Pasithea Therapeutics, a biotech focused on developing treatments for central nervous system disorders, announced that it had secured a contract with WuXi STA to manufacture the active pharmaceutical ingredient (API) for PAS-004.
PAS-004 is a small molecule allosteric inhibitor of MEK1/2, which plays a role in the regulation of cellular activities, including cell proliferation, survival, differentiation, and motility.
Pasithea plans to explore the drug candidate as a potential treatment for neurofibromatosis Type 1 (NF1) and Noonan syndrome. The company states that PAS-004 is macrocyclic, displaying improved drug-like properties, in terms of pharmacokinetics, safety, and potency over other MAK inhibitors.
According to Pasithea, the good manufacturing practice (GMP) manufacture of drug product is the final requirement to support its investigational new drug (IND) application to the US Food and Drug Administration (FDA). The biotech plans to file its application in the second half of 2023.
The company has already completed pre-clinical testing and animal toxicology studies to support an IND application with the FDA. PAS-004 has received orphan drug designation from the same agency for NF1, and the company plans to start Phase I clinical trials in the second half of 2023.
Pasithea acquired the drug candidate through its acquisition of AlloMek Therapeutics in October 2022, paying $1.05m (€0.97m) in upfront cash and 2.7m share of common stock. The deal also included five-year warrants to acquire a further 1m shares at an exercise price of $1.88 per share, as well as clinical and regulatory event-driven milestone payments.
Emerging from a period of turmoil
It was another of Paisthea’s acquisitions that landed the biotech in trouble with a shareholder group during the course of 2022. In June, the biotech agreed to acquire Alpha-5 Integrin, a pre-clinical stage company developing a monoclonal antibody for amyotrophic lateral sclerosis.
Pasithea agreed to buy the company for $3.75m, payable in 3.26m of common stock, with a further 1m in warrants issued.
At the time, the largest shareholder in Pasithea, Camac Partners, issued a call for a special meeting to remove and replace the biotech’s board of directors for the decision to acquire Alpha-5. The group referred to the acquisition as “dilutive and reactionary.”
In a statement, Camac said, “We find it shocking that the Company’s leadership has now decided to pursue this transaction less than a month after we requested a discussion and indicated opposition to any major deployment of stockholders’ capital. It is clear to us that the sitting directors are more focused on entrenchment than on advancing stockholders’ best interests.”
In December, the two parties reached a comprehensive settlement wherein Pasithea agreed to purchase all of the common stock held by Camac, whilst also paying certain fees and expenses of the group.