Goldenrod Therapeutics plans to study how its enzyme inhibitor can treat Friedreich’s ataxia. Photo via Unsplash

Houston-based Goldenrod Therapeutics, part of Fannin Partners' portfolio, has announced the initial close of a $6.5 million series seed preferred stock round.

The round was led by Ataxia Ventures and an affiliate of Fannin, according to a news release.

Goldenrod Therapeutics plans to use the funding to support manufacturing, formulation optimization, IND-enabling studies and a Phase I study of its drug to treat brain inflammation, known as 11h.

The study will consider how 11h, which blocks the enzyme PDE4, could treat Friedreich’s ataxia (FA), a rare genetic disease that affects movement, speech and balance. To date, other PDE4 inhibitors have proven to regulate neuroinflammation and neuronal signaling, but have had adverse gastrointestinal side effects or have not reached enough of the central nervous system, according to Goldenrod.

The company says its 11h is expected to have "broad applicability" with limited emetric side effects.

“Our 11h program is a next-generation, orally bioavailable, brain-penetrant PDE4 inhibitor, where researchers overcame longstanding limitations associated with earlier PDE4 inhibitors," Dr. Dev Chatterjee, CEO of Goldenrod, said in the news release. "We believe this creates the potential for a best-in-class therapy for Friedreich’s Ataxia and a potential foundation for development across multiple neurodegenerative and neuroinflammatory disorders.”

11h was first developed at the University of Nebraska Medical Center (UNeMed). Houston-based Fannin Partners in-licensed the product 2020 and landed SBIR Phase I funding to support its initial development for opioid use disorder soon after.

Goldenrod has also received funding to study 11h's effectiveness for multiple sclerosis, methamphetamine addiction and cocaine addiction.

Goldenrod says it is developing 11h to target a variety of neurological and inflammatory conditions, including Alzheimer's disease, multiple sclerosis, ALS, substance use disorders, Batten disease, pain and traumatic brain injury.

Nexalin develops non-invasive devices that help reset networks in the brain associated with symptoms of anxiety and insomnia. Photo via Getty Images.

How a Houston company is fighting anxiety, insomnia & Alzheimer’s through waveforms

mental health

A Houston-based company is taking a medicine-free approach to target brain neurologically associated with mental illness.

Nexalin Technology’s patented, FDA-cleared frequency-based waveform targets key centers of the midbrain to support the normalization of neurochemicals through a process known as Transcranial Alternating Current Stimulation (tACS). Delivered via a non-invasive device, the treatment gently stimulates the hypothalamus and midbrain, helping to “reset networks associated with symptoms” of anxiety and insomnia. Early clinical evidence suggests this approach can promote healthier brain function and improved sleep.

Through its recently appointed scientific advisory board (SAB), Nexalin also aims to target Alzheimer’s disease with a clinical development pipeline supported by published data and internal data from studies involving its proprietary DIFS technology. Nexalin’s Gen-2 SYNC and Gen-3 Halo headset delivers the DIFS, which is a waveform that can penetrate deep brain structures implicated in cognitive decline and mental illness.

The board includes experts in neurology, neuroimaging and neurodegenerative diseases with Dr. Mingxiong Huang, Dr. David Owens, and Dr. Abe Scheer coming on board. Nexalin plans to initiate new Alzheimer’s-focused clinical studies in the Q3 2025 by incorporating cognitive testing, imaging biomarkers, and guided metrics to assess treatment efficacy and neural activation.

“I am excited to work alongside Nexalin’s leadership and fellow SAB members to help guide the next generation of non-invasive neuromodulation therapies,” Huang said in a news release. “The intersection of neuroimaging, brain stimulation, and clinical science holds enormous potential for treating neurodegenerative disease.”

Recently, Nexalin’s proprietary neurostimulation device moved forward with a clinical trial that evaluated its treatment of anxiety disorders and chronic insomnia in Brazil. The first of Nexalin’s Gen-2 15-milliamp neurostimulation devices was shipped to São Paulo, Brazil, and the study will be conducted at the Instituto de Psiquiatria University Hospital (IPq-HCFMUSP). The shipments aim to support the launch of a Phase II clinical trial in adult patients suffering from anxiety and insomnia. The Nexalin Gen-2 15-milliamp neurostimulation device has also been approved in China, Brazil and Oman. Its Gen 1 device first received FDA clearance in 2003, according to the company's website.

The company also enrolled the first patients in its clinical trial at the University of California, San Diego, in collaboration with the VA San Diego Healthcare System for its Nexalin HALO, which looks to treat mild traumatic brain injury and post-traumatic stress disorder in military personnel and the civilian population.

