accessed with the information below:
Tuesday, July 27 at 8:30 AM ET
Domestic:
877-407-0792
International:
201-689-8263
Conference ID:
13721997
Webcast:
public.viavid.com/index.php?id=145999
The subsequent archived recording will be available on the Investors section of the Relmada website at www.relmada.com.
Background
REL-1017 (which is also known as esmethadone, dextromethadone, or d-methadone), is the opioid-inactive, dextro- or right-side isomer of racemic methadone. Prior preclinical and clinical findings have indicated that the dextro-isomer REL-1017 lacks the addiction liability and respiratory depressant effects of its parent molecule. In contrast, levomethadone, the left-side isomer, is an opioid agonist and is entirely responsible for the analgesic activity of the parent molecule.1
Human Abuse Potential (HAP) studies are conducted to evaluate the likelihood that a medicine affecting the central nervous system may be abused by patients or the general public. The study comparing REL-1017 to oxycodone is the first of two clinical trials to assess abuse potential per FDA guidance as part of the planned REL-1017 NDA for the treatment of MDD.
The scheduling of a drug depends on the analysis of several parameters (receptor studies, animal studies, human studies, history of abuse). These parameters are generally referred to as the "eight factor analysis". All tested parameters suggest a lack of any meaningful abuse potential for REL-1017 and are fully aligned with the 2019 DEA statement on methadone.1
About The Human Abuse Potential Study for REL-1017 vs. Oxycodone
The study was a single-dose, Phase 1, randomized, double-blind, double-dummy, active- and placebo-controlled, five-way crossover study to assess the abuse potential of REL-1017 relative to oxycodone and placebo in healthy experienced recreational drug users. Oxycodone, the active control, was administered at the dose of 40 mg, a standard dose in HAP studies. A total of 50 subjects were enrolled and 44 fulfilled criteria for the predefined statistical analysis.
Once available, the full data set and detailed results will be submitted to the FDA and for presentation at future scientific conferences and publication in peer-reviewed journals.
About REL-1017
REL-1017, a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development for the treatment of MDD. The ongoing RELIANCE Clinical Research Program is designed to evaluate the potential for REL-1017 as the first rapid-acting, oral, once-daily antidepressant treatment. In a Phase 2 trial, REL-1017 demonstrated robust, rapid and sustained antidepressant effects with statistically significant improvements compared to placebo. The Phase 2 study also confirmed the favorable pharmacokinetic, safety and tolerability profile of REL-1017 observed in previously completed Phase 1 studies.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Our experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada' s lead program, REL-1017, is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 has entered late-stage development as an adjunctive treatment for MDD in adults. Learn more at www.relmada.com.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to," "potential," "promising," and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Tim McCarthy
LifeSci Advisors
917-679-9282
tim@lifesciadvisors.com
Media Inquiries:
FischTank PR
Relmada@FischTankPR.com
Reference:
1. DEA: Diversion Control Division. December 2019. Accessed May 2020. www.deadiversion.usdoj.gov/drug_chem_info/...ne/methadone.pdf
Cision View original content to download multimedia:www.prnewswire.com/news-releases/...-potential-301341996.html
SOURCE Relmada Therapeutics, Inc.
* an der Börse ist alles möglich, auch das unmögliche !
Phase3 Studie REL-1017 (MDD) floppt
endpts.com/...laming-paradoxical-placebo-effect-shares-wiped/
erneut negative Phase3 Studiendaten (dieses Mal RELIANCE I)
www.relmada.com/investors/news/...top-line-results-from-phase
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