Drug Discovery and Development Archives - Page 49 of 158

An inside look at Reunion Neuroscience’s psychedelic strategy for treating depression

Greg Mayes, the new CEO of Reunion Neuroscience (TSX:REUN, Nasdaq:REUN), has a more traditional drug development background than many executives in the psychedelic space. He had a successful foray into epilepsy at a company known as Engage Therapeutics. Founded in 2017, Engage was picked up by UCB in 2020.

While Mayes’ background in pharma dates back to 2001 when he was senior counsel at AstraZeneca, his interest in Engage was more personal. “The whole reason I founded that company was because of my son’s epilepsy diagnosis,” Mayes said in a recent interview. “The most common comorbidity associated with epilepsy is depression and anxiety.”

In a recent conversation, Mayes and his colleague, Reunion’s Chief Scientific Officer Nathan Bryson, open up about the company’s strategy and how they foresee the psychedelic market evolving in the coming years.

Could you share more about what inspired you to join Reunion?…

Why Algernon is investigating DMT in stroke rehabilitation

The clinical-stage company Algernon Pharmaceuticals (CSE:AGN; Frankfurt:AGW0; OTCQB: AGNPF) has received approval to run a Phase 1 clinical study of an IV formulation of AP-188.

The study will explore the drug candidate’s potential, a formulation of the classic psychedelic N,N-dimethyl tryptamine or DMT, to treat stroke patients in the Netherlands.

The Stichting Beoordeling Ethiek Biomedisch Onderzoek (“BEBO”), an independent medical research ethics committee, will manage the study.

Algernon decided to investigate the potential of DMT in human studies for ischemic stroke after reviewing data from independent studies demonstrating that DMT can mitigate tissue damage while promoting neurogenesis and neuroplasticity.

To learn more about Algernon’s plans to explore the potential of DMT as a therapy for ischemic stroke, we spoke with Christopher J. Moreau, the company’s CEO.

What led to your interest in DMT as a potent…

Reunion Neuroscience names new CEO to guide development of psychedelic depression therapy

Formerly known as Field Trip Discovery, Reunion Neuroscience (TSX:REUN, Nasdaq:REUN) has announced the appointment of Greg Mayes as its new president and CEO.

Mayes will first focus on completing the company’s Phase 1 clinical trial of its lead asset, RE-104 (formerly FT-104), for postpartum and treatment-resistant depression.

Mayes had held several senior executive roles at pharma companies, including a stint as president, CEO and founder of Engage Therapeutics from 2017 to 2020. From December 2020 to September 2022, he served as president and CEO of the clinical-stage biopharma Antios Therapeutics. At Antios, he led Series B financing worth more than $100 million.

In a LinkedIn post, Mayes described the new role at Reunion as an “ideal opportunity.” “I will be returning to my area of greatest interest and passion – the brain – where we successfully developed a rapid epileptic seizure treatment at Engage Therapeutics through Phase 2 and ultimately sold …

Eisai and Biogen report positive Phase 3 trial results for new Alzheimer’s drug

Eisai and Biogen (Nasdaq:BIIB) today announced positive topline data from a Phase 3 trial of lecanemab for Alzheimer’s disease.

BIIB shares are skyrocketing on the back of the data today. They are up 37.6% at $272.12 apiece in mid-afternoon trading.

Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody. The global Phase 3 confirmatory Clarity AD clinical trial evaluated it for treating mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain.

The drug met its primary endpoint and all key secondary endpoints with what the companies called “highly statistically significant results.” Eisai plans to discuss the data with regulatory authorities in the U.S., Japan and Europe. The company aims to file for traditional U.S. approval and authorization in Japan and Europe by the end of fiscal 2022 (March 31, 2023). Read more

6 biopharma industry trends

[Image courtesy of iStock]

For the past three years, CRB has published an annual report on the life sciences with an emphasis on the biopharma industry.

The latest Horizons: Life Sciences report, clocking in just short of 100 pages in length, relies on feedback from approximately 500 respondents from North America and Europe. A significant number of those respondents are managers, directors, vice presidents and CEOs.

“This issue has primarily focused on research and development,” said Peter Walters, director, advanced therapies at CRB.

Walters said a handful of strong trends resounded across the market as a whole. “The first is this idea of companies diversifying to chase discovery,” he added.

The pandemic helped catalyze innovation across the biopharma industry, but other factors, such as the mapping of the human genome, continue to help drive the field forward. …

Atai Life Sciences launches Phase 1 clinical trial of MDMA derivative

A growing number of companies have launched clinical trials for methylenedioxymethamphetamine (MDMA) and its derivatives.

The most recent is Atai Life Sciences, which saw its share price surge 7.71% in mid-day trading to $3.38 after announcing it had launched a Phase 1 study of an MDMA derivative, EMP-01. The study will focus on post-traumatic stress disorder (PTSD).

Last week, MindMed (Nasdaq: MNMD) announced that it had launched a Phase 1 study investigating MDMA-like substances in healthy volunteers.

Potential for PTSD and beyond

In 2020, Multidisciplinary Association for Psychedelic Studies (MAPS) completed a Phase 3 study of MDMA-assisted psychotherapy focused on PTSD. In addition, MAPS has Phase 2 studies underway for eating disorders, anxiety associated with a life-threatening illness and social anxiety in autism.