Nexalin previously raised $5 million through a public stock offering.
FibroBiologics has opened a new 10,000-square-foot Houston lab to scale up research efforts and pave the way for in-house manufacturing. Photo via Fibrobiologics.com

Houston regenerative medicine company expands lab for future trials

new digs

A Houston regenerative medicine company has unveiled new laboratory space with the goal of expanding its pioneering science.

FibroBiologics uses fibroblasts, the body’s most common type of cell, rather than stem cells, to help grow new cells. Fibroblasts are the primary variety of cells that compose connective tissue. FibroBiologics has found in studies that fibroblasts can be even more powerful than stem cells when it comes to both regeneration and immune modulation, meaning they could be a more versatile way forward in those fields.

In 2023, FibroBiologics moved into new lab space in the UH Technology Bridge. Now, with its new space, the publicly traded company, which has more than 240 patents issued or pending, will be even better equipped to power forward with its research.

The new space includes more than 10,000 square feet of space devoted to both labs and offices. The location is large enough to also house manufacturing drug product candidates that will be used in upcoming trials. Additionally, the company reports that it plans to hire additional researchers to help staff the facility.

“This expansion marks a transformative step forward for our company and our mission,” Pete O’Heeron, FibroBiologics founder and CEO, said in a news release. “By significantly increasing the size of our lab, we are creating the space and infrastructure needed to foster greater innovation and accelerate scientific breakthroughs.”

The streamlined, in-house manufacturing process will reduce the company’s reliance on external partners and make the supply chain simpler, O’Heeron added in the release.

Hamid Khoja, the chief scientific officer for FibroBiologics, also chimed in.

“To date, our progress in developing potentially transformative therapeutic candidates for chronic diseases using fibroblasts has been remarkable,” he added in the release. “This new laboratory facility will enable further expansion and acceleration of our research and development efforts. Additionally, the expansive new space will enable us to bring in-house currently outsourced projects, expand our science team and further contribute to the increased efficiency of our R&D efforts.”

This news arrives shortly after a milestone for the company in its research about neurodegenerative disease. Last month, fibroblast treatments in an animal model study demonstrated a notable regeneration of the myelin sheath, the layer that insulates nerves and is worn down by disease.

“Confirming remyelination in a second validated animal model is an important step in our research and development efforts, offering fresh hope for patients with demyelinating diseases, including multiple sclerosis,” O’Heeron added in a separate release. “These findings advance our mission to develop transformative fibroblast-based therapies that address the root causes of chronic disease, not just their symptoms, and reflect our dedication to pushing the frontiers of regenerative medicine."
Daniel Barvin has a neurodegenerative disease in his near future. He joined Houston-based Coya Therapeutics to help fight for a cure to the aggressively deadly ALS. Photo via Getty Images

How this Houston innovator is using his personal connection to ALS fuel his fight for a cure

guest column

We can never predict how our lives will turn out, but then maybe some of us can. Genetic testing showed that I, like my grandfather, aunt, uncle and father before me, would most likely die of amyotrophic lateral sclerosis, more commonly known as ALS, and/or frontotemporal degeneration (FTD) in my 40s.

Being 36, it’s possible that fear could have overtaken my life, but instead I chose to fight for every chance to change not only my life, but the lives of millions who are suffering or may one day suffer from neurodegenerative disease.

ALS is a rare disease that robs one of their ability to control their muscles, leading them to lose their ability to walk, talk and eventually breathe. Eighty percent of cases are sporadic (of unknown origin) and 20 percent have known genetic causes.

When I learned that I carried the C9ORF72 genetic variant, a causative genetic variant for ALS/FTD) my first instincts were to help others understand their status and where they could turn for help. I saw a vacuum for resources and understanding in the genetic ALS space and I knew that thousands were suffering in darkness.

Through the efforts of many, we created the first ever nonprofit – Genetic ALS & FTD: End the Legacy – focused on fighting for the genetic ALS and FTD communities. After making great strides to fight for our rights and access to care, I was asked if I could help my current CEO, Howard Berman, commercialize Dr. Stanley Appel’s regulatory T Cell (Treg) therapy for ALS.

I joined Coya Therapeutics in 2021 as the first employee, working to build a company that would one day bring life changing therapies to patients. Coya’s therapies are based on Dr. Appel’s discovery that neurodegenerative diseases drive an inflammatory response. As inflammation rises, it damages regulatory T cells, and when Tregs are damaged, inflammation becomes a persistent condition driving degeneration and eventually death.

It was at that point that my life changed from the advocacy world to the therapeutic world. Now over three years later, we are closer than ever to making a paradigm change for how patients with ALS and other neurodegenerative diseases are treated.

At Coya, we believe that combination biologics are the future of treating neurodegenerative diseases. COYA 302 is our lead asset, which has shown promising results in a proof-of-concept study released in March of 2023. We are currently working towards a double-blind, placebo-controlled trial for COYA 302 in ALS set to kick off later this year.

