Aristea Therapeutics Team, CEO James Mackay second from right / Courtesy of Marcy Browe
Aristea Therapeutic is on a rescue mission. The San Diego-based immunology company uses its considerable expertise and experience to locate and develop molecules with a proven or meaningful mechanism of action.
Special attention for Aristea, which comes from Astra Zeneca in 2018, finds valuable therapeutics for rare inflammatory diseases. One such indication is palmoplantar pustulosis (PPP), a rare chronic inflammatory skin condition for which there is no approved treatment in the United States. It causes outbreaks of treatment-resistant sterile neutrophil-filled pustules on the palms of the hands and/or soles of the feet. The Company’s lead asset, RIST4721, which was in-licensed from AstraZeneca, is an oral CXCR2 antagonist currently being studied in a Phase II proof-of-concept study for the treatment of this debilitating condition.
This is a molecule with which James Mackay, Ph.D., founder, president and CEO of Aristea, was already very familiar.
“I was at the portfolio review meeting when [AstraZeneca] made the strategic decision to end the development of this program,” he told BioSpace. The British-Swedish multinational felt strong enough in the breathing space and made the decision to divert funds elsewhere. “At that time, I mentally noted the molecule, because we already knew it was doing what it was supposed to do in humans. It stops the trafficking of neutrophils from the bone marrow to the site of the inflammation, wherever it is in the body. So really, it was medicine looking for disease.
So Aristea went looking for indications where neutrophils are the key mediator cell of disease and identified a group of diseases called neutrophilic dermatoses (inflammatory skin conditions), and then narrowed that down to PPP. In a proof-of-concept study, Mackay shared that they saw “nice activity, especially in patients who were actively burning as they entered this trial.”
Aristea is now entering a Phase IIb dosing study involving 156 patients across three arms. Mackay said the first patient is set to be treated with RIST4721 within the next few weeks, with results expected in mid-2023.
Since the closure of a $63 million Series B funding round in July 2021, Aristea grew from four original team members to ten. And the company is quite comfortable maintaining this size, operating with an outsourcing model.
“Our goal is not to grow the organization, but to keep it small, nimble and focused and to pull expertise where we need it,” Mackay said. “We are drug developers by heart. We’ve been involved in 14 drug approvals in our career, so we really know how to develop drugs.
Chief Medical Officer Nihar Bhakta, MD has held leadership positions at Ardea Biosciences, which was acquired by Astra Zeneca, Bristol Myers Squibb and rock. Focusing on Inflammation and Autoimmunity, Executive Medical Director Fabio Magrini, MD led clinical development teams in rheumatology, dermatology and neuroimmunology, and Stacy Anthony, senior director of clinical operations, was instrumental in getting a product approved at golddemands. Mackay himself served as President and CEO of Ardea after the acquisition by AstraZeneca and was closely involved in the approvals of six drugs in several therapeutic areas.
It is this experience that gives the team a sixth sense for identifying rough diamonds.
“Our goal here is to take molecules that have been rejected by big pharma for various reasons, or other biotechnologies that have taken them through preclinical development but are not equipped to take them into the clinic,” said Mackay. Then, the team returns “to basic science” to search for diseases where these assets can be reused.
The objective then is to ensure that they follow up on the programs. “Our goal is to really generate good drug development plans and good data that will then allow the molecule to progress through our hands or allow a big pharma company to come and pick it up,” he said.
A company that has already shown interest – in the form of a $70 million investment – is neighboring San Diego Arena Pharmaceuticals. In July, Aristea and Arena entered into an agreement strategic collaboration for the clinical development of RIST4721. Aristea received an upfront payment of $60 million along with a $10 million equity investment in Series B funding. In return, Arena scored an exclusive option to acquire Aristea and its CXCR2 programs following the Phase II study in PPP.
In addition to PPP, Aristea is exploring the potential of RIST4721 in Familial Mediterranean Fever, a genetic disease causing high fever and inflammation of the abdomen, lungs and joints, and Behcet’s disease, a rare disease that causes inflammation of the blood vessels throughout the body. In both of these diseases, Mackay said there is “strong evidence that neutrophils play a key mediating role.”
In addition, Aristea and Arena will explore two other neutrophil-mediated diseases: hidradenitis suppurativa (HS) and inflammatory bowel disease (IBD), which is Arena’s area of expertise. With five parallel indications this year, 2023 promises to be huge for Aristea. Mackay shared that data is expected from each program in the first half of 23.
Aristea is currently exploring a range of immunology-based assets to add to the portfolio, Mackay said, adding that the company has agreed a term sheet with a company and is in the process of negotiating 2-3 additional sheets over the course of the year. of the next few years. weeks.
As president and CEO of a company with this particular model, Mackay commented on the virtual nature of the JP Morgan Healthcare conference over the past two years.
“I never liked running between hotels in the pouring rain, so I think it worked really well last year and it’s a very efficient way to do it now that everyone is used to working virtually. “, did he declare. In fact, when Aristea entered into the option agreement with Arena, it did so without the benefit of a single face-to-face physical meeting. Mackay shared that during a key meeting with a major investor, the man’s young son walked into the room with a book. Across the virtual universe, the Aristea team joined in for story time.
“It was one of the most beautiful moments of the pandemic shutdown because it just showed how much more focused we’ve become on the human side of our lives rather than the work side.”