Target
Through its internal research, Akaal Pharma identified the S1P1 receptor as a key therapeutic target with broad and significant relevance across multiple disease indications. Existing S1P1 agonists are associated with well-known limitations, highlighting the need for a highly selective, safe, and efficacious S1P1-targeting drug to overcome the shortcomings of current therapies. The S1P1 mechanism of action (MoA) is implicated in various physiological processes and has been clinically validated, reinforcing its potential.
Akaal Pharma’s pipeline includes both topical and oral development programs designed to maximize the therapeutic potential of S1P1 modulation.
Topical
Akaal Pharma has successfully completed a Phase 2 clinical study involving 139 patients with atopic dermatitis associated with pruritus.
Takp-119 demonstrated significant efficacy without the typical side effects seen with other drug classes—such as immune suppression, irritation, skin thinning, or discoloration.
While we are advancing this lead candidate as a topical treatment for a range of inflammatory skin conditions, our primary focus is on atopic dermatitis and the associated symptom of pruritus. This first-in-class topical program aims to develop dermatological therapies for mild to moderate atopic dermatitis and pruritus, offering a non-steroidal alternative with a favourable safety profile.
Oral
S1P1 receptor modulation plays a critical role in inflammatory and autoimmune disorders and holds potential across other therapeutic areas. A well-balanced, safe, and effective oral S1P1 modulator has long been sought.
In a Phase 1 clinical study involving 40 healthy volunteers, Akaal Pharma’s lead candidate Oakp-11 demonstrated dose-dependent drug exposure without significant immune suppression, bradycardia, or other adverse effects.
Oakp-11 has shown a breakthrough profile compared to existing S1P1-targeting drugs, with superior efficacy and safety in both preclinical and clinical studies. It is the first in its class to exhibit all features together:
- High receptor selectivity
- Strong receptor activity with an excellent safety margin
- Minimal and reversible lymphopenia
- Cardiovascular safety
- A favourable pharmacokinetic profile
This best-in-class oral program is focused on developing treatments for autoimmune diseases. Given its novel mechanism of action and superior safety characteristics, Oakp-11 is also being explored as a first-in-class candidate for neuropathic pain.