I never wanted to live a life so damned by disease, but when put between a rock and a hard place, the only choice is to fight. I don’t know how my life will end, but I hope that my children will know that I faced a great challenge head on with pride and resilience.

In the end, it is the combination of both the worlds I work in that lead to better outcomes for patients, raising awareness and lifesaving research. This ALS Awareness Month, please join us and our partners like the ALS Association, End the Legacy, and I AM ALS in raising awareness about these conditions, their risks, and treatment options.

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Daniel Barvin is the vice president of operations and patient advocacy at Coya Therapeutics.

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European spacecraft developer expands to Houston with U.S. business, new lab

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European aerospace manufacturer The Exploration Company has established its first U.S. entity and named Space City as its headquarters.

The company announced earlier this month that it has launched TEC Federal to support U.S. government customers and agencies, and to scale The Exploration Company's engineering operations in the country.

Mark Kirasich serves as president of TEC Federal. Kirasich most recently served as the senior director of human spaceflight at Blue Origin after a nearly 40-year career at NASA.

The Exploration Company is developing the reusable Nyx space vehicle. Nyx is designed to take off from any heavy launcher in the world. It will then dock at space stations, retrieve up to 3,000 kilograms of cargo, splash down and return the cargo to Earth. The company aims to make Nyx fully reusable for up to 10 missions, making it a more affordable and sustainable option for aerospace missions.

The Exploration Company completed a successful drop test of the spacecraft in May in the Mojave Desert. The company says Nyx is slated to perform its first flight demonstration in 2028.

In addition to launching the Houston business, The Exploration Company also opened its new Rapid Innovation Lab near Houston's NASA Johnson Space Center on Space Park Drive.

The Exploration Company opened its Rapid Innovation Lab earlier this month. Photo via LinkedIn

The Rapid Innovation Lab features a full-scale mockup of the future Nyx crew capsule as well as ongoing development and testing of the Nyx cargo capsule, according to the company.

The Exploration Company says the new lab will allow its engineers, designers, and operators to prototype and test crew interfaces. It will also support partnerships with NASA personnel and astronauts.

“Houston gives us direct access to the people and expertise that have built and operated human spaceflight systems for decades. We’re excited to invest and expand around that— engineers, operators, and astronauts working together and moving quickly towards building a crew capsule.” Hélène Huby, founder and CEO of The Exploration Company, said in a blog post.

According to The Houston Chronicle, The Exploration Company has about 30 employees in the Houston area.

The company was founded in 2021 by Huby, a French rocket scientist, and has raised more than $350 million in venture capital. It operates out of Germany, France, Luxembourg, Spain and Italy, with offices in the U.S. and the United Arab Emirates. It is also developing a reusable, high-thrust rocket engine known as Storm.

UH lands $4M NIH grant to study early signs of autoimmune disease

NIH funding

The University of Houston recently received a $4 million National Institutes of Health grant to support a 10-year longitudinal study to identify the earliest biological markers of autoimmune disease.

Led by Chandra Mohan, the Hugh Roy and Lillie Cranz Cullen Endowed Professor of Biomedical Engineering, the study aims to examine what causes Systemic Autoimmune Rheumatic Diseases (SARDs) and to identify targets for future treatments. The study will be carried out in collaboration with Dr. Karen Costenbader at Harvard Medical School, Boston.

SARDs include conditions like rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome and systemic sclerosis—all are considered chronic diseases currently without a cure. Autoimmune diseases affect over 30 million people globally, according to UH.

SARDs occur when the body’s immune system attacks healthy, non-threatening tissues and organs. According to UH, in these diseases, the body often attacks nuclear antigens, creating anti-nuclear autoantibodies, which can be early detection signs for SARDs in more than 50 percent of patients, Mohan says.

Researchers will study blood samples and environmental exposure over the 10 years to better understand anti-nuclear autoantibodies.

“Collectively, these studies will help identify the genetic, environmental and cellular factors that are operative at the two steps of SARD development, namely the emergence of anti-nuclear autoantibodies and disease onset,” Mohan said in a news release. “ More importantly, these studies will highlight functional molecular pathways and mechanisms that may be operative at each step."

Mohan predicts that looking at SARDs’ shared characteristics, rather than each disease individually, could help identify more treatment methods.

“Individual SARDs have been examined in silos without an attempt to discern shared underlying features at the molecular level,” he added in the release. “Current understanding of the initial (and likely shared) origins of SARDs is only rudimentary but urgently needed to develop means for prevention and treatment.”

Earlier this year, UH also received an $11 million NIH grant to conduct a first-of-its-kind study of early language development in children ages 18 to 24 months. Read more here.