Teva and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable in Adults with Schizophrenia

Teva and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable in Adults with Schizophrenia 

Euronext: MEDCL - Montpellier - France – May 8, 2024 - 12:30 PM (CEST)

• The study met its primary endpoint achieving clinically meaningful and statistically significant reductions across all TEV-‘749 dose groups versus placebo in the Positive and Negative Syndrome Scale (PANSS) total score, a widely used assessment tool for schizophrenia symptom severity   

• TEV-‘749 was well tolerated, with no incidence of post-injection delirium/sedation syndrome (PDSS) observed to date: additional safety data is being collected as part of the long-term follow-up SOLARIS study

• TEV-‘749 is being developed by Teva as a once-monthly subcutaneous long-acting injection of olanzapine with the use of SteadyTeq™ technology, a copolymer technology proprietary to Medincell

Parsippany, N.J., TEL AVIV & PARIS, May 08, 2024 – Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), today announced results from the efficacy portion of the Phase 3 Subcutaneous OLAnzapine extended-Release Injection Study (SOLARIS) trial evaluating TEV-‘749 in adult patients with schizophrenia compared to placebo. Results demonstrated that TEV-‘749 met its primary endpoint as measured by a change in the PANSS total score from baseline after 8 weeks compared to placebo. TEV-‘749 utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady release of olanzapine, the most prescribed 2nd generation antipsychotic for schizophrenia in the U.S1.

TEV-‘749 met its primary endpoint across all three dosing groups, with mean difference in change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8 of -9.71 points, -11.27 points, and -9.71 points  versus placebo for the high, medium, and low dose groups, respectively. These differences from placebo were clinically meaningful and statistically significant with adjusted P-values of 0.001 for each comparison. Key secondary endpoints of CGI-S (Clinical Global Impressions – schizophrenia) and PSP (Personal and Social Performance Scale) total score were also statistically significant after adjusting for multiplicity.  No cases of PDSS have been reported to date, after administration of approximately 80% of the target injection number.

An estimated 3.5 million people are currently diagnosed with schizophrenia in the U.S. It is a chronic, progressive, and severely debilitating mental disorder that affects how one thinks, feels and behaves. Currently, there is no long-acting olanzapine treatment option available for schizophrenia that does not risk post-injection delirium/sedation syndrome (PDSS). PDSS is characterized by the sudden and unexpected onset of delirium or sedation within the first several hours of receiving treatment and has been associated with the intramuscular injection of long-acting olanzapine.

“These encouraging results from the efficacy portion of our Phase 3 SOLARIS trial demonstrate the potential of TEV-‘749 to be an effective long-acting treatment option for schizophrenia and further show our dedication to advancing innovative science in mental health and beyond,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “Schizophrenia can be a devastating disease for both the people struggling with it as well their families. Schizophrenia is often a chronic life-long disease, but by using medication consistently, people can find the treatment help they deserve. This also has the potential to reduce the burden for not only themselves, but their caregivers and loved ones as well.”

The PANSS is composed of 3 subscales: Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. Each of the 30 items is accompanied by a specific definition as well as detailed anchoring criteria for all seven rating points. These seven points represent increasing levels of psychopathology, as follows: 1- absent 2- minimal 3- mild 4- moderate 5- moderate severe 6- severe 7- extreme; the PANSS overall total score ranges from 30 to 210, with a higher score indicating greater symptom severity. The primary efficacy endpoint was measured by change from baseline to week 8 against the PANSS total score.

“These data reinforce the potential of TEV-‘749 as a subcutaneous long-acting injectable by using a proven molecule with an established long-acting delivery system,” said Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, Hempstead, NY and SOLARIS study co-ordinating investigator. “Most patients with schizophrenia will experience one or more relapses throughout their treatment journeys, so I very much welcome the development of new and innovative long-acting treatment options that may better fit into their lives.”

"The positive news from the phase III SOLARIS trial continues to encourage ongoing innovation in treatment options for those living with schizophrenia. We are thrilled to be part of this journey with Teva through a strong partnership that allows us to leverage our pioneering long-acting technology for the benefit of patients,” said Christophe Douat, CEO of Medincell.

Additional efficacy and safety findings from the Phase 3 SOLARIS study are planned for presentation at a medical meeting later this year.

The long-term safety of TEV-‘749 and incidence of PDSS are also being evaluated in the SOLARIS open-label study (period 2) with safety data topline readout expected in the second half of 2024.

TEV-‘749 is an investigational once-monthly subcutaneous long-acting injection of the 2nd generation antipsychotic olanzapine and is not approved by any regulatory authority for any use and its safety and efficacy are not established.

1 NPA TRx - MAT Jan 2024; schizophrenia factors sourced from 2022 Analytics Link (IQVIA)

About MedinCell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY® (BEPO® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities.

UZEDY® and SteadyTeq™ are trademarks of Teva Pharmaceuticals

www.medincell.com