Loop Bio
A novel therapy for OCD and Tourette Syndrome.
Loop Bio is developing a proprietary 2PAA prodrug targeting the overactive cortico-striato-thalamo-cortical (CSTC) circuit implicated in obsessive-compulsive disorder (OCD) and Tourette Syndrome (TS). The program is built on a molecule with 130 million+ prior patient exposures, eliminating the side-effect burden of SSRIs and antipsychotics that define current standards of care. Founded by a physician with lived experience of OCD and a world authority on OCD and TS pathophysiology.
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The problem
No new OCD drugs have been approved in over 20 years. The only FDA-approved options for Tourette Syndrome are antipsychotics with severe side effects. Patients deserve better.
- OCD — 10M+ Americans affected. 60% of patients respond inadequately to first-line SSRIs. Higher doses cause worse sexual dysfunction, weight gain, and emotional blunting.
- Tourette Syndrome — 400K+ US patients. Only three FDA-approved drugs, all antipsychotics carrying movement-disorder risk. $6.5B market by 2030 (4.2% CAGR).
- >50% of TS patients have comorbid OCD. One asset addresses both indications.
The solution
2PAA is the active metabolite of betahistine, a drug prescribed worldwide for vertigo with more than 130 million documented patient exposures and an adverse-event rate of roughly 1 in 100,000. In two clinical observations, betahistine produced a marked reduction in OCD symptoms, including a clinically significant response in the second case.
Loop Bio has identified 2PAA as the active entity and is developing a purpose-built prodrug library to deliver it to the central nervous system.
Target product profile
| OCD | Tourette Syndrome | |
|---|---|---|
| Population | Adjunctive refractory / monotherapy | 2nd-line moderate-severe / all TS |
| Endpoint | Y-BOCS II superior to placebo | YGTSS TTS superior to placebo |
| Safety edge | No sexual dysfunction or emotional blunting | No movement disorders, sedation, or weight gain |
| Dosage | Chronic, oral, once daily | |
Why now
- Field is wide open. No pharma competitors in late-stage OCD trials.
- Ecopipam validates the TS path. Phase 3 success; NDA approval expected 2026.
- Psychedelic alternatives are 5+ years away. No competing novel programs in pipeline.
Preclinical evidence
Two-plus years of translational work from the Pittenger Lab at Yale demonstrates that betahistine, 2PAA, a 2PAA prodrug lead, and ecopipam all mitigate stress-induced stereotypy in validated models, while modulating the relevant CSTC circuitry.
- Stress-induced stereotypy (ARS): dose-dependent reduction comparable to ecopipam.
- c-Fos circuit mapping: normalization of activity in key OCD/TS regions.
- Prepulse inhibition (PPI): rescue of sensorimotor gating deficit, a translational TS biomarker.
- qPCR in dorsal striatum: concordant GABA/glutamate expression profiles between betahistine and 2PAA.
Intellectual property
- 150+ new chemical entities — composition-of-matter claims for betahistine and 2PAA prodrugs.
- 20+ indications — method-of-treatment claims across OCRD, tic disorders, and glutamate excitotoxicity.
- Protection to 2047+ — 20+ years of exclusivity remaining.
The team
- Nicolas Cuba, MD — Founder & CEO
- Former Founder & CEO of Alco Therapeutics (exited to Biohaven, March 2024). Led the 2PAA / betahistine program since 2020.
- Christopher Pittenger, MD, PhD — Co-founder & SAB Chair
- Mears & Jameson Professor of Psychiatry, Yale. World authority on OCD and TS pathophysiology; pioneered histamine and glutamate research in the field.
- Biohaven (NYSE: BHVN) — Shareholder & Board Seat
- Shareholder, royalty rights, and one board seat. Acquired Alco Therapeutics IP in 2024.
Scientific Advisory Board & Consultants
- Bruce Car, DVM, PhD, DACVP — SAB Member; CSO, Biohaven; former CSO, Agios. 25+ years at BMS, 18+ registrations.
- Matthew State, MD, PhD — Clinical Dev / Neuroscience Consultant; Chair of Psychiatry, UCSF. Pioneered genetics of autism and Tourette.
- Stephan Loose — BD Consultant; Managing Director, Old Street Strategy.
- Ric Stanulis, PhD, DABT — Toxicology Consultant; CEO, Akkeri. Board-certified toxicologist, 25+ years.
The ask
$2M through SAFEs. First investor committed.
Nine-month runway funds the derisking package: GLP toxicology, CMC, regulatory filing, and target identification — bridging to a $13M Series A and first-in-human studies.
Why invest now
- Focused founders. Specialist leadership with a prior successful exit.
- $3B+ market, untapped. No new OCD drugs in two decades.
- De-risked safety. 130M+ exposures to the parent molecule.
- IP protection to 2047+. 150+ NCEs, 20+ indications.
- Clear path to first-in-human. $2M bridges to Phase 1.