You are here: Home » Archives for Clinical Study

Apex Labs Granted Israel MoH Approval to Expand Phase 2b Macrodose Psilocybin PTSD Clinical Trial

  • Israel’s Ministry of Health (MoH) approval to add additional sites to APEX SUMMIT–90 160 patient phase 2b macrodose clinical trial:
    • Tel Aviv University (TAU)’s Institute for Psychedelic Research located at the Sagol Brain Institute (SGI) in Tel–Aviv Sourasky Medical Center.
    • Be'er Yaakov Mental Hospital (Merhavim) Center for Psychedelic Studies.
  • For more information or to register visit clinicaltrials.gov (Canada) and mytrials.gov (Israel).

VANCOUVER, British Columbia, June 12, 2025 (GLOBE NEWSWIRE) — Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with psilocybin is pleased to announce the approval by the Israeli MoH and IRBs to open two additional clinical trial sites for SUMMIT–90. The trial is a double–blind, placebo controlled phase 2b study evaluating multiple doses of APEX–90, a psilocybin macrodose utilizing APEX’s US patent pending capsule. APEX–90 is administered in–clinic with study–assisted psychotherapy for severe depression within diagnosed PTSD. Israel is facing a severe mental health crisis: 44% of adults report depression and 42% PTSD, far above the 8–13% depression and 6–10% PTSD rates seen in the US and Canada.

This MoH approval leverages the expertise of TAU’s renowned SGI and Merhavim Hospital, which both have a rich history of pioneering research in neurological sciences. Their cutting–edge facilities and teams profound understanding of PTSD dynamics are poised to add patient recruitment expertise.

“I am honoured to have been able to facilitate this new partnership; another example of building important bridges between Canada and Israel in innovative clinical research, which will result in advancing patient access to emerging treatments,” says Sharon J. Fraenkel, TAU Canada’s CEO for Ottawa, Quebec, and Atlantic Canada, on behalf of the organization.

“As someone deeply connected to Israel, witnessing the toll of PTSD among my loved ones, I'm driven to lead research that brings hope and healing,” says Alysa Langburt, APEX’s VP of Global Clinical Development. “This marks more than a clinical milestone, it represents a fundamental step towards transforming the mental health landscape in Canada and Israel, where the need has never been greater. Through our incredible partnerships, we aim to catalyze a shift in access, care and outcomes for those suffering with PTSD.”

“SUMMIT–90 offers a beacon of hope for the significant numbers suffering from PTSD in Canada and Israel,” says Tyler Powell, co–Founder and CEO of APEX. “It underscores our commitment to global mental health innovation and our belief in the opportunity for clinically proven psilocybin therapies to transform mental health care.”

About Apex Labs Ltd.
APEX is a patient–driven pharmaceutical company focused on revolutionizing the standard of mental health care with psilocybin. APEX's strategy is two–pronged, clinical evaluation of drug assets alongside a robust Early Access Program. APEX recognizes and prioritizes Veterans as a patient base with the most severe unmet medical need.

Visit apexlabs.com for more information and follow APEX on LinkedIn, Twitter and Instagram.

Forward–Looking Statements
This release contains certain “forward–looking statements” and certain “forward–looking information” as defined under applicable Canadian securities laws. Forward–looking statements and information can generally be identified by the use of forward–looking terminology such as “may”, “will”, “expect”, “intend”, “estimate”, “anticipate”, “believe”, “continue”, “plans” or similar terminology. Forward–looking statements and information are based on forecasts of future results, estimates of amounts not yet determinable and assumptions that, while believed by management to be reasonable, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Forward–looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability to control or predict, that may cause the Company's actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out here in, including but not limited to: receiving authorization of Health Canada Dealers Licence; filing US provisional patent, the Company evaluating the safety and efficacy of APEX–52 (psilocybin) and APEX–90 (psilocybin) in treating depression in Veterans and patients with Post–Traumatic Stress Disorder; statements related to APEX–52 and APEX–90, including manufacturing, dosing, and trial details; statements made by the Company's executives with respect to Health Canada's Dealer's Licence and capsule patent filing; the Company's efforts around the Early Access Program; statements made relating to Canadian Veteran patients; approvals by the Israeli Ministry of Health and ethics; the inherent risks involved in the general securities markets; uncertainties relating to the availability and costs of financing needed in the future; the inherent uncertainty of cost estimates and the potential for unexpected costs and expenses, currency fluctuations; regulatory restrictions, liability, competition, loss of key employees and other related risks and uncertainties. The Company undertakes no obligation to update forward–looking information except as required by applicable law. Such forward–looking information represents managements' best judgment based on information currently available. No forward–looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place undue reliance on forward–looking statements or information.

SOURCE Apex Labs Ltd.


GLOBENEWSWIRE (Distribution ID 9467934)

Dr. Falk Pharma announces positive results from its pivotal phase 3 trial on norucholic acid in primary sclerosing cholangitis

Freiburg, May 7th, 2025

Study results demonstrate superiority of norucholic acid (NCA) over placebo in the combined primary endpoint. There is currently no approved medicine to treat primary sclerosing cholangitis. The results of the 96–week analysis of the NUC–5 trial will be presented at 2025 EASL Congress in Amsterdam.

