• Introduction
FundaMental Pharma is a cutting-edge neuroscience company with an experienced pharma / biotech CNS drug discovery team
We are developing novel, dual-acting NMDA receptor modulators to provide rapid and sustained relief for treatment-resistant depression (TRD) patients.
Our approach aims for at-home dosing without the need for medical supervision or monitoring. Unlike the current standard of care our treatment is predicted to be devoid of known side effects such as dissociation and hallucinations.
Our clinical candidate, FMP374, is ready for IND-enabling studies and subsequent human testing within 15 months.
Indication & Current Limitations
• Indication & Current Limitations
30
%
Patients failing to respond to antidepressants
TRD affects millions worldwide, with nearly 30% of patients failing to respond to at least two different antidepressants.
The current standard of care (esketamine) serves as the first and only monotherapy for TRD but with serious risks of sedation and dissociation. Patients must be treated under the supervision of a healthcare professional and monitored for at least 2 hours.
The Solution
• The Solution
Dual Acting Modulators of the NMDA Receptor as Novel and Improved Modality for Treatment-Resistant Depression (TRD)
FundaMental Pharma’s dual-acting molecules specifically disrupt a complex formed by the NMDAR with another ion channel known as transient receptor potential cation channel subfamily M member 4 (TRPM4) whilst acting as potent antagonists of the NMDAR.
• PoC
Preclinical PoC in depression models
Rapid onset of action with ≥10-20x margins over exaggerated NMDAR pharmacology which limits the clinical use of esketamine
FMP374 has a higher affinity for the NMDAR compared to esketamine: unique opportunity for an improved oral drug
Novel class of dual-acting and orally bioavailable NMDAR modulators with long-lasting IP protection (composition of matter)
Multiple near-term milestones: IND/CTA acceptance, Phase 1 EEG biomarker readout (predictive biomarker), and Phase 2a TRD patient efficacy data
Clinically validated target & pathway
Highly favorable predicted probability of success
Proof-of-Concept (PoC) in TRD within 3.5 years
Novel mechanism of action with rapid onset and at home dosing
• Our clinical candidate FMP374
Superiority of FMP374 over current standard of care for treatment-resistant depression
• Development
Accelerated development pathway to early PoC (Phase 2a) in treatment-resistant depression within ~3.5 years
The orally bioavailable clinical candidate FMP374 is ready for IND-enabling studies and no showstopper has been identified in preclinical studies supporting candidate nomination. Since the molecule works on a clinically validated drug target and pathway, the development program is substantially de-risked, resulting in a highly favorable predicted probability of success.
