Ovid Therapeutics COVID-19 Response

Ovid’s clinical studies are continuing. We are closely monitoring COVID-19 and the evolving impact on families in our clinical studies. Every location where our clinical studies are being conducted faces different challenges and disruptions, so it is crucial that families and site study teams remain in close contact. Ovid is in regular contact with each site to provide guidance.

If you are unable to contact your clinical study site, or are in need of additional information, please contact Ovid at clinicaltrials@ovidrx.com.

Currently, Ovid has three ongoing clinical studies in Angelman syndrome: The Phase 3 NEPTUNE Study, the Open-Label ELARA study and the Digital Study Capture to Understand Angelman Syndrome on OV101 (DISCUS). These clinical studies are proceeding. The safety of every member of the Angelman community is the core focus for Ovid during this global crisis, and we plan to proceed with empathy, integrity and responsibility. Ovid is working diligently with study teams at each site to address unforeseen challenges, and to remove obstacles for families participating in our studies.

For families currently enrolled in the NEPTUNE, ELARA and DISCUS studies:

• Families should follow study protocols and contact their clinical study site directly for guidance on upcoming visits, study procedures and any other concerns.
• If you are unable to contact your clinical study site or need additional information, please contact Ovid at: clinicaltrials@ovidrx.com and you will receive a response from a member of the Ovid team.

For additional information about the NEPTUNE study, please visit the study page on clinicaltrials.gov:

• The NEPTUNE study page on clinicaltrials.gov>>https://clinicaltrials.gov/ct2/show/NCT04106

For additional information about the ELARA study, please visit the study page on clinicaltrials.gov:

• The ELARA study page on clinicaltrials.gov >> https://clinicaltrials.gov/ct2/show/NCT03882918

Currently, Ovid has three ongoing rare epilepsy clinical studies: the ARCADE study in Dup15q Syndrome and CDKL5 Deficiency Disorder, the ELEKTRA study in Dravet Syndrome and Lennox Gastaut Syndrome, and the ENDYMION study, an open label extension for individuals who have successfully completed ARCADE and ELEKTRA. Both the ARCADE and ELEKTRA studies have recently been completed. The ENDYMION study is active and proceeding, and is currently enrolling individuals who have successfully completed ARCADE and ELEKTRA.

For individuals currently enrolled in the ENDYMION study:

• Families should follow study protocols and contact their clinical study site directly for guidance on upcoming visits, study procedures and any other concerns.
• If you are unable to contact your clinical study site or need additional information, please contact Ovid at: clinicaltrials@ovidrx.com and you will receive a response from a member of the Ovid team.

For individuals interested in participating in the ENDYMION open-label extension study who have successfully completed the ARCARDE or ELEKTRA studies:

• For those who are currently in screening, please contact your clinical study site directly for guidance on next steps or with any other concerns.
• For those interested in participating, please contact your ARCADE or ELEKTRA clinical study site directly for directions on next steps.

For additional information about the ARCADE, ELEKTRA and ENDYMION studies, please visit clinicaltrials.gov:

• The ARCADE study page on clinicaltrials.gov >> https://clinicaltrials.gov/ct2/show/NCT03694275
• The ELEKTRA study page on clinicaltrials.gov >> https://clinicaltrials.gov/ct2/show/NCT03650452
• The ENDYMION study page on clinicaltrials.gov >> https://clinicaltrials.gov/ct2/show/NCT03635073

The Phase 2 ROCKET study on OV101 in Fragile X has been completed and positive topline results have been released. OV101 met the study’s primary objective of safety and tolerability and produced statistically significant reductions in behavioral and functional symptoms in individuals with Fragile X syndrome. See press release >>

Families should contact their clinical study site directly for guidance on upcoming visits, study procedures and any other concerns. If you are unable to contact your clinical study site or are in need of additional information, please contact Ovid at clinicaltrials@ovidrx.com, and you will receive a response from a member of the Ovid team.

We are closely monitoring COVID-19 and the evolving impact on families in our clinical studies. Every location where our clinical studies are being conducted faces different challenges and disruptions, so it is crucial that families and site study teams remain in close contact.

Safety is our core focus during this global crisis, and we plan to proceed with empathy, integrity and responsibility. Ovid clinical teams are working diligently with study teams at each site to address unforeseen challenges, and to remove obstacles for families participating in our studies.

We will continue to provide updates on our clinical studies as the situation evolves.

We understand that the COVID-19 pandemic may cause challenges and disruptions in a family’s ability to travel while participating in a clinical study. Together with each study site, we are working on solutions. Families currently enrolled in an Ovid study should contact their clinical study site directly for specific guidance and to address any concerns.

If you are unable to contact your clinical study site or are in need of additional information, please contact Ovid at clinicaltrials@ovidrx.com, and you will receive a response from a member of the Ovid team.

Ovid is deeply appreciative of the hard work and dedication of our physicians and clinical research staff who are committed to supporting Ovid’s ongoing research.

For healthcare providers who are currently involved in Ovid’s clinical research studies:

We recognize that every clinical study site is facing different challenges and disruptions due to COVID-19. Given this, Ovid wants you to know we are here to support you during these difficult times. If you have questions about the clinical study you are currently involved in, please contact your Ovid representative directly.

For healthcare professionals not currently involved in Ovid’s clinical research studies:

Ovid’s clinical studies are continuing. A full listing of Ovid’s pipeline can be found at www.ovidrx.com/pipeline. We also have our studies listed at www.clinicaltrials.gov with specific links provided below.

Angelman syndrome:

• NEPTUNE Study information 
  The NEPTUNE study page on clinicaltrials.gov >> https://clinicaltrials.gov/ct2/show/NCT04106557
• ELARA Study information
  The ELARA study page on clinicaltrials.gov >> https://clinicaltrials.gov/ct2/show/NCT03882918

Fragile X syndrome:

• The Phase 2 ROCKET study of OV101 has been completed and positive topline results have been released. OV101 met the study’s primary objective of safety and tolerability and produced statistically significant reductions in behavioral and functional symptoms in individuals with Fragile X syndrome. See press release >>

Rare epilepsies:

• ARCADE Study information
  The ARCADE study page on clinicaltrials.gov >>
  https://clinicaltrials.gov/ct2/show/NCT03694275
• ELEKTRA Study information 
  The ELEKTRA study page on clinicaltrials.gov >>
  https://clinicaltrials.gov/ct2/show/NCT03650452
• ENDYMION Study information 
  The ENDYMION study page on clinicaltrials.gov >>
  https://clinicaltrials.gov/ct2/show/NCT03635073

Ovid has implemented processes that allow us to continue to supply our experimental medicines and support our communities. We are working closely with health authorities; federal, state and local governments; and distribution partners to ensure that we are meeting the needs of patients.

We do not anticipate any supply issues with any of our experimental medicines related to the global COVID-19 pandemic. However, given the uncertainty of the current environment, we are closely monitoring the situation as it evolves.

For patients with further questions, please contact Ovid at clinicaltrials@ovidrx.com.

For healthcare providers with further questions, please contact your Ovid representative directly.

We do not anticipate any issues with the supply of our experimental medicines related to the global COVID-19 pandemic. However, given the uncertainty of the current environment, we are closely monitoring the situation as it evolves.

Families should follow study protocols and contact their clinical study site directly for guidance on upcoming visits, study procedures and any other concerns.

If you are unable to contact your clinical study site, or are in need of additional information, please contact Ovid at clinicaltrials@ovidrx.com, and you will receive a response from a member of the Ovid team.

Ovid takes the health and safety of our employees, their families and our local communities very seriously, and we are closely monitoring COVID-19 and its evolving impact.

We have a COVID-19 Task Force dedicated to preparing for and protecting against the transmission of COVID-19 at our office locations and in the local community, while ensuring the critical work required to bring our medicines to those who need them continues.

The following mitigation measures have been implemented:

• A work from home mandate across all of our locations until further notice
• Restricting all travel
• Cancelling/postponing all in-person Ovid meetings and events
• Cancelling/postponing Ovid employees from participating in any external meetings and events
• Conducting virtual meetings to ensure day-to-day business continuity
• Working closely with appropriate health authorities and fully complying with all applicable regulations and protocols

We want our community partners to know that the COVID-19 situation will not impact our current grant programs with community organizations. We will continue to communicate regularly with our partners in order to continue to support initiatives, institutions, or other community needs.

We look forward to continuing our work—together—to positively impact the lives of patients, families, and caregivers.

Our commitment to our families and communities remains unwavering. Please know that Ovid is with you during these challenging times. Below is a list of resource websites that you may find to be helpful with respect to the COVID-19 pandemic.

General COVID-19 information

www.cdc.gov/coronavirus/2019-ncov/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2Findex.html

www.who.int/emergencies/diseases/novel-coronavirus-2019

COVID-19 resources for the rare disease community

https://globalgenes.org/coronavirus-covid-19-resources

COVID-19 and children including those with special health care needs

www.cdc.gov/coronavirus/2019-ncov/prepare/children-faq.html

Manage stress and anxiety

www.cdc.gov/coronavirus/2019-ncov/prepare/managing-stress-anxiety.html

Links to state health departments for current local information (United States’ residents)

www.cdc.gov/publichealthgateway/healthdirectories/healthdepartments.html