Phase 3 Trial Aims to Establish Non-Motor Improvement in Parkinson’s

Phase 3 Trial Aims to Establish Non-Motor Improvement in Parkinson’s

PhotoPharmics and University of Rochester to Collaborate on Stay-At-Home Trial

July 14, 2020, Salt Lake City, UT— PhotoPharmics, a pioneer in specialized phototherapy for neurodegenerative diseases, today announced a collaboration with the Center for Health + Technology (CHeT) at the University of Rochester Medical Center to conduct an at home, telemedicine, phase 3 trial to establish safety and efficacy for the company’s non-invasive specialized phototherapy device for Parkinson’s disease.

This follows the FDA’s Breakthrough Device Designation for the trial device in April 2020 (see announcement).

“Our first trial showed improvement in quality of life on top of best managed care,” said Dan Adams, Science Officer at PhotoPharmics. Although the MDS-UPDRS part 1 was not designated as a secondary outcome, it was significant (-2.5 points, p=0.006), with 11/13 of the subitems moving in favor of the treatment. This is something we have never seen before, and may signal for the first time, broad, general improvement in non-motor symptoms. We think this is why the FDA granted this therapy a Breakthrough Designation. According to the International Movement Disorder Society, ‘…treatment options overall remain limited… and new treatments for non-motor symptoms in PD remains a top priority.’”

“A stay-at-home trial featuring a non-invasive device is perfect for our time,” said Dr. Ray Dorsey, lead investigator for the trial and director of CHeT. “Our team will assess a patient’s progress via video conference in the most natural and accurate setting—the convenience of their own home. Anyone with Parkinson’s from across the country can apply, even those in remote locations as long as they have an internet connection.”

Called the “Celeste Light for PD Trial,” this six-month phase 3 trial will feature Celeste®, a specialized light therapy device. Participants will use Celeste daily while enjoying their usual activities in the evening (such as watching TV, eating, reading, or using a computer). Celeste is convenient and non-invasive. It should be used along with current medical care so participants will not need to alter their existing medical regime. All clinical interactions between participants and researchers will be completed via teleconference so patients will not be required to travel.  This opens the trial to patients across the country and participation should not increase the risk for COVID-19 infection. Additional trial details can be reviewed at Clinicaltrials.gov (#NCT04453033).

Dopaminergic therapies have long been the mainstay for treating motor features in Parkinson’s disease. “More needs to be done to address the devastating non-motor symptoms of PD,” said Adams. “In addition to motor function, the Celeste trial aims to address the wide-spread, critical unmet needs associated with non-motor function—such as sleep, fatigue, depression, anxiety, and cognition. No current therapy addresses general non-motor function, which can be more debilitating than motor function, and eventually may be the cause for institutionalization.”

The trial will begin in the fall and will be limited to 200 participants. Learn more at photopharmics.com.

About CHeT

The Center for Health + Technology (CHeT) is a clinical research organization within the University of Rochester. Their team designs and conducts multi-center clinical trials with collaborators from across the globe to accelerate clinical research and advance the development of therapeutics, benefiting individuals in our community and beyond. Since its inception over three decades ago, CHeT has reshaped the conduct of clinical trials, from incorporating novel technologies into clinical trial design to modeling disease progression. Learn more at https://www.urmc.rochester.edu/health-technology.aspx.

About PhotoPharmics

PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative diseases. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms in seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective non-invasive treatments. Investor inquiries are welcomed. Learn more at www.photopharmics.com.

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FDA Grants Breakthrough Designation for Non-Invasive Phototherapy Device in Parkinson’s Disease

FDA Grants Breakthrough Designation for Non-Invasive Phototherapy Device in Parkinson’s Disease

PhotoPharmics achieves priority designation for innovative PD therapy

April 29, 2020, Salt Lake City, UT— PhotoPharmics, a pioneer in specialized phototherapy, today announced that it has received FDA Breakthrough device designation for the company’s non-invasive Specialized Phototherapy Device.  This prescription device is intended as an adjunct therapy for the treatment of Parkinson’s disease. It is intended to be used concurrently with standard dopaminergic therapy and is designed primarily for home use. 