FDA has granted Breakthrough Therapy Designation to MAPS to test MDMA in PTSD.

Other companies investigating MDMA inclu…

Kyowa Kirin is targeting disparities in African Americans with rare blood cancer

Kyowa Kirin North America (KKNA) is working to address the racial disparities affecting the care and outcomes of African American patients with Cutaneous T-cell Lymphoma (CTCL).

CTCL is a rare form of blood cancer that first appears on the skin and is often mistaken for more common dermatologic conditions. CTCL can affect the skin as well as lymph nodes, blood cells and internal organs.

Approximately 30,000 people in the U.S. and Canada are affected by CTCL. On average, it takes two to seven years for a patient with CTCL to be diagnosed.

In 2018, KKNA won FDA approval for the CCR4 receptor antagonist Poteligeo (mogamulizumab-kpkc), treating adults with two CTCL subtypes: relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

To learn more about the company’s efforts related to CTCL, we spoke with Lauren Walrath, vice president of public affairs and sponsor of Kyowa Kirin North Ame…

Analysts are bullish on Eli Lilly with its ‘transformative’ drugs

UBS recently issued a report upgrading Eli Lilly (NYSE:LLY) to a “Buy” rating as its diabetes and Alzheimer’s drugs present lucrative opportunities.

According to the report, the pharmaceutical giant’s Mounjaro (tirzepatide) “could be the biggest drug ever.” The type 2 diabetes treatment received FDA approval in May. GlobalData said at the time that tirzepatide could quickly become a mega-blockbuster. Annual sales of the drug could approach $14 billion by 2030, according to Mizuho Securities.

UBS analysts agree, tossing aside previous concerns around data and approval for the drug. Results for the Surmount-1 trial represented a “best-in-class” dataset that included greater than 20% weight loss and other “underappreciated metrics.”

According to UBS, Eli Lilly could hit heights of $25 billion in peak sales for Mounjaro.

The company is investigating tirzepatide for potential indications inclu…

Ultomiris wins approval in Europe for generalized myasthenia gravis

The complement C5 inhibitor Ultomiris (ravulizumab) from AstraZeneca (LON:AZN) has won approval in Europe as adjunctive therapy for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

The regulatory nod represents the first approval for a long-acting C5 complement inhibitor for treating gMG in Europe.

While myasthenia gravis is a chronic autoimmune, neuromuscular disease associated with weakness of skeletal muscles, in gMG, the weakness extends to ocular muscles along with limb and respiratory muscles.

The onset of gMG is often age-related, frequently beginning in women before 40 and for men after 60.

There are approximately 89,000 patients in Europe with gMG.

AZN shares ticked up 0.55% to £9,989.00.

In July, the Committee for Medicinal Products for Human Use (CHMP) recommended approval of the drug for gMG. CHMP based its decision on data from the Phase 3 CHAMPI…

Women in Pharma: Ensysce Biosciences’ CEO aims to combat prescription drug abuse

Lynn Kirkpatrick, the CEO of Ensysce Biosciences (La Jolla, California), oversees the development of novel medicines to reduce or eliminate prescription drug abuse.

Its oxycodone prodrug candidate PF614 is now in a Phase 2 clinical trial. It is designed to offer similar pain relief as current prescription opioids with a limited risk of drug abuse and addiction.

Kirkpatrick has helped the company win FDA’s Fast Track designation for PF614.

She became President and CEO of Ensysce Biosciences Inc. in January 2009.

In the following interview, Kirkpatrick provides an overview of the company’s approach to combat opioid abuse and offers advice on how to succeed in the pharmaceutical industry.

Could you provide an overview of your background and what led you to Ensysce?

Lynn Kirkpatrick

Kirkpatrick: My background started in pharmacy, then medicinal chemistry and pharmacology. …

FDA releases draft guidance to protect children in clinical trials

FDA has published draft guidance to clarify its perspective on including children in clinical trials.

The agency notes that it wrote the draft guidance to help industry, sponsors and institutional review boards (IRBs) protect children in clinical studies testing drugs, biological products and medical devices.

The draft guidance is titled “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”

It includes an ethical framework to safeguard children in clinical research. It provides recommendations for ethical frameworks for IRBs, sponsors and industry. In particular, the document includes information on evaluating whether an investigational therapy is likely to offer a prospect of direct benefit to a child. It also provides an assessment of risk for interventions with the potential of direct benefit and protocols for obtaining permission from a parent or guardian and consent from a child.

FDA’s Office of Pediatri…

BioNanoTech aims to usher in new frontier in protein purification

Startup BioNanoTech has developed a patented platform technology for purifying proteins/antibodies across size ranges.

In particular, the company has developed a new class of Immobilization Metal Affinity Chromatography (IMAC) nanoresins.

“We are building something new at a new scale, and something that can do chemistry and physics on a scale that is more closely to what the target molecules are,” said John Harrold, chief scientific officer at BioNanoTech.

Onyema Osuagwu

While IMAC has existed for more than four decades, the technology traditionally has not been able to capture a wide range of proteins. “This is problematic because these are the starting points for what will be coming later on biologic drugs,” BioNanoTech CEO Onyema Osuagwu said.

Traditional drawbacks of IMAC include metal-ion leaching, size-variant protein capacity and denaturation of some protei…