Dr. Falk Pharma, a research–based pharmaceutical company specializing in digestive and metabolic medicine, today announced positive results from its pivotal, phase 3 trial (NUC–5) on norucholic acid (NCA) in primary sclerosing cholangitis (PSC).

NUC–5 (NCT03872921) is a double–blind, placebo–controlled trial enrolling 301 patients with PSC, who receive either 1,500 mg NCA or placebo for a total of 192 weeks. At the primary data analysis after 96 weeks of treatment, the primary endpoint of combined partial normalization of blood levels of a liver enzyme linked to PSC (alkaline phosphatase) and no worsening of disease stage on histology was achieved by a statistically significantly greater proportion of patients receiving NCA than placebo. Significant superiority of NCA was also observed in multiple secondary endpoints. The safety results revealed similar rates of study patients with adverse events and serious adverse events between the NCA and placebo groups.

The topline results from NUC–5 will be presented during the Late Breaker session on Saturday, May 10, 2025 at the EASL Congress in Amsterdam.

PSC is a rare, progressive disease in which the immune system attacks the bile ducts in the liver, which leads to fibrosis, or the formation of scar tissue. A considerable proportion of patients develop bile duct, liver, or colorectal cancer, while many others eventually progress to cirrhosis of the liver. No approved pharmaceutical treatment is currently available, and the most effective treatment option is liver transplantation.

“Finding a medicine that effectively treats PSC has been a challenge in the field of hepatology for decades” said Prof. Michael Trauner, Head of the Division of Gastroenterology and Hepatology at the Medical University of Vienna, Austria and principal investigator of the trial. “After so many disappointments in this space, the first positive results from a phase 3 study on PSC is a watershed moment for people with PSC, their families, physicians and the entire PSC community. The results of this study will not only advance patient care but will also give researchers new insights into the disease itself”.

“We are very excited about the positive results of the NUC–5 trial, which was the largest clinical trial on PSC to date which compared biopsies from patients before and after treatment” said Dr. Kai Pinkernell, Managing Director Science and Innovation for Dr. Falk Pharma. “A trial of this duration and involvement is a major undertaking, and we thank all of the participating patients, investigators, and trial staff for their dedication to this trial”.

About norucholic acid

Norucholic acid is an engineered bile acid derivative. Unlike endogenous bile acids, it undergoes no meaningful amidation with glycine or taurine, allowing NCA to be absorbed from bile by cholangiocytes and subsequently re–secreted into bile by hepatocytes in a process called cholehepatic shunting. This together with putative direct anti–inflammatory and anti–fibrotic mechanisms are thought to confer protective effects in PSC. In a previous phase 2 trial, 12 weeks of treatment with NCA was shown to significantly reduce levels of alkaline phosphatase (ALP).

About NUC–5

NUC–5 is a randomized, double–blind, placebo–controlled trial enrolling 301 patients with biopsy–confirmed PSC and levels of ALP at least 1.5–fold greater than the upper limit of normal (ULN). The combined primary endpoint was partial normalization of ALP to <1.5–fold ULN and no worsening of disease stage by histology (Ludwig classification). The key secondary endpoint was partial normalization of ALP to <1.5–fold ULN and no worsening of disease stage by histology (modified Nakanuma staging).

At week 96, 15.1% of patients receiving NCA achieved the primary endpoint compared to 4.2% of placebo patients (p = 0.0048). Similarly, 15.1% of NCA patients versus 5.1% of placebo patients achieved the key secondary endpoint (p = 0.0086). NCA treatment led to improvement by at least 1 Ludwig stage for 25.2% of NCA patients compared to 10.5% of placebo patients (p = 0.0217). Furthermore, worsening by at least one Ludwig stage was observed in 40.4% of placebo patients compared to 20.3% of NCA patients (p = 0.0069). Blood levels of multiple liver enzymes improved under NCA but not placebo. NCA was well tolerated, with similar rates of serious adverse events between the two arms.

NUC–5 is still ongoing, with patients receiving continuous double–blind treatment with either NCA or placebo for an additional 96 weeks. Additional results will be reported after the conclusion of all 192 weeks of double–blind treatment. Patients completing all 192 weeks of double–blind treatment will have the option of receiving open–label treatment with NCA for up to 72 weeks.

Read the abstract here (LBO–001)

About Dr. Falk Pharma GmbH

Dr. Falk Pharma GmbH has been developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis for over 60 years. As the international experts in digestive and metabolic medicine, the company brings together physicians, scientists, and patients to devise new and powerful approaches to patient care. Dr. Falk Pharma engages in pre–clinical and clinical stage research that aims to meaningfully improve therapeutic practice as well as patient health and well–being. A family–owned business with a global presence, Dr. Falk Pharma has ten affiliates in Europe and Australia and is continuously growing. The company has its headquarters and R&D facilities in Freiburg, Germany, its pharmaceutical products are manufactured in Europe, mainly at sites in Germany, France, Italy and Switzerland. Dr. Falk Pharma GmbH employs approximately 1400 individuals globally and 340 in Freiburg.

Further information on Dr. Falk Pharma can be found online: https://drfalkpharma.com


GLOBENEWSWIRE (Distribution ID 1001095027)