“Very few device companies receive Breakthrough designation. Our device is the first specialized phototherapy device to achieve this status,” said Kent Savage, CEO of PhotoPharmics. “Our focus is to help people with Parkinson’s improve function and return to what they enjoy doing most. We think this recognition by FDA validates our work.”

The Breakthrough Devices Program is intended to deliver more timely access to medical devices that provide for more effective treatment of life-threatening or irreversibly debilitating diseases. In order to receive Breakthrough designation, companies must demonstrate credible evidence that their technology addresses unmet need and offers potential improvements over current standard treatments.

According to the Parkinson’s Foundation, over one million Americans and ten million people worldwide suffer with Parkinson’s disease, a number which is expected to double within the next 20 years. Nearly 60,000 Americans are newly diagnosed each year.

PhotoPharmics is currently raising a B round to finance their pivotal, phase 3 study of this new technology and intends to begin recruiting in August 2020. Inquiries about this upcoming trial are welcomed at www.photopharmics.com.

About PhotoPharmics

PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms in seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective non-invasive treatments. Investor inquiries are welcomed. Learn more at www.photopharmics.com.

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Largest Phototherapy Trial for Parkinson’s Disease

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Largest Phototherapy Trial for Parkinson’s Disease

PhotoPharmics Finalizing Pivotal Phase 3-Equivalent Trial for Improving Overall Function

February 10, 2020, Salt Lake City, UT— PhotoPharmics announced today plans to conduct a pivotal trial to assess the efficacy of Celeste®, the company’s specialized phototherapy device to improve overall function in Parkinson’s disease (PD). The Celeste device builds on the company’s innovative Spectramax™ technology that has been used in previous human research. The company anticipates enrolling approximately 200 people in what will likely be the largest trial of its kind, the final details of which are forthcoming.

“We’re delighted to stage a trial of this size and importance,” said Kent Savage, president and CEO of PhotoPharmics. “This follows the success of our phase 2 trial in Parkinson’s which suggested meaningful improvement in function and quality of life in PD, in the setting of best medical management.” The magnitude of changes found on the MDS-UPDRS Parts 1+2 (experiences of daily living) (-4.0 points, p=0.037) and the PDQ 39 (-5.7 points, p=0.038) were both clinically meaningful.

Celeste phototherapy is based on the observation that the circadian system is dysregulated in PD, which can affect everything from tremor to sleep, cognition, mood, and fatigue.[1] This type of specialized phototherapy is intended to target the photoreceptors in the eye that are responsible for circadian signaling to the brain.

“A pivotal trial for medical devices is similar to a phase 3 trial drug trial,” said Dan Adams, chief science officer. “As patients reported in our prior trial, this may be the only treatment that improves functional abilities in PD when administered on top of current medication. We recently presented our new trial design to the FDA with a favorable review, and we are planning on recruiting participants for our trial in the second half of 2020.”

People with Parkinson’s disease and their caregivers may register to receive information about the upcoming trial at https://photopharmics.com/patient-experience/.

Focus of the Trial

Current treatments for PD primarily treat motor symptoms, and very few options exist for the debilitating non-motor problems that are also part of the disease. As Parkinson’s progresses, these non-motor issues become even more pronounced and are often the determining factors for quality of life and institutionalization.[2] In fact, the Movement Disorders Society has identified these debilitating non-motor problems as a major unmet therapeutic need.[3]

About PhotoPharmics

PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective treatments. Learn more at www.photopharmics.com.

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[1] Fifel K, Videnovic A. Light therapy in Parkinson’s disease: towards mechanism-based protocols. Trends in neurosciences. 2018 May 1;41(5):252-4.

[2] Schapira, A., Chaudhuri, K. & Jenner, P. Non-motor features of Parkinson disease. Nat Rev Neurosci 18, 435–450 (2017).

