Pasithea Therapeutics Corp. a biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders, announced that it acquired AlloMek Therapeutics, LLC (“AlloMek”), a privately-held biotechnology company. AlloMek’s lead therapeutic candidate, CIP-137401, is a potential best-in-class macrocyclic mitogen-activated protein kinase kinase 1/2 (MEK) inhibitor for use in a range of CNS-related indications, including neurofibromatosis type 1 (NF1) and Noonan syndrome, as well as potential synergy with our existing multiple sclerosis (MS) development program. The closing of the acquisition occurred on October 11, 2022.
CIP-137401 is a small molecule allosteric inhibitor of MEK 1/2, a key kinase in the Ras-Raf-MEK-ERK signaling pathway. Existing MEK inhibitors are marketed for a range of diseases, providing evidence for the value of regulating MEK as a drug target, however, they suffer from limitations. Unlike other MEK inhibitors, CIP-137401 is macrocyclic, which displays improved drug-like properties, such as an optimal pharmacokinetic (PK), safety (tolerability) and potency profile, offering potential benefits over other MEK inhibitors. CIP-137401 was designed to limit toxicities and overcome poor pharmacokinetic profiles such as short half-lives and the formation of major metabolites, which result in the limited exposure and stability of known MEK inhibitors.
“The acquisition of AlloMek represents the successful continuation of our business development strategy. Expanding our CNS-focused drug development pipeline with near-term clinical opportunities addressing rare RASopathies positions us for long-term growth opportunities and potential synergies with our existing tolerizing program, which we believe will yield the greatest results for patients, the healthcare community and stockholders,” stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “CIP-137401 was designed to impart optimum drug-like properties potentially allowing for higher exposure, improved efficacy and less frequent dosing which can drive better outcomes as well as improved patient compliance to address issues with existing MEK inhibitors. In addition, we would like to welcome the venture capital firm Connecticut Innovation Fund (CI) to our stockholder registry as a long term focused institutional shareholder who has supported the development of CIP-137401.”
CIP-137401 has displayed efficacy in a range of mouse models of various diseases and has completed pre-clinical testing and animal toxicology studies to support an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). CIP-137401 has already received orphan-drug designation from the FDA for NF1. The Company plans to initially focus clinical development of CIP-137401 on NF1 followed by Noonan syndrome, both rare diseases with significant unmet clinical needs.
Dr. Marques added, “We look forward to bringing CIP-137401 into the clinic rapidly. We currently anticipate filing an IND in the second half of 2023 following good manufacturing practice (GMP) manufacturing of CIP-137401, which is needed for the IND-submission, and initiation of human clinical trials. Our clinical strategy is to pursue the development of CIP-137401 in NF1 followed by Noonan syndrome, which may offer the potential for a rare pediatric disease priority review voucher (PRV) from the FDA.”
Dr. Uday Khire, Chief Executive Officer of AlloMek, noted, “We are excited to work with the esteemed team at Pasithea to get CIP-137401 into patients. We strongly believe in our lead molecule, CIP-137401, which has shown a unique combination of potency, tolerability and PK profile in preclinical settings and could prove to be a sweet spot among MEK inhibitors.”
“We have worked with the drug candidate in our laboratory in a mouse model of a rare inherited heart disease with increased cardiac ERK activity,” added Howard J. Worman, M.D., Professor of Medicine and Pathology and Cell Biology at Columbia University and Chair of AlloMek’s Scientific Advisory Board. “In our model, CIP-137401 was very effective in controlling cardiac fibrosis, extremely potent in reducing tissue ERK activity in vivo and well-tolerated by the animals.”
Lawrence Steinman MD, Professor of Neurology and Neurological Sciences at Stanford University and Chairman of the board of directors at Pasithea, concluded, “AlloMek’s programs are potentially transformative for unmet needs in neurologic diseases, including NF1 and Noonan syndrome and may synergize with Pasithea’s program in MS. Pasithea has experimental data on tolerizing the immune system to unwanted responses to a molecule called GlialCAM, which is similar (molecular mimicry) to Epstein-Barr virus and to members of the Poxvirus family. Published research in Nature showed that kinases are critical for facilitating pathological cross-reaction by adding phosphate residues (phosphorylation) to key amino acids. CIP-137401 has the potential to block phosphorylation of the molecular mimic, and by doing so, help to ameliorate the pathology that triggers MS.”