[3] Seppi K, Ray Chaudhuri K, Coelho M, Fox SH, Katzenschlager R, Perez Lloret S, Weintraub D, Sampaio C, collaborators of the Parkinson’s Disease Update on Non‐Motor Symptoms Study Group on behalf of the Movement Disorders Society Evidence‐Based Medicine Committee, Chahine L, Hametner EM. Update on treatments for nonmotor symptoms of Parkinson’s disease—an evidence‐based medicine review. Movement Disorders. 2019 Feb;34(2):180-98.

Pivotal Parkinson’s Disease Clinical Trial Results Released at the International Movement Disorders Society Congress

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Pivotal Parkinson’s Disease Clinical Trial Results Released at the International Movement Disorders Society Congress

PhotoPharmics Study Reveals Phototherapy Breakthrough

October 5, 2018, Hong Kong, China—PhotoPharmics today released the results of its multinational, double blind, randomized controlled trial in Parkinson’s disease at the annual International Movement Disorders Society meeting in Hong Kong. The study is entitled “Double-blind controlled trial of Spectramax™ light therapy for the treatment of Parkinson’s disease patients on stable dopaminergic therapy.”

“Our study is the first long-term phototherapy trial with the objective of demonstrating the safety and efficacy of our proprietary Spectramax technology in improving the overall disease,” said Kent Savage, CEO of PhotoPharmics. “This poster presentation is a significant milestone for patients with Parkinson’s disease and showcases what may be the only adjunctive therapy to improve Parkinson’s disease symptoms on top of the dopaminergic medications that patients are likely already taking.”

“At the Hong Kong conference, we will also be consulting with several leading movement disorders specialists to discuss next steps for introducing this new technology,” said Savage. “We will also be exploring additional human clinical trials to further investigate specific bandwidth phototherapy in neurodegenerative diseases.”

The 6-month study involved 92 highly heterogenous subjects who were treated for one hour in the evening. Subjects were assessed during the ON state. A clinically meaningful improvement was found in favor of the Active group over controls on disease severity as measured by the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) (-8.0 LSM difference, p=0.07). Significance was found for the PDQ-39 (-5.7 LSM difference, p<0.05) and non-motor (MDS-UPDRS Part I = -2.5 LSM difference, p<0.01), with a trend on the ESS (-1.5 LSM difference, p=0.05).

“The circadian system is dysregulated in Parkinson’s disease, which shows a blunted circadian profile,” said Dan Adams, Science Officer for PhotoPharmics. “The circadian system exerts a major influence on our daily sleep and activity,” said Adams, “So improving circadian regulation should impact both motor and non-motor problems in Parkinson’s. We know that therapeutic light is the most powerful tool for circadian regulation, and based on our experience in treating circadian related disorders with specific bandwidth phototherapy, we believe we can make a major difference in treating PD.”

The significant non-motor improvement seen by the patients is important, as limited options are available for non-motor problems in Parkinson’s disease. The study was conducted at three CNS or neurology clinics at the Vrije Universiteit Medical Center in Amsterdam, Massachusetts General Hospital in Boston, and Aspen Clinical Research in Salt Lake City.

About the MDS/International Congress

The International Parkinson and Movement Disorder Society (MDS) is a professional society of over 7,000 clinicians, scientists and other healthcare professionals dedicated to improving the care of patients with movement disorders through education and research. The MDS gathers thousands of the field’s clinicians, researchers, trainees and industry supporters on an annual basis at its International Congress of Parkinson’s Disease and Movement Disorders.

This year’s International Congress is taking place in Hong Kong, October 5-9, 2018. The meeting is being held at the Hong Kong Convention and Exhibition Centre. Visit www.mdscongress.org for more information.

About PhotoPharmics

PhotoPharmics is a privately-held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective treatments. Learn more at www.photopharmics.com.

PhotoPharmics Submits FDA Application for Parkinson’s Disease Therapy

PhotoPharmics Submits FDA Application for Parkinson’s Disease Therapy

510K De Novo Pathway Key to Market Authorization for Company’s Innovative Medical Device

July 16, 2018, Salt Lake City, UT— PhotoPharmics announced today that its De Novo request to the FDA has been accepted for review of the company’s Spectramax™ specialized phototherapy medical device for treating Parkinson’s disease.

“This is an exciting milestone in our company’s history,” said Dan Adams, Science Officer for PhotoPharmics. “We met with the FDA earlier this year to discuss the results of our pivotal clinical trial which paved the way for our submission. This is the culmination of several years of planning, regulatory and quality system execution, clinical trial design and management, data collection and statistical analysis.”

“It is exciting to be at this stage as a company,” said Kent Savage, CEO of PhotoPharmics. “We have accomplished a great deal with the support of some of the most capable movement disorder, regulatory, quality, legal, and statistical teams in the country. Our positive clinical data combined with the non-risk nature of our device means we’re optimistic about market authorization in the coming months.”

The De Novo pathway is available to organizations that can show low to moderate risk for their medical device, and where no  predicate device has been cleared by the FDA. If approved, Spectramax specific bandwidth phototherapy could be the first treatment for Parkinson’s disease which offers symptomatic relief without significant side effects.

About PhotoPharmics

PhotoPharmics is a privately-held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective treatments. Learn more at www.photopharmics.com.

PhotoPharmics Completes Pivotal Phototherapy Clinical Trial for Parkinson’s Disease

PhotoPharmics Completes Pivotal Phototherapy Clinical Trial for Parkinson’s Disease

Double-Blind Trial Demonstrates Safety and Efficacy of Spectramax™ Medical Device

February 1, 2018, Salt Lake City, UT—PhotoPharmics completed a multinational double-blind, randomized clinical trial of its pivotal Spectramax™ medical device to demonstrate safety and efficacy of the company’s specific bandwidth phototherapy for overall improvement in Parkinson’s disease.

“Completing this clinical investigation is a major milestone for us—and for Parkinson’s disease patients,” said Kent Savage, CEO of PhotoPharmics. “To our knowledge, this is the first study of its kind to suggest a large, clinically meaningful benefit on top of other Parkinson’s disease therapies.”

“We were able to study the long-term effects of specific bandwidth light therapy for people with Parkinson’s disease,” said Savage. “Our findings show promise for patients hoping to improve their condition, especially with non-motor symptoms where options are so limited. Because of this trial, we now better understand the effects of wavelengths, intensities, and time of day of light administration—to be included in our patented technology we call Spectramax.”

The company’s Spectramax clinical trial device demonstrated that specific light wavelengths are convenient and safe. Participants in the clinical trial primarily used the device by sitting at a table or desk with the device in front of them illuminating their faces. They were able to watch TV, read, eat, and socialize while receiving their light treatment.

“Improving the quality of life and minimizing side effects are important objectives for people with Parkinson’s disease, and we are very close to finding solutions!” said Dan Adams, Science Officer at PhotoPharmics. “Unlike many Parkinson’s disease investigations, which measure potential benefits for patients after their standard dopaminergic therapy has worn off, we measured patients in their best or ‘ON’ state to see if we could deliver any improvement. We saw a strong signal for motor performance, but we were even more surprised with the significant non-motor improvement and the large improvements on quality of life.”

This multi-center, multi-national, randomized, double-masked, controlled, parallel‑group, trial involved 92 patients and established the safety and efficacy of Spectramax phototherapy for motor and non-motor symptoms in Parkinson’s disease. The trial was conducted at the Massachusetts General Hospital, Boston; Vrije Universiteit Medical Center, Amsterdam; Aspen Clinical Research, Salt Lake City.

PhotoPharmics will present the results from this study at the 2018 Movement Disorders Society’s annual meeting (Hong-Kong, October 5-9, 2018).

Additional details regarding the trial can be found on the Michael J Fox Trial Finder (https://foxtrialfinder.michaeljfox.org/trial/3870/) and clinicaltrials.gov (#NCT02175472).

About PhotoPharmics

PhotoPharmics is a privately-held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective treatments. Learn more at www.photopharmics